Australian Health Practitioner Regulation Agency - Restriction: Prohibition on access to unapproved therapeutic goods
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Restriction: Prohibition on access to unapproved therapeutic goods

National Restrictions Library 2.0: This restriction applies to restictions imposed or accepted from 16 September 2024. For restrictions imposed or accepted before this date please see the National Restrictions Library 1.0.

Restriction description

A practitioner with this restriction must not practise until we publish approved practice locations. When assessing suitability of practice locations, we check that the practitioner has systems to ensure their compliance with the restrictions.

A practitioner with this restriction must not access unapproved therapeutic goods, including medications, listed in the restriction. The listed medications can be an entire group of similar medications or only specific substances. This requirement refers to practitioners prescribing, administering, dispensing or handling those medications.

We define ‘unapproved therapeutic goods’ as goods, devices or substances that the Therapeutic Goods Association (TGA) has not evaluated for quality, safety, effectiveness or performance.

The practitioner must not apply for or have approval from the TGA to access any of the goods listed.

The practitioner must have their practice audited. The audit is to confirm that the practitioner complies with the restrictions. We must approve the nominated auditor and audit plan to ensure that the audit will focus on the required areas.

The practitioner must show evidence of the completed audit.

We usually apply this restriction due to concerns about a practitioner's health, conduct or performance.

We monitor compliance by checking that:

  • a senior person at each practice location understands the requirements of the restriction
  • the practitioner has disclosed all practice locations
  • the practitioner meets all required timeframes
  • the practitioner has their practice audited regularly
  • the practitioner has not applied for or been approved for unapproved therapeutic goods using information from the TGA
  • the practitioner has not prescribed the medications using independent information from state and territory drugs and poison authorities.

We also monitor compliance by checking the audit findings.

Full text of restriction

  1. From #start date# the practitioner must:
    1. not access unapproved therapeutic goods including any pharmaceutical item containing #cannibinoids/ psilocybin/ MDMA (3,4-methylenedioxy-methamphetamine)#
    2. not apply or hold approval with the Australian Government Department of Health Therapeutic Goods Association (TGA) for access to unapproved therapeutic goods via the special access scheme, or as an authorised prescriber.
  2. The practitioner must undergo audits of their practice (the audit), including any supporting records. 
    1. The audit and the audit report are to focus on access to unapproved therapeutic goods and must include, at a minimum, #audit requirement#. 
    2. The practitioner must complete a period of audits with the first audit being within #timeframe# of approval of a practice location and thereafter on a #frequency# basis or as otherwise directed.
  3. The practitioner must comply with the Ahpra Protocol: Prohibition on access to medication(s) (269 KB,PDF) and the Ahpra Protocol: Complete audit (293 KB,PDF) in force at the date these conditions are imposed and then as updated from time to time. 

‘Unapproved therapeutic goods’ are defined as goods, devices or substances that have not been evaluated by the TGA for quality, safety, efficacy or performance.

You will receive a monitoring plan that details contact information, due dates, and the information you will need to provide to show that you are complying with your restrictions.

Forms

Please contact your case officer for more information. 

For general information see our Frequently asked questions about Monitoring and compliance page

If you have not yet received contact details for your case officer, please email your enquiry.

We are here to support and guide you through your compliance. 

The contact details for your case officer are included on all our correspondence with you.

We also encourage you to use independent support services, including those provided on our Practitioner support services page.

You can also contact your legal representative or professional union to support you.

You are not permitted to practise without an approved and published practice location.

You must not commence practise or recommence practise until after we have assessed and approved a practice location and the approval has been published on the public register. 

We will consider any practise without published approval to be a breach of the restrictions and may take further regulatory action, even if your nominated practice location is subsequently approved.

For these restrictions, we need to be confident that there are adequate processes for monitoring your compliance with the restrictions at each practice location. 

We consider how appropriate a practice location is for a practitioner who is subject to these restrictions. We place significant weight on practice locations having independent people who we can communicate with and seek assurance from about the practitioner’s compliance.

Generally, we will provide a further opportunity to nominate a different practice location, or to address any shortfalls in the nomination. 

You must continue to not practise until such times as the approval of a practice location has been published on the public register. 

The senior person plays an important role in protecting the public as they are responsible for the provision of accurate practice information, and are, in general terms, the primary contact for us to seek assurances from regarding your practise and whether there is any evidence that your health condition is impacting on your ability to practise safely. The senior person should be sufficiently independent from you to be reasonably relied upon by to allow for adequate monitoring.

You should notify your case officer using the contact details on your monitoring plan. You will be required to nominate a new Senior Person within 14 days.

Send us confirmation  that you no longer practise at the location. For example, a termination letter.

We will remove the publication of the practice location from the public register.

If you only had one approved practice location, you must stop practising until we publish another approved practice location on the public register. If you want to start practising at a new location, you must nominate a new practice location in line with the requirements of the restrictions and the Protocol. 

If you had more than one approved practice location, you can continue practising at your other approved practice location while we assess your new nomination. 

In considering the appropriateness of a practice location for a practitioner subject to these restrictions, we place significant weight on the presence of independent persons with whom we can communicate and seek assurances from regarding the practitioner’s compliance. 

If there is no senior person or you are the senior person at the practice location, we may refuse your nomination of a practice location or may seek additional assurances that you are complying with the requirements of the restrictions. These may include the requirement for regular audit and independent reporting from local drugs and poisons authorities or Services Australia. 

You must notify your case officer of any incident where, due to a medical emergency, you accessed medication that you were not permitted to access or were otherwise non-compliant with your restriction.

We will assess whether the circumstances were such that compliance with the condition would directly affect your ability to provide care that would have a direct benefit to a patient in a medical emergency.

A medical emergency is defined as an event where it is not possible or reasonable to have a patient with a serious or life threatening condition seen by another practitioner or transferred to the nearest hospital.

We will treat any failure to notify of non-compliance in the circumstances of a medical emergency as a breach of the condition and may take further action in relation to a breach of conditions.

It is recommended that you do not commence your audits prior our approval of your nominated auditor and audit plan. If we does not approve your nomination, any audits undertaken prior to gaining approval may not be counted towards the requirements of your restrictions and you may be required to complete additional audits at your own cost. 

It generally takes between 4 and 6 weeks for approval of a nomination. 

Audits via videoconference may be considered. Both you and your auditor should confirm in your plan that you have access to reliable internet, web camera, speakers, and microphone and how you will securely share patient records and personal information. Audits via audio communication only is unlikely to be approved. 

The audit plan should also specifically address how the audits will be conducted in the event of issues involving bandwidth, video quality, broadband interruptions, and other technical issues. 

Only audits which include real time interaction with your auditor will be approved. Pre-recorded video and audio content will generally not be considered sufficient in isolation. 

If you maintain paper-based records, it is unlikely that a virtual or remote audit will be approved. 

If your restrictions require you to complete audits at specified intervals and you are unable to complete an audit at the scheduled time due to the availability of your nominated auditor, you may be eligible to apply for an extension of time to complete the audit. Extensions are considered on a case-by-case basis.

If you are ineligible or fail to apply for an extension, then a failure to complete the required audit at the required frequency may be considered non-compliance with the restrictions. We may consider whether this requires further regulatory action. This is considered on a case-by-case basis and includes consideration of the original concerns resulting in your restrictions, any other safeguards in place such as supervision and whether the frequency of the audits was important for the assessment of implementation of remedial actions and or evidence of sustained adjustments to your practice. We may, amongst other actions decide that you must undertake additional audits. 

If a report indicates there are or continue to be concerns that relate to your conduct or performance, we may consider whether this requires any further regulatory action. This is considered on a case-by-case basis and includes the nature of the original concerns resulting in your restrictions, any remedial action taken by you including completion of education, seeking input from peers and or safeguards that provide adequate protection to the public such as supervision.

You must contact your Ahpra case officer or team as soon as possible if you have had a change of circumstances or are unable to comply with the requirements for any reason. See your monitoring plan for contact information. 

You may be able to apply for a change in your restrictions, or an extension of the date of commencement of the requirement for supervision. Circumstances are considered on a case-by-case basis.

 
 
 
Page reviewed 13/09/2024