Medicines, Poisons and Therapeutic Goods Act and Regulation
Jasmine Frisina
Thank you all for joining us this evening for the understanding the New South Wales Medicines, Poisons and Therapeutic Goods Act and Regulation, Key Changes and implications for Doctors webinar. My name is Jasmine and I will be your RACGP host for this evening. Before we get started, I would like to make an acknowledgement of country. We recognise the traditional custodians of the land and sea on which we live and work, and we pay our respects to Elders past, present and emerging. I would also like to acknowledge any Aboriginal and Torres Strait Islander colleagues that have joined us online this evening.
I would like to introduce you to our presenters for this evening. Monique is the principal officer at the New South Wales Ministry of Health and manage the review of the Poisons and Therapeutic Goods Act, which led to the passing in New South Wales Parliament of the medicines, Poisons and Therapeutic Goods Act 2022. Monique has a focus on developing clear and enforceable laws and informed and considered policy in consultation with health practitioners and other stakeholders. David is currently the Chief Pharmacist and Director of Pharmaceutical Services with the New South Wales Ministry of Health, supporting the regulatory frameworks and guidance relating to medicines and poisons and the quality and safety for the use of medicines. Our facilitator this evening is Dr Natasha Feingold. The learning objectives that are being shown on the slide are the learning objectives that we aim to cover within this session. Please take a moment to read these, and I will be handing the session over to David to commence the presentation.
David Ng
This evening we are hoping to talk to you a little bit and hopefully give you a better understanding around some of the regulatory frameworks in New South Wales. Now, predominantly we are going to present to you the New South Wales Medicines, Poisons and Therapeutics Goods Act and Regulations. Now the act itself has not commenced and well, the act itself has passed Parliament but we are currently working through the regulations themselves. Now some of the things that we are going to present to you will include things that might change when the act commences together with the regulations and so some of the things that Monique might be sharing with you this evening will include both things. Some of the things when the act commences will not change and some of the things that you are already required to do, but there are some changes, now hopefully through the presentation is that we will make it clear those obligations which are required of you now and where there are nuances or where some of those things might change throughout the evening. Now, if some of it might sound confusing because we might intertwine what you are already familiar with what might be coming, as Jasmine and Natasha has mentioned is that there is the Q&A box. We hope that I mean, this evening is really to try and demystify some of the regulations and the act for you, and so this is really your time. So if there are things that perhaps is not clear today or things that you are needing to do today as well as what might come in the future now, we are hoping that the regulations, due to some delays will be finalised later this year and hopefully before Christmas, but that is leaving it a little bit too late in the year to commence, so we are hoping that the commencement of the act and the regulations will occur in early 2026. Some of this information that you are here tonight is still in draft form, and there may be some changes when we commence, but there will be frequently asked questions and there will be communications to the college to you with respect to your obligations. If there are things that are not clear to you with respect to practice this evening as well as what might be coming make use of the Q&A box, which is why we are here. I will pass it back to Monique, and Monique has been intimately involved with the act and the regulations, and so you have got no better expert this evening to take you through some of your obligations today as well as in the future.
Monique Rayes
Thank you, David. Thank you, Natasha also for facilitating. We will start with the next slide. This is a very daunting and confusing looking slide, and that is because the medicines regulatory framework is quite complex, and as medical practitioners your primary role is clinical and it is completely understandable if these legal obligations are not at the forefront of your mind, but nonetheless, these legal obligations are imposed on medical practitioners because with great power comes great responsibility, said Spider-Man. Very briefly though, we have got the blue cloud there. That is the Therapeutic Goods Act and it is administered by the Therapeutic Goods Administration. They oversee manufacturing and importation and of medicines and they list medicines on the Australian Register of Therapeutic Goods. All medicines really have to be registered on the ARTG unless they are exempted from registration or there is an approval to supply the medicine in Australia without having it registered, so that is the likes of the cannabis medicines psilocybin, MDMA and nicotine vape. Anything that is registered on the ARTG are assessed for quality, safety and efficacy, so if it is not on the ARTG then it is not assessed for quality, safety and efficacy. That is the Therapeutic Goods Act's remit. There is then the National Health Act and largely in relation to medicines. It is about the funding and subsidy of medicines under the PBS. When you apply for a PBS authority, this is not the same as the lawful authority to supply medicines in New South Wales. It only allows for the subsidy of medicines, and then you have in the green cloud the national law which regulates professional practice and conduct of medical practitioners. AHPRA and the Medical Counsel administers this act and it includes the registration of health practitioners. The Drug Misuse and Trafficking Act provides for offences for unlawful possession and supply of high-risk substances such as schedule 8 medicines and schedule 9 substances like heroin and so on, and that is administered by NSW police. All of these interact with the Poisons and Therapeutic Goods Act or the medicines, Poisons and Therapeutic Goods Act. At the centre there with all the stars around it, that is the Poisons and Therapeutic Goods Act or Medicines and Therapeutic Goods Act which will replace the poisons, as David said in 2026 when we commenced that act. This is the law that authorises the prescribing, supply and administration of medicines in New South Wales as well as regulates how these medicines are stored, labelled, packaged, recorded, the supply, recorded and disposal. We did review the Poisons and Therapeutic Goods Act because it is almost 60 years old and it was made for the times when there was one GP practice in a town and one pharmacy, and as we know, there are now new models of care that we need to recognise, and there are new ways of delivering healthcare. It needed to be updated, and as David said, the Medicines, Poisons and Therapeutic Goods Act did pass parliament in November 2022, we just have to finalise the Medicines, Poisons and Therapeutic Goods Regulation this year and then we can commence both act and regulations. When we reviewed the Poisons and Therapeutic Goods Act, we developed the new act with the aim of recognising safe practice and making that lawful, so recognising new ways of delivering healthcare like telehealth and other digital advances like e-prescriptions and emerging treatments like biologicals. We also aim to reduce regulatory complexity for health practitioners and the industry and improve the emergency preparedness learnings from COVID. We also sought to align more closely with national standards such as the Commonwealth Poison Standards and other intersecting laws. We also sought to balance access to medicines with public health and safety by adjusting controls around high-risk substances. In summary, as a GP, you do need to be aware of these laws when prescribing and supplying medicines but hopefully this overview has given you a little bit of an understanding that there are many laws out there and there are different agencies dealing with these different parts of the broad medicines regulatory framework. Let us go to the next slide. Thanks, Jasmine.
What is the role of pharmaceutical services and what does it mean to GPs. Who are we for you. The objective of pharmaceutical services is the same objective as the Medicines, Poisons and Therapeutic Goods Act, and that is to protect public health and safety in the supply of medicines and poisons in New South Wales. We regulate the supply of medicines at each stage of the chain of supply of medicines. From when it is made, when the medicine is made to when a wholesaler holds the stock and supplies it onto to the next person, whether that be a pharmacist or a medical practitioner or a retailer. All the way to the point of supply to the patient or the end user. We identify each person in this chain of supply to be able to allow them, to authorise them to be able to handle the medicines. We identify the health practitioners such as medical practitioners who we know are trained and skilled to be able to prescribe, supply, administer medicines. For this, we rely on the national law, which then tells us, well, this person is a registered medical practitioner and it is within their scope of practice to prescribe, supply, administer medicines. Then we say all registered medical practitioners can prescribe, supply, administer. We do undertake compliance and enforcement activity to keep the public safe, and in practice, our activities would include issuing approvals to practitioners to prescribe or supply high risk medicines in high risk circumstances. We issue authorities to researchers and analysts who need access to high risk medicines. We inspect wholesaler premises and we also manage SafeScript New South Wales, the real time prescription monitoring system that provides information about patients prescribing and dispensing history for monitored medicines. We manage the notifications that we receive from you that is required by the regulation, so that is loss or theft of schedule eight medicines and schedule 4D medicines, and we also take notifications of lost, stolen or forged prescriptions, and these notifications can easily be made online. We can leave a link with Jasmine to send out to you. Let us go to the next slide. Thank you.
Today, we thought we would focus on the issuance of approvals to practitioners to prescribe or supply high risk medicines in high-risk circumstances. Firstly, I wanted to point out that approvals is a word that we are now using. We have replaced authority with approval in the new legislation, and this is because we wanted to reduce the confusion between the PBS authority and an authority under the New South Wales Poisons and Therapeutic Goods Act of the upcoming medicines, Poisons and Therapeutic Goods Act. When you apply for PBS authority, as I said earlier, it is simply for the subsidy of the medicine, but the authority or approval that we are talking about here is one that allows you to be able to prescribe, supply, administer under New South Wales law where it is prohibited without an approval. These are the circumstances on the screen where you require an approval to prescribe and supply, and of course, I just wanted to also point out that an approval from New South Wales Health is not to replace your clinical judgement in treating your patient with the medicine. It is serving a purpose that is about public health risk and you do still need to apply your clinical judgement when prescribing and supplying these medicines. First of all, if prescribing, supplying or administering a schedule eight medicine to a substance dependent person, then you need an approval. The difference between the old Poisons and Therapeutic Goods Act and the new medicines Poisons and Therapeutic Goods Act is under the poisons we define a drug dependent person and that is in accordance with the act section 27 and let me just bring that up, that is a drug dependent person means a person who has acquired as a result of repeated administration of a drug of addiction or a schedule eight medicine or a prohibited drug within the meaning of Drug Misuse and Trafficking Act. An overpowering desire for the continued administration of such a drug. That is under the current laws the poisons, but under the new Medicines Act I am going to call it Medicines Act, it is such a long title. Under the Medicines Act, we refer to a substance dependent person and we refer to the diagnostic tools ICD-11 or DSM-5 to help you diagnose whether a person is substance dependent but we do limit the definition to dependence to a schedule eight or a schedule nine substance because under ICD-11 or DSM-5, there is dependence to nicotine or caffeine is included in that definition, but for the purposes of this act, it is only about dependence to the schedule 8 or schedule 9 substances or strictly it is prohibited scheduled substances, prohibited drugs and prohibited plants within the Meaning of Drug Misuse and Trafficking Act, but for the purposes of this, let us just say it is the schedule 8 and schedule 9 substances. That is the first rule. The second rule is psychostimulant medicine, so dexamphetamine and lisdexamfetamine and methylphenidate. This is an existing control, so it will just continue. Anytime a medical practitioner wishes to prescribe, supply, administer a psychostimulant, then an approval is required under current laws and the upcoming laws. The next one is about the 100mg oMEDD. Under the new laws, you will need to apply for an approval when prescribing, supplying or administering any of the following fentanyl, hydromorphone, morphine or oxycodone. If the doses exceed 100mg oMEDD in combination. What is oMEDD? oMEDD is the oral morphine equivalent daily dose. It is a measure to assess the potency of an opioid by converting its daily dose into an equivalent dose of oral morphine. This allows clinicians to evaluate and compare different opioid treatment plans, helping to identify risks thresholds and promote safe, effective pain management. There are published online calculators that can be used to calculate the oMEDD, and again we can leave you with the links to those calculators. There is an apple, so on the phone and that that is actually a new control and that is something that was asked of us when we went to consult with medical practitioners and specialists to make sure that we do include such a control. The next one is chronic treatment for greater than three months. There is going to be a change to this. Currently, under the current Poisons Act, if you prescribe, supply certain medicines for greater than two months, then you need to apply for approval. Under the new Medicines Act, you need to apply for approval if the treatment is greater than three months because we were told that the acute treatment is under three months and chronic treatment is three months and over. That was the feedback we got from medical practitioners, and so we have adjusted it from two months to three months. This does not apply to every medicine. This is only medicines, schedule 8 medicines that are in injectable or intranasal preparations. It applies to alprazolam and flunitrazepam in any preparation and methadone, but not if it is for OTP. If it is chronic treatment i.e. treatment is continuous for more than three months with any of those that I have mentioned, then an approval is required. And lastly the nominated schedule for medicines. These are medicines that have been the Commonwealth's Poisons Standard appendix D has recommended controls on these medicines needing to be restricted to certain specialists. These are medicines such as clomiphene, thalidomide, ambrisentan and dinoprost. This is just us taking the controls that are recommended under the Poisons Standard and applying it in New South Wales law. The full list of those medicines will be in the regulations once that has published. There are exemptions that will be applying to the requirement for approval. Relevantly to GPs, there is the replacement practitioner. This is the locum provision. We did not want to call it locum because we were told that is not the right word, so we have just chosen a different term completely. It is replacement practitioners. If you are a medical practitioner holding an approval to prescribe a supply for any of these substances or any medicine that requires an approval, but you go away or you go on leave, then you can nominate a practitioner to take over the care of the patient, and that medical practitioner will not need to apply for an approval. They can continue the care of the patient or it could be anyone in the same practice. If you are in a GP practice and you are a practitioner that is looking after a patient, you hold the approval, you go and leave. Anyone, any other medical practitioner in the practice can continue the care of the patient under that approval without having to apply for another approval. There are also exemptions that apply to hospitals, exemptions that apply, and this is a new one for palliative care treatment, and there is a definition of palliative care in the regulation, but if the treatment is for palliative care then there is an exemption you do not need to apply for approval, and the other exemption is the three day urgent pain relief. If you are needing to prescribe a supply urgently any pain relief that requires approval, you do not need to do so if it is just for three days, so that is another exemption.
At this point, I just also wanted to mention that New South Wales, the Ministry of Health recognises co-management and transfer of care arrangements and this is specifically for the purposes of assessing applications for New South Wales health approvals. A co-management or transfer of care arrangement is an agreement between a relevant specialist, and this is going to be identified for any of these approval requirements. An agreement between a relevant specialist and a GP to collaborate on or continue the care of a patient, specifically in the prescribing of medicines requiring New South Wales Health approval. For example, there is a pain specialist who is looking after a patient and they are collaborating with a GP on caring for the patient then the GP can prescribe or supply under a co-management arrangement with this practitioner. There still would be a requirement to apply for approval, but there will be a box that you can tick to say you are in a co-management arrangement and that is a declaration that you indeed are in a co-management arrangement, and your application will be considered in a way that applies to co-management arrangements. Let us have a look at some of these scenarios for approvals. Let us go to the next slide. Thank you.
This is going to be an interactive part of our webinar. I will set up some scenarios and then we will go to a poll to have some multiple choice answers to questions after this setting out of the scenario. Scenario one is oxycodone for pain. We have Daniel. He is a 45-year-old man recovering from a recent crush injury at work. Daniel recently saw a pain specialist at the local hospital to discuss his analgesia. Daniel is attending your practice to discuss the outcome of his appointment with the pain specialist, and he is asking for a prescription for the new analgesics that the pain specialist has recommended. The pain specialist is recommended to increase Daniel's dose of oxycodone from 30 mg bd to 40 mg bd and to add morphine for breakthrough pain 5 mg four times a day prn. Before issuing Daniel with a new prescription, you remember that when prescribing fentanyl, oxycodone, hydromorphone or morphine in total daily doses greater than 100 mg oMEDD combined, an approval from New South Wales is required prior to issuing the prescription. If we look at the doses, the oMEDD calculator should tell you that oxycodone is 1.5 times more potent than morphine. A 60 mg daily dose of oxycodone is a 90 mg morphine dose, so changing that from 30 mg bd to 40 mg BD would then mean it goes from 90 mg oMEDD to 40 times 1.5 times two, so that is 120 mg of oMEDD, and then the breakthrough pain morphine is another 20 mg. The total oMEDD for this patient will be 140 mg. That would mean that you would require an approval from New South Wales Health. Jasmine shall we go to the poll? In scenario one, Daniel, the question is what do you do in this scenario? Immediately issue the prescription as what the pain specialist is recommended, ask the patient to go back to the pain specialist as this requires New South Wales Health approval or you check SafeScript and if appropriate, apply for approval under a co-management arrangement with the pain specialist or you send the patient to emergency. I will leave you a few minutes.
Dr Natasha Feingold
Monique, I was going to say that somebody put in the chat that thank goodness the name has been changed from authority to approval because it really clarifies the confusion that so many people have. We just wanted to give applause on that.
Monique Rayes
Good. I am glad to hear it. It is feedback that we have received quite a few times. Jasmine, let me know when it is time to go to the next. Natasha, shall we discuss this? Yes, perhaps. Let us discuss this particular question in this scenario.
Dr Natasha Feingold
Can other people see the voting, Jasmine?
Jasmine
Yes.
Dr Natasha Feingold
It looks like there is an overwhelming response with checking SafeScript and then applying for approval with co-management. We do have a gripe that we get, quite annoyed that pain specialists cannot act on their own and they require us. Sometimes they will tell us what to do and then write scripts that have been there. Monique, is that the correct answer?
Monique Rayes
That that is that is pretty good answer. You could do any of these things, but the third one is a good answer. You could absolutely do that. You can check SafeScript, and if there are no red flags then, you could certainly apply for approval under the co-management arrangement that we mentioned earlier, but it is not wrong to say, you could ask the patient to go back to the pain specialist because maybe the pain specialist should have issued a prescription. Why not? As GPs, you are not precluded from writing a prescription if you apply for approval and you are in a co-management arrangement.
Dr Natasha Feingold
How long do you think these approvals take?
Monique Rayes
This is the good thing about SafeScript. It has allowed us to be a lot more efficient with these assessments. Sometimes it can be real time approvals, particularly if the criteria has been met. In this case, it is likely to be almost immediate, if you tick the co-management arrangement box, but of course, that is a declaration and you are expected to be in a co-management arrangement if you tick the box.
Dr Natasha Feingold
There was a comment on the chat box that if you send the patient back to that pain specialist, it obviously means that patients going without medication, which prolongs their suffering and it is not really their fault, and general practice is trying to balance all that out and while still doing everything correctly medically, legally.
Monique Rayes
Yes. The patient does always come first. All right. Shall we go to the next scenario, Natasha?
Dr Natasha Feingold
Yeah, let us do that.
Monique Rayes
Okay, so scenario 2. We have Jessica, who is a 34-year-old patient. She has just moved from interstate and she has decided to see you as her GP moving forward. You have taken the history. Jessica has severe anxiety. She has trialled several different medicines and non-pharmacological treatments to control those symptoms. Other than that, there is no significant medical history. She explains that 0.5 mg of alprazolam a day is effective for managing her symptoms, and you are able to verify via transferred medical records that this treatment has been prescribed continuously by her previous treating physician over the last three months. Jessica has been referred to see a psychiatrist by her last doctor for further assessment and management of her condition. However, the appointment is scheduled next month and she has run out of medicines. Through your examination and assessment, you agree with the diagnosis and the treatment, but of course you would like to consult with the psychiatrist and seek their opinion as well. In the meantime, Jessica does need a prescription for the alprazolam and she does not meet substance dependence criteria. You have checked ICD11. We will go to the poll. What would you do in this scenario? Immediately issue a prescription with repeats? Apply for approval via New South Wales with the intention to issue a prescription for one-month supply? Send the patient away as you do not prescribe benzodiazepines on request to new patients or nothing? The specialist appointment is soon enough. We will give you a few minutes.
Dr Natasha Feingold
Monique, somebody concerned that these patients are not being treated appropriately.
Monique Rayes
Fair enough. I am going to leave that with you, Natasha.
Dr Natasha Feingold
Daily alprazolam might not be the best treatment for severe anxiety. That might just be me, but they are examples to have some discussions around.
Monique Rayes
These are just to be able to elicit the requirement for approval. It is possibly not necessarily the best medical treatment. I apologise.
Dr Natasha Feingold
That is why you send them to us, right?
Monique Rayes
Yeah. These are purely hypothetical situations.
Dr Natasha Feingold
Yeah, exactly. Okay, so there are a few different answers here. We have most people saying they would apply for approval via SafeScript with the intention to issue a prescription for one-month supply, but then some people did say they would send the patient away as prescribing benzodiazepines on requests to new patients is not something that they. We have a few other lower numbers picking the other options. Monique, what do you think? What would you say about that?
Monique Rayes
You could do any of these other than the first one because there is a requirement for approval prior to prescribing in this case. You would not issue a prescription without applying for approval and you would not be precluded from applying for an approval from New South Wales Health through SafeScript with the intention of prescribing for a month until Jessica sees the psychiatrist. That seems to be the overwhelming majority. I would agree with that also. It is your prerogative to do the other options, but the second option is a viable one.
Scenario 3. Ann is a 42-year-old patient and she is from Sydney and she is visiting family just before she leaves the country for a long period of time and this is according to Ann, and she says that she has run out of fentanyl patches for her cancer pain. She is on other medicines for pain relief, but she has plenty of those. She just wants some fentanyl patches. You have asked for her GP details, but she says that he is closed for the Easter break, so the GP is uncontactable. She is in tears. She is blaming herself for not having enough of the fentanyl. What would you do? She is asking for six months' worth of fentanyl. Option 1, you check SafeScript New South Wales for prescribing and dispensing history of monitored medicines? You call the Commonwealth's prescription shopping program to see if anything pops up? You issue a prescription for one patch or refuse to prescribe and ask Ann to return in three days to allow time to contact treating physicians or all of the above? I will give you a few minutes.
Dr Natasha Feingold
Monique, the feedback is that this situation is a lot more realistic. This is what we deal with. Okay, well, it looks like most of the participants were thinking that we would do all of the above. We have a few that would say they would just check SafeScript. Nobody is calling the Commonwealth's prescription shopping program anymore. Except for that. All of the above. They are only doing that and then some are issuing the prescription for one patch. What are your thoughts about that Monique?
Monique Rayes
Again, you could do any of these. Only one, only two but ideally you could do all three. The third one is you could issue a prescription for one patch or refuse. Technically that could be two different answers. If you did all of the above, that would probably be ideal. To note though that the Commonwealth prescription shopping line sets a very high threshold before you can get the information that a patient has to be shopping around for 25 S8 medicines or listed medicines that they are tracking. It is a very high threshold just to keep that in mind when you do call them.
Dr Natasha Feingold
Can I ask, what is the difference? Is there more information that you can get from the prescription shopping hotline versus SafeScript? Is it different or would it be the same?
Monique Rayes
The New South Wales SafeScript New South Wales is just the prescribing and dispensing history in New South Wales whereas the prescription shopping line is Nationwide, so there is that difference, and as I said, there is a very high threshold to be able to be listed on the prescription shopping line but all information should be taken into account, and if you have more information that is better. More is more in this case.
Dr Natasha Feingold
Does it matter which state the doctor is in? If a doctor is, say, working in New South Wales but the patient moves, say they moved here from WA. Can you access the information, equivalent of the SameScript there?
Monique Rayes
Each real-time prescription database is state or territory based, but when the idea was first conceived, the idea was that we would all link the databases so that you could go in and look at a nationwide database. That has not happened yet. Each database is state and territory based, however, depending on the laws of the state or territory, they could allow others to view their database. It really depends on the state or territory. In New South Wales, we have legislated that others can view our database if they want to.
Dr Natasha Feingold
Okay. Great. I do not think there are any more questions. Maybe we can move on to the next scenario and then we will have some time for questions.
Monique Rayes
Sure. Scenario 4 is about verification of prescriptions. A pharmacist calls you to verify a prescription as required under the regulation. If the pharmacist does not know the doctor who has written the prescription, does not know the handwriting, does not know the doctor, does not know the patient, then they must verify the prescription that the prescriber in fact has written the prescription. The pharmacist calls you and asks whether you, in fact, wrote a prescription for this person for oxycodone 80 mg twice a day, quantity 80 for John Peters on 7 May. You check your records. You have no record of that patient, and you do not recall writing such a prescription. Let us go to the poll. What is the likely scenario? The prescription has been fraudulently altered from a previously issued prescription with different details? Someone has stolen your prescription stationery and is generating prescriptions signed in your name? Someone knows your login details and has generated the prescription under your name or all of the above may be true?
Dr Natasha Feingold
This sounds like it could be something from a TV show. Monique, another question. This is also related to the last case, but with the prescription shopping hotline, is it only looking for medications that have PBS subsidies?
Monique Rayes
Yes, I believe that is correct.
Dr Natasha Feingold
It looks like overwhelmingly all of the above may be true. A few points for the other answers, but it looks like pretty dodgy scenarios that could be happening.
Monique Rayes
It is more common than you think, maybe you know, but it is quite of high illicit value, oxycodone. On the illicit market, it is it is quite high value. There is demand for forged prescriptions and fraudulently obtaining the medicines unlawfully.
Dr Natasha Feingold
You do not happen to know, if this situation is happening, what we do as GPs after that? Do we go to the police?
Monique Rayes
If we go to the next slide. Here we are. If you have lost or your prescription pad is stolen, you can report that to us, and we can then list it on our website so that pharmacists can look at that page and see whether there have been stolen prescriptions and they can be more vigilant dispensing off those prescriptions, they might have to always verify. You can assess security of prescription stationery and passwords. If such an incident did happen, you could communicate to all staff and review protocols to mitigate the risks. If there are crimes under the Drug Misuse and Trafficking Act, offences under the Drug Trafficking Act in terms of fraudulent, altered prescriptions and forgeries and so on, and that can be reported to police. The requirement to report to pharmaceutical services is on a pharmacist. If a pharmacist knows that a prescription has been forged or fraudulently altered, then the pharmacist must call the police and report that fact but the offences under the Drug Misuse and Trafficking Act can be acted on by any person.
David Ng
Natasha, I thought it might have been there because I think this is quite important. I think there is a question about electronic prescriptions and forgeries. We are aware of quite a number of instances where electronic prescriptions have been forged and in most cases, they have been picked up by pharmacists just performing their due diligence. Some of the ways that pharmacists might verify a prescription is legitimate, as you may know, is ringing the number that appears on the prescription, for example, and often what we found when we conducted our investigations is obviously the phone number is not to your practices, to someone else who is also a bit mischievous in that context, who would then identify themselves as a legitimate doctor. At the same time, what has also occurred is that there are websites that are created with your name on it. The other way of verifying your identity and getting your phone number is most of us use Google and we might Google Dr. Smith, for example. What is happening, as Monique has highlighted, is that oxycodone and some of these medicines are high value is that there are instances where there are websites that are set up with your name on it. I think, as the old saying goes, from time to time, it is always worthwhile to Google yourself just to make sure that there are not illegitimate websites or other identities of yourselves. We have picked up some of these electronic forgeries. In that situation, when it occurs and it usually the pharmacists have been pretty good in notifying us and then we take action. If you do come across instances where you are aware that prescriptions are being issued using your credentials, whilst notification to us is not mandatory, there is a national process that is currently being established which means that the jurisdiction where these forgeries are identified will take responsibility and advise the Australian Digital Health Agency. It is possible for them and the IT vendor to cancel the tokens that are issued under that identity. It is important, in paper prescriptions, pharmacists can usually retain them and therefore they cannot be used, but electronic prescriptions, the tokens are a little bit harder but the Australian Digital Health Agency and the vendor can deactivate those tokens so that they can be supplied ongoing.
Dr Natasha Feingold
Thanks for clarifying that. That was the last scenario we have.
Monique Rayes
Yeah, that was the last scenario, which is quite good timing. What is next? As we have already mentioned a few times, we are looking to have the Act and Regulation commence in 2026 subject to approval of the regulation mid this year, so that gives the industry and the professions around six months to prepare to implement under the new Act and Regulations. We will be publishing some fact sheets and updating our website to provide you with the information of the changes from the old act to the new act and what these changes mean to you. Please visit our website if you would like to keep informed and we will hopefully also be having more webinars like this or other material put out to help you understand the changes. Thank you very much for the opportunity to speak with the members of RACGP this evening.
Dr Natasha Feingold
Thanks so much. It was super helpful to learn about all that. We just get so little education about these type of things. So helpful to have it clarified and see some real world examples. Thank you, Monique and thank you, David for all your input. We do not have too much time, but maybe we might have time for any other questions. We might have a few minutes for one or two questions in the chat box, if anyone else has any questions. There is an interesting website somebody has posted about how much people are paying for oxycodone and other opioids and other S8 on the street, so you can have a look at that if you wanted to. Otherwise, it looks like you have answered everybody's questions.