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Presentation: Changes to codeine product access
Codeine up-scheduling workshop, Melbourne, 28 November 2017
For further information about changes to medicines containing codeine, see the Codeine information hub.
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- Presented by: Adj Prof John Skerritt, Deputy Secretary for Health Product Regulation, Department of Health
- Presented at: TGA workshop: Codeine up-scheduling, Melbourne, 28 November 2017
- Presentation summary: This presentation provides an overview of the background to the decision to up-schedule codeine-containing compounds.
Changes to codeine product access: background to the decision to change from over-the-counter to prescription only
Adjunt Professor John Skerritt
Health Products Regulation
Commonwealth Department of Health
TGA workshop: Codeine up-scheduling, Melbourne, 28 November 2017
Well good evening everyone. We might as well make a start and we've got a few people, especially people from places like Monash, who are probably still battling down the so-called Monash to get here. I do appreciate people coming for a 6 to 9 p.m. event. I know it can be challenging, especially when you're in healthcare because it's a fairly full-on challenging profession, whether you're a pharmacist, a clinician or in in other support roles. And to come to something like this after a full day of work for most of us is challenging, but I do appreciate you having the commitment and the time.
It's interesting to be back in this particular room because this room seems to associate itself with divided and controversial areas of work. It was almost 18 months ago that I think I was last in this room talking to a group, and that was about medicinal cannabis. And of course, medicinal cannabis attracts its own fair degree of controversy. So, the purpose really of tonight, and we do want it to be a discussion rather than bashing your ear, especially at the end of a long day. But we've got a few speakers who'll introduce a few things and explain things.
So, the purpose is just to provide a little bit more background to the reasons for the decision to up schedule codeine containing medicines from over counter to prescription only. That's all very nice, big bad government's made a decision but we need to go further than that, and I think it's important to have a discussion about well, with this decision having been made, apart from understanding a bit of a reasons for the decision, because your colleagues, clients, yourselves, your stakeholders may ask you what it's all about, are to talk about such things as alternatives to codeine containing over counter medicines; to talk more broadly about management of pain.
I think it's quite interesting if you look across health at large, and I guess in one of my responsibilities, I am one of the people who has a responsibility for the whole Australian health system, the over hundred billion dollars of government expenditure in health and aged care. I don't get to keep a percentage of it unfortunately or a very low percentage known as my salary. But, in looking across the whole health system, one of the challenges with management of pain is, of course, it's often a sign or symptom of other things ranging from cancer through to arthritis through to overuse for joint.
And when you work with individual groups that say, specialize on something like diabetes or asthma, it's a much more clearly defined paradigm, and you have a more clearly defined ability to have a pharmacist, GP, patient, support, individual, family member discussion then for pain at large. And I think we're only just realizing, and perhaps one of the positive things to come out of the codeine discussion, is actually the need for a greater focus on pain itself and on working with chronic pain, especially non-cancer pain.
Working also with dependent patients. One of the other things that has come out of working with codeine is, of course, the people who are dependent on codeine often present in a very different way to pharmacies or to healthcare professionals, or even to friends and family members, from those who may have a dependence say on illicit opioids or even high-dose prescription opioids. Codeine dependent people often are still functioning working in their jobs and so forth, but the wheels are slowly falling off. And again colleagues will talk about that.
Access to health care professionals is important, and as a drug goes to prescription only, as we talk about other strategies, especially those involving non-pharmaceutical interventions, it's important, especially for those who are further away from a centre such as Melbourne, and in rural and more remote areas, to actually have a clear understanding of, especially if they have been in a habit of using codeine, of what their alternatives are. So hopefully, we've got a fairly integrated set of discussion starters tonight.
Now as MC, I'm introducing several people plus I'm also giving a bit of an introduction myself. I should introduce myself. I'm Deputy Secretary for the Commonwealth Department of Health. There's a few of us so it's a old-fashioned title, the secretary bit. When I first became a deputy secretary some eight or nine years ago, my then teenage daughter thought it was because of my typing speed- true story sadly. But it's just one of the number twos in the National Health Department. I've got particular responsibilities for therapeutic goods, medicines devices, blogs and so forth, as well as regulation of drugs, so drug control. And it's a sad indictment on the Americanisation in our society but the way I often describe at a dinner party what I do is that I sort of have responsibility for FDA and the DEA, except the Australian versions. This is a generation of kids that have to be warned not to phone 911.
Okay, so I was just going to provide a bit of background and talk about what this rescheduling means because it's a little bit arcane bureaucrat stuff, and then touch lead into some of the later presentations.
So, even though codeine, at least today, is an over counter medicine, what is actually working in the body is morphine. When you say that to someone, because everyone's heard of morphine, it actually comes as quite a surprise, and that is actually the root of some of the challenges with codeine. The challenge often is that different people metabolise it at different rates. Some individuals metabolise it very quickly, especially some of Middle Eastern and African descent, but also a number of Caucasian descents. And so, there's been cases where babies have been breastfed with someone taking codeine. The babies have a rapid metaboliser gene and there's been deaths, for example, in North America for breastfed babies just with codeine turned into morphine in breast milk.
One of the other challenges of course, the chronic use, and all opiate analgesics, except for use in cancer pain, are not indicated for chronic use, but it's still very quite significant use. There's a fair bit of evidence and I'll just touch very briefly on that of the harm and misuse of over-the-counter codeine. It's not just the higher doses of codeine in prescription medicines that have been associated with morbidity and mortality.
Now, the other challenge, of course, with OTC codeine is that in its OTC presentation, it's always combined with something else, with paracetamol or ibuprofen normally, sometimes aspirin. And we know that paracetamol, even though it's so widely used, is actually hepatotoxic above about four or five grams a day. And so, if as last time or two times ago, when I was in Melbourne at a rural doctors meeting, we heard stories of people taking 48, 72 codeine paracetamol tablets a day. Can you imagine what 48 or 72 times 500 milligrams of codeine does to your liver? I mean, it's worse than cirrhosis. Ibuprofen, of course, has significant gastrointestinal problems, and often, some of the symptoms of codeine overuse have often come from intestinal problems such as bleeding and so forth or odd liver problems.
And the other challenge is in most people, it's not a particularly effective analgesic, and there's a couple of reviews there. This talk, although slides are slightly different order, is available in hard copy out at the front table, and please take copies because we don't want to take them home.
Codeine has and does kill people, and just a couple of the studies that mention codeine specifically in Medical Journal of Australia. 1437 codeine related deaths and that is actually fairly old date of 2013. The numbers were going up when they stopped measuring, and while more people died from high dose opioids, the Oxycodones and so forth, or Fentanyl, the numbers are still quite high for codeine. And so in their work, about 40% of the deaths they could attribute to either OTC or to prescription, the other 60% they couldn't tell, and this is a common problem with coroner's data. Unless the packet is next to the deceased.
And in the case of that, 40% of a time, it was actually OTC codeine. And that equates to about a hundred deaths a year that can be attributed to OTC codeine. Similar numbers and you've got to divide those numbers by five for the national coronial information system. And so those three are expected to have codeine involvement. Now again, it wasn't codeine alone, and it's and it's very rare for someone just to be taking codeine alone. But as a trigger, so for example, alcohol codeine, benzodiazepines and codeine were in many of those cases so there is evidence of mortality with over the counter codeine.
Some recent work that's been published by the Australian Institute of Health and Welfare. This is the annual, or actually it's not, every couple of years as a drug survey where people are surveyed on their drug taking behaviour. One in 20 people misused a pharmaceutical OTC or prescription, and one in eight have done this in their life. Knowingly take more than they are indicated. That was a definition of misuse. And interestingly, painkillers containing opioids were the highest and most commonly used misused pharmaceutical.
And look at this one. When they asked people, when they surveyed 25,000 in this survey, when they surveyed people what they'd be used, OTC codeine and these numbers add up to more than a hundred because some people misuse more than one thing. But 75% of people who misused a pharmaceutical product misused over the counter codeine.
So, as you're aware, the decision was made to reschedule codeine and I just want to unpack what scheduling means. And it's sometimes called classification in other countries like the UK. And so chemicals and medicines, and Australia is unique because we jumble up chemicals and medicines. I don't know who dreamt this up but it's a bit of a jumble but that's what we have. So, medicines are either two, three, four and eight. They don't use one and they don't use zero. And what scheduling is all about is the level of access and regulatory control. So, Schedule 8 medicines are locked up in safes and pharmacies. Schedule 9 medicines are prohibited. They're things like LSD, for example, in Schedule 9. Schedule 4, of course, prescription only. Schedule 3, pharmacist involvement in intervention. Schedule 2, available in a pharmacy, and general sale, which doesn't have a number is from a supermarket or petrol station.
Now, if you've got these, how do you determine what goes into what category? And there's a thing known as a scheduling policy framework. And so for example, if you're a pharmacist only medicine, substantially safe with pharmacist's intervention, use of a medicine at expected doses doesn't produce dependence. Risk can be minimized by pharmacists. They're the Schedule 3 characteristics for a pharmacist only medicine. And so, at the moment, until February first, codeine preparations at low levels are either in cough and cold preparations are Scheduled 2, or at higher levels up to 12 milligrams of codeine base, are pharmacists only medications, again combined with one other active substance. And there's some examples of products.
So, who decided to make this change? Well, the way it works is that anybody, any individual, any organization; it can be academic, it can be a company, it can be a group of clinicians, it can be a group of pharmacists, or it can be an individual. They can apply to say, no we think that should be in Schedule 3 not Schedule 2, or we think that should be in Schedule 8, not Schedule 4. We think that should be in Schedule 2, not Schedule 4 and so on. So, for example, you've seen things down schedules such as the PPIs, Nexium. These are ? that's been down scheduled from Schedule 4, for example, to Schedule 3 and 2 and so on.
So, we receive two applications at the same time. Now, the submitter is actually kept confidential; that's the law of a land. So, we receive two applications at about the same time to consider that, and as long as it's not a frivolous application, we have to consider it and I'll talk about how the process worked because it was fairly rigorous and with lots and lots of steps of consultation and other things.
Now, the actual decision wasn't made by the Minister. Quite appropriately, government said this is a medical scientific decision; a senior doctor should make it not a politician. And so, the decision is made by a senior doctor and they have to look at all those characteristics for 2, 3, 4 see where the fit is. And they have to consult and may have to get advice from a committee. There's a thing called a Ministry of advisory committees called the Advisory Committee for Medicine Scheduling, and there's public consultation.
So, what sort of thing does a person have to look at? They have to look at these characteristics, risks and benefits, purposes, toxicity, potential for abuse. That's written into the law, Section 52e of our act. So, when they looked at Schedule 3, which I've just shown you and Schedule 4. Elements require medical, dental intervention, evaluation of the use of a substance, therapeutic doses could produce dependence, adverse events, margin of safety needs, therapeutic and toxic dose. Has the subject contributed to communal harm? That's a bit of old-fashioned, it really means public health impacts on the community.
So, you can see that it's another step up from pharmacy only. So here's the process and I'm not going to go through all the steps, but I guess the main take out from this is that there were a heck of a lot of steps. Between almost three years ago receiving two separate applications, a committee being involved on several separate occasions, including a separate safety committee somewhere along the line not shown here. Public consultations, a regulatory impact statement on the economic impact of a scheduling. And finally a decision on the 20th of December 2016, and it just so happened it was late December 2016. If it was the 24th, you could have called it a conspiracy theory but it just so happened, and you can see the whole decision process took two years of deciding, and we've given 14 months for the decision to be actually implemented.
There was a whole lot of evidence and I've talked about some of the problems with codeine before. We did some safety reviews in-house, and we also got University of Sydney and the Georgia Institute to do some other. And you can see the sort of lack of evidence, limited evidence, contra-indicated and children. And internationally, there's also a fair groundswell. Increasingly, countries are also making codeine medicines prescription only. Now I talked about how we did all this over two years, the French did it in one night when one day, there were some deaths of some young adults and teenagers, including some children of some quite well-known and influential French people. And overnight, the French minister said, okay, as of tomorrow, prescription-only. Bang. We we've done in a slightly more finessed way.
So, I've talked about the public consultation periods. We talked about a public consultation with a lot of other bodies about the impacts of a scheduling, including the state and territory health departments. The decision came out on the 20th of December 2016. Now, that was also building on a regulation impact statement talking about the economic, social and regulatory impacts of a change, and also modelling in an economic sense what the impact is because there's been a lot said about this will cause major pressures on the health system. It'll do this, it'll do that. And so we got KPMG, they obviously were independent enough and respected enough as an economic modelling organization to go away and talk to people, look at all the data and look at all the numbers, and come up with some figures.
We also notified the companies. Now, some of these companies will move their products to prescription-only, others will cease marketing them, and still others have not shown their hand yet. They'll obviously have to decide by February 1st.
So, what did KPMG come up with? Well there will be some increase in the numbers of GP consultations, but in their modelling and their interviews of patients, and of doctors, and a pharmacist, they felt that a lot of people won't go to a GP solely for codeine prescription. So, the average person who sees a doctor and there's a tremendous spread here, but on average, it's about four times a year, the average Australian. Now, some people obviously go 15, 20 times a year, and some people never go. But the average Australian goes every 12, four and a half times a year, depending on the region and depending on the group. So, about every 12 weeks or so, people go to the doctor. Often they'll do that, or if it is a chronic pain, we're actually encouraging them to seek advice because self medication with codeine for the chronic non-cancer pain is not really indicated.
Now, KPMG did say, yes it will be an extra cost to Medicare. 204 million over ten years, averaging 20 million a year, so that is a known cost to Medicare of this change. But much of that cost is actually going to be having the discussion about how to manage your pain rather than, I've just come up, write me a prescription, goodbye. Because part of what we're working with a lot of the clinical groups in these discussions is actually about having the discussion. Even if you're busy, don't just don't fill a script. If someone comes to you, have a discussion about non-drug treatment. Have a discussion about alternatives. People talk about codeine for migraine. Codeine was around for migraine fifty years ago before newer drugs or the triptans came in, for example. So, have that discussion.
However, there's an overall net positive benefit to society, and again these aren't my figures. This is calculated by health economist at KPMG. 5.2 billion over ten years; shame we can't use it to pay off the deficit. Prevention of accidental deaths. They actually didn't model the hundred deaths, they actually modelled five a year in mere modelling. Improved quality of life for those who are dependent. Reduction of adverse events for overdose. And there's also a recent study from South Australia which showed that every codeine related admission from OTC codeine misused, cost the South Australian Health System $10,000 per admission. And the other morbidity factors.
Now, even though the Commonwealth made a decision, it actually is not implemented by the Commonwealth because states and territories, these things are regulators of pharmacy and pharmacy practice, and of access to medicines in their jurisdictions. Now, states and territories adopt this by reference. Now, there are ways where states and territories don't have to do this. So, for example, if Victoria decided not to adopt some of the medicinal cannabis scheduling, and they have their own system for cannabis products grown here in Victoria. I can have a go at Victoria. I used to live here in Melbourne and I used to be in the Victorian Government, and I called it that then.
So, Victoria did it differently, so states do have that possibility, and a lot of the discussion that's been running in recent months is about just whether that will happen. And at the end of the day, it's up to the state and territory governments. We don't think so, given that we're now about nine weeks away, and there's a thing called Christmas and New Year and everyone's playing cricket and tennis and stuff. We don't think that any of the states are going to do something different but that's purely up to the states. Generally, people are saying, look, national uniformity is better. You don't want one lot of access in Wodonga, and one lot of access in Albury.
So, exceptions are rare but they're not unknown. There's widespread group support from a range of professional organizations. I'd be a fool to say everyone's supportive. So, for example, the consumer health group here in Victoria and the one in ACT do not support it but the National one does. And many of the state ones do.
Just to finish and my colleague Avi Rebera, will be talking a bit about some of the communications work and another information work the Minister has asked the government to support and is underway. But our role is actually to make sure that the implementation is smooth, to identify gaps and things keep on happening. So, for example, there's a few dentists here, but in general, we need to talk and work more with dental groups. So, gradually we're identifying groups that may have been left out. It was only and I hate to admit this, it was only probably a few months in, but we said we've really got to have information in different languages. Now, that should have been obvious to us at the beginning but it wasn't, so we're gradually identifying these gaps and doing something about them. And again, tonight might help you help us identify gaps.
New ways to disseminate information. I mean, everyone is blasted with information all the time, and so we not only want awareness of what the change is, because we don't want pharmacists to be harassed. We want people to plan ahead. If they feel they have a problem with recurring pain and they go to the doctor every 10 to 11 weeks to get my scripts refilled or for other things, we want them to think about that when they go there for whatever else they're going to the doctor for to start that discussion.
We're especially interested in chronic pain patients where we want consistent messages and also to particularly look at the impact on remote and rural Australia.
Wide representation in this implementation working group. I've mentioned a focus on rural and remote Australia, and part of the activities is, we're actually getting out there and getting involved and talking to people in remote and rural Australia. NPS national prescribing service medicine wise is targeting particular rural communities. We're working with a number of PHNs, and I'm delighted that we've got an upcoming speaker from one of the PHNs here west of Victoria. And we're also trying to target aged care facilities, Aboriginal health organisations and provide a source of information.
And here's our codeine hub and the URL for it.
So, I'm going to pass over to my colleague Avi Rebera who is a key person in this. When Avi took the job with us, we said you've got to manage this logistics, and one of the things you do is this medicine scheduling. And medicine scheduling has tended to be a fairly quiet area and non-controversial until codeine came along. So Avi has been front and centre of this, and Avi's going to talk briefly about some of the communication education activities.
As John said, my name's Avi Rebera, and for my sins, I have responsibility for scheduling in the poison standard. And no, John didn't tell me when I took the role that I'd have Codeine. So, I've slowly lost some hair as well through this process. I did have hair before this.
So, what I want to talk to you very briefly about today as John mentioned in his previous slides. There is a nationally coordinated communication strategy and education strategy that is run by the department, and like every good government agency, we have an acronym. So ? as John has mentioned, but on top of that, the government is also committing over a million dollars to provide additional communication and education activities through peak bodies. And over the next few months and even beyond 1 February, all of you will start to receive communication and opportunity for education programs through your relevant peak bodies and through your membership. So, what I'll do today is just very high-level run through what that is. I'm not going to go through all the details on these slides but they will be available, as John said outside, and they will also be available on the codeine information hub on the TGA website for you to go in and have a better read of all the information. And John's presentation will be on there as well.
So, broadly speaking as I said, the government is committing over a million dollars to provide support through certain peak bodies to provide education and communication materials. Some of you were asking when you came in whether you get CPD for tonight, points for tonight. You don't, but through some of these programs, it will be available as well. So, I'll run through them very quickly.
So, the first group is for GPs, and the support work that will be provided to GPs through the AMA and also RACGP and the College of Physicians. A lot of this work will actually be done by NPS Medicinewise for them, so you might see it coming out from NPS Medicinewise, but it is working very closely, and the messaging will be actually derived from these organizations and these peak groups. And the key thing around this is actually to provide information, education and also certain tools and materials for GPs, both the GPs to understand the implications of the changes, and the types of conversations to have, but there will be some material to hand out to patients as well. So, when those conversations are being had, especially around chronic pain and addiction, that GPs are actually able to have some tools and some material to be able to know what clinical pathways are, what pathways the patients will be taking, and the conversations that need to need to happen.
So, as John said, some of the consumer fact sheets, we're actually looking at how we do them in other languages as well. And so you'll see some of that coming out.
We'll also have a specific focus for rural health professionals, and this is quite an important aspect of the work that's happening, because while a lot of this will overlap with the material, and the material coming out for GPs can be used by rural health practitioners, we understand that some of the requirements and some of the challenges being faced in rural and remote communities is going to be different. So, what we'll see coming out from this is specific targeted information and support for rural health practitioners, and that's beyond GPs. That's also your nurse practitioners because there could be others that prescribe, not just GPs, so there will be targeted support that comes out, and this work will be done through ACCRAM, but also there's other groups they'll be working with as well. So, while we've got one key name in collaboration, they are all working together. We just have a lead agency or a lead peak body that will be running with this work as well.
So, there'll also be support provided and the guild will be working very closely with the PSA to provide targeted messaging and support for pharmacy owners, pharmacists and also pharmacy staff. And again, this is about enabling the pharmacists to be able to have conversations when people present. They won't be able to access their codeine over-the-counter product anymore. What are the conversations that support pharmacists need to have with those patients as they come in? And that will range from, how do I support the patient through chronic pain and potentially addiction? And what are the pathways that they need to take? Who do they need to be referred through? To conversations of identifying, well it's an acute pain issue, so how does that get managed at the pharmacy? And there'll be significant support provided to pharmacists through the guild and through PSA and the work that they're doing, and it'll be multi-channel.
Again, we've identified that while there'll be broader communications for the pharmacy sector, there is a special requirement for pharmacists working in hospitals, and so there'll be some work done through SHIPPA in in order to target that, and part of that will be what happens at the point of discharge when that pharmacist might be talking to that patient when they're leaving hospital, and conversations around acute pain versus chronic pain, and the support that they might need. And there could be additional materials that will be provided to that patient at that point in time. So, there'll be some targeted support there as well.
We're also going to be …the government's also going to be supporting consumer groups, and there are two main consumer groups that we'll be looking at work in this area. And the first one is is Pain Australia. So, Pain Australia will be setting up a communication and education program for their members and they've already done some work. I believe they had a workshop here in Melbourne last week to start that process in terms of that strategic workshop, and so they're going to be developing material, and this is now to actually communicate out to the broader community, and to consumers, and to patients around what support and what's available for them, not just in terms of how to manage chronic pain with medication, but other alternatives as well. And a lot of that will also be information that will be provided to GPs and other healthcare professionals to look at how, aside from medication, patients with chronic pain can be supported. And the important thing too is of also identifying people who are addicted.
So, that's work that Pain Australia will be doing. CHF will also be supporting Pain Australia in this, but on top of that, CHF will also be doing their own work in relation to getting information out to the community with regards to chronic pain, more specifically, but also the CHF will be looking at their own networks like the PHN networks to provide them with tools and material so that when they're having conversations with their staff, and also with patients, that the ability to have that consumer focus and understand what the patient and the consumer is thinking, and what they're going through will also be a key part of the communication in the education that's happening.
So, very quickly, and I've run through that very quickly that's what's happening. More broadly, from a communication perspective, a lot of you will start to receive material from these groups, so just so you're aware of it. The slides are available and if you need more information, happy to talk to you afterwards.
Thanks Avi. Well, we're going to have a… give you all your slides back. we're going to have a broader Q&A and discussion at the end, but at this stage, happy to take any questions clarifications or comments if you've got something in your mind at this stage.
Is the KPMG report available online?
Yes, it was published the day the decision was announced. So it's written in a dense style, sadly of health economists speak, but at the codeine hub on the TGA website, you'll not only find the KPMG report and the regulatory impact statement, and the regulatory impact statement is a bit easier to read than the KPMG report, but they both have data online, so yes it's public, it's part of a transparency thing in making any decision that has impacts on the population. This was the first time it was ever done for a scheduling decision, but for most other regulatory decisions, it's normal to do a regulatory impact statement. I don't mean to be crass about it, and politicians will call these winners and losers and to see whether overall there's a benefit or a negative impact on society.
Now it's a kind of a funny thing to do if you're doing something for public health safety reasons, and for that reason, this wasn't mandated on us, but we felt there's a lot of corridor whispering about the cost of a crushing of a health system. We saw headlines like that, so let's get a bunch of respected health economists to go and run the numbers, and I'm glad that we did it. But we didn't tell them what the answer had to be, I mean they they're professional independence is stronger than that but it's all up there on the website at that codeine hub. You'll see on the slides but if you just type in, Google TGA and codeine hub. All this will take you straight to the site.
Any other questions or comments at this stage?
It would be good to know who the audience is. How many are doctors…
If people don't mind, let's start. Who is a medical doctor in the audience? About 18 or so. Who is a pharmacist? Okay, the pharmacists outnumber the doctors, about 30. What other categories would we have folks? Who work in the health sector but not as a doctor or a pharmacist? Quite a few of us, I won't use the word hangers-on because we dominate. In fact, we hangers-on are pretty important so I guess the other people would be those who are working in support roles, those who have a policy role, those who may have other service delivery roles. And who would see themselves as a consumer rep? N equals one, the lone consumer.. we did invite consumer groups more broadly, but I am aware that both Pain Australia and consumer health forums work is very focused on the consumer group, and thank you for coming. Now, we all hate having names applied. Dentists, that's right. Yes, one, two, three. I knew there were three dentists and there are. Who have we forgotten?
Anyone from the media? That's good. This has been a very .. you wouldn't think with codeine, we're up to about 300 media articles in the last 18 months on codeine and it's absolutely amazing.
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