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Webinar recording: Medicine shortages reporting reforms, 28 November 2018

What you need to know

11 December 2018

Disclaimer

This recording is provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the recording should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the recording.

Recording of online webinar

  • Webinar date: 28 November 2018
  • Webinar summary: This webinar was aimed at helping sponsors to understand the new requirements, including information about reporting medicine shortages and management and communication of medicine shortages.

Transcript

Rachael: Introduce you today to our speakers, we have Avinash who is a pharmacist who has worked in different fields in the health sector, including practising as a hospital and retail pharmacist in the pharmaceutical industry and most recently at the TGA. Jocelyn comes from a hospital pharmacy background and has worked at the TGA for many years, where she has held a variety of roles. Without further ado I'm just going to pass the time over to them and we will hope you enjoy today. Thank you.

Ms McDonald: Hello, my name's Jocelyn McDonald, I'm the Assistant Director of the Medicine Shortages Section, many of you will know who I am. I manage a small team of two other pharmacists who also assist with Medicine Shortages, Anna and Shane, and I'll be one of your presenters today.

Mr Vazirani: Hi, I'm Avinash Vazirani, apologies for the technical difficulties here, technology is not always perfect, so we do appreciate you bearing with us and being patient. As Rachael said, I'm a pharmacist by background and with respect to the Medicine Shortages Reforms I am the Project Manager that has oversight of all the work streams related to the reforms. I, without further ado, will hope to proceed, just bear with me. Rachael has gone through housekeeping and just some website and link references to some of the more important documentation relevant to this presentation and to mandatory reporting. If you wanted to find further information on these items, you can click on the following links. We will reference these throughout the presentation and I think it's important to note that this presentation will cover the key concepts and we do have examples laid out throughout the presentation to help reinforce some of the key concepts that are discussed. Jocelyn and I will both take turns to go through some of those concepts, so let's get right into it. I guess first things first, what is a medicine shortage? As it says there, "There is a shortage of a medicine in Australia at a particular time if at any time in the six months after that particular time, the supply of that medicine in Australia will not or will not be likely to meet the demand for the medicine for all patients in Australia who take or who may need to take the medicine". Now, that's quite a mouthful, that is the legal definition that is in the Therapeutic Goods Act and I just wanted to take a moment to explain some of the key words within that to help sponsors extrapolate and I guess understand that a bit better. "At a particular time, if at any time in the six months after that particular time", refers to the instance in which we expect medicine sponsors to have knowledge or to report about current shortages or anticipated shortages that they'd expect to occur within the next six months from that point in time. This is to ensure that there isn't an unrealistic expectation on medicine sponsors to be aware of shortages that may occur in two, three, four, five years' time. The second point, "all patients in Australia", second phrase, refers to making it explicitly clear that the definition of a medicine shortage is met if supply or lack of supply affects everyone at a national scale as opposed to local instances of stock outs, which we'll get into and explain further later on in today's presentation.

Ms McDonald: What is a discontinuation? A discontinuation is an instance in which the medicine sponsor has decided to permanently cease supply of the reportable medicine in Australia. Depending on the nature of the impact of the discontinuation, different reporting timeframes will apply. The TGA acknowledges that there can be many reasons why a medicine sponsor may decide to discontinue a medicine. For example, a commercial decision taken by the company or a medicine that has fallen out of favour because of a new, more efficacious treatment or following a recall. I'll go into the specific legislated timeframes which apply to discontinuations which will speak to the different patient impact levels later on, but I want to make it clear that a discontinuation is different from a cancellation. A sponsor can discontinue a product, but keep the product registered on the ARTG. A medicine shortage notification is required for a discontinuation, even though the product remains registered. Of course, if the product is to be cancelled, the sponsor should submit a Medicine Shortages Notification advising of the discontinuation prior to the cancellation.

Mr Vazirani: Now, we come to what medicines are subject to the requirements of the new scheme and there is the term 'reportable medicines', which is the legal definition of every medicine that will be subject to mandatory reporting. This includes all prescription medicines, including Schedule 4 and Schedule 8 medicines, as well as a select few over the counter medicines, which I'll get to in a moment. These are contained within a legislative instrument which is called the Reportable Medicines Determination. Now, it's important to note also that irrespective of the PBS status of a medicine, if it is still considered to be a reportable medicine as per the definitions I've just outlined, it still will be subject to the reporting requirements of the new scheme. What is the Reportable Medicines Determination? As I mentioned, that's another way of saying a list which contains the specific over the counter reportable medicines that will be subject to the requirements of the new scheme. There are 11 medicines on this list and, very quickly, these include adrenaline autoinjector, Glucagon injection, glyceryl trinitrate sublingual, levonorgestrel, monobasic sodium phosphate, Naloxone injection and nasal spray, salbutamol Autohaler and inhaler, the Terbutaline inhaler and Ulipristal. Now, these medicines have been included and are subject to these requirements within the new scheme as per the criteria that's set out in the legislation and this criteria takes into consideration factors such as whether the medicine is critical to the health of patients in Australia and whether the notification of any shortage of the medicine or of any decision to permanently discontinue the supply of that medicine in Australia would be in the interest of public health. Now, it's important to note that the lists of these over the counter medicines which are subject to the new scheme will be reviewed and may be amended in consultation on an annual basis and it is the Minister's discretion to include or remove medicines from the list. Although, in practise, that would happen most likely by delegate of the Minister, which would be an executive officer within the TGA.

Ms McDonald: The other list that we have is the Medicines Watch List, which again is a subset of reportable medicines. It's a list of the ingredients that when contained in a medicine would deem a shortage of that medicine to be of critical patient impact. There is 97 prescription and over the counter medicine ingredients at the moment on that list. The creation of the Medicines Watch List was designed to provide certainty to sponsors and the public in relation to reporting obligations for shortages and discontinuations of medicines that have ingredients included on the list. Any medicine that contains an ingredient on this list which meets the definition of a medicine shortage will automatically be taken to be of critical impact and critical impact medicine shortages have different reporting timeframes associated with them, compared to medium and low impact shortages. The criteria for critical impact is either the ingredient is on the Medicines Watch List or there is no other registered goods that could reasonably be used as a substitute or are not likely to be available in sufficient quantities to meet demand and has the potential to have life threatening impact. It's important to note that a shortage of a medicine not on the Medicines Watch List could still be a shortage of critical impact and therefore, subject to the shorter reporting timeframe. The guidance sets out the criteria for the sponsor and TGA, the criteria that the sponsor and the TGA both use to assess the impact of the shortage. Whether the shortage or discontinuation of the medicine has the potential to result in significant morbidity in patients in Australia or the death of one or more patients is the criteria used to include things on the Watch List. Much the same as the Reportable Medicines List, the Medicines Watch List will be reviewed and amended in consultation on an annual basis. The TGA will undertake appropriate consultation with stakeholders before adding medicines to or removing medicines from the Watch List. There may be situations which will warrant an episodic review of the Medicines Watch List and the decision to convene this would be at the discretion of the Chief Medical Advisor or a delegate of the Minister. The Medicines Watch List is publicly available on the Federal Register of Legislation, which can be accessed at the website on our links page and it'll be available by the end of the year. You'll find it's also contained in the regulatory guidance document that was published on the website last week and there's also a link to the regulatory guidance document on the links page in this presentation.

Mr Vazirani: Thank you, Jocelyn. Moving on, so we're just going to take a look at patient impact and Jocelyn mentioned about critical impact medicines, so I won't labour too much on this slide. I will inform everyone that this pictorial has been taken out from the regulatory guidance, which is available on the website as Jocelyn mentioned, but I just very quickly wanted to cover the sorts of parameters that medicine sponsors are expected to take into consideration when making their determination of impact assessment. The parameters that we stress sponsors consider in their assessment include the nature of the therapeutic alternatives that are available, should they be available in the time of the medicine shortage, and the percentage and number of population affected and, inherently, the number of patients that take a medicine that is in shortage. As you can see, there is a direct correlation between whether there is an exact alternative available from the similar all the way to no alternative and what bearing in terms of impact that would have on the medicine shortage. Obviously, for a medicine which had no alternative available and whether it affected a large or smaller number of the population, it would deem to be of critical impact. The next slide will cover some of the definitions of what we mean by exact/similar/appropriate/possible and none. I'll just highlight that sponsors should familiarise themselves with these two slides within the regulatory guidance, as well as familiarising themselves with the medicines included on the Medicines Watch List, as that will give and allow sponsors to determine whether they have a critical, a medium or low impact patient impact medicine shortage and subsequently, will allow them to determine what reporting timeframes they need to adhere to as will be mentioned very shortly by Jocelyn.

Ms McDonald: We've talked about reporting timeframes, what are the new mandatory reporting timeframes? For a shortage of critical impact we would need to report as soon as possible, but no later than two working days after the sponsor knows or ought to have reasonably known of the shortage. For any other shortage, so that is a medium impact or a low impact shortage, the sponsor has up to ten working days after the sponsor knows or ought to have reasonably known of the shortage to submit the notification. For discontinuations of critical impact, at least twelve months before the discontinuation would occur or if this is not possible, as soon as practicable after the sponsor's decision to discontinue the medicine. And for any other discontinuation, so again low or medium impact discontinuations, at least six months before the discontinuation would occur or if not possible, as soon as practicable after the decision. Now, the TGA acknowledges that sponsors in some instances may not have all the required information about a critical impact shortage to submit to TGA within the two-day timeframe. Therefore sponsors, to comply with their legislative obligations they must report a minimum mandatory required information within the first two days of knowing of the shortage and this information is set out in the new online notification form. If the sponsor does this, they will then receive correspondence in the form of a Section 31 notice from the Medicine Shortages Section requiring the remainder of the information on the form to be submitted by the date provided in the Section 31 notice. That date will be five working days after the date that the sponsor first knew of their shortage. Submitting the completed notification by the due date will be considered the sponsor's response to the Section 31 notice and fulfilment of their reporting obligation. For any other shortage or discontinuation, that's low and medium impact shortages and discontinuations, all information is required to be provided in the first Medicine Shortages Notification reported to the TGA.

Mr Vazirani: Just to surmise before you go on, Jocelyn, there's obviously a tiered approach to reporting a critical shortage and a minimum mandatory amount that you will cover right now, but with any other shortage or discontinuation all information is required to be reported in the first instance within the timeframe, is that correct?

Ms McDonald: That's correct, but if the sponsor has all the information for a critical impact notification they can supply that within the first two days.

Mr Vazirani: Okay, thank you. Sorry.

Ms McDonald: What information needs to be reported? All medicine shortages and discontinuations are to be reported in the TGA eBusiness Services portal. For critical impact notifications, there is a minimum amount of information that's required and the minimum information required is the impact of the shortage and the nature of the shortage. These will be asked for initially and they will determine how the form acts. The sponsor name, which will be now autopopulated based on the person who logs into eBS, the sponsor address, the Australian telephone number for public contact purposes, the medical information email for public contact purposes and the ARTG number, which will provide the ARTG name and the shortage. Just before I go on, sponsors who wish to submit a medicine shortage notification must ensure they have a TGA eBusiness Services account and a personal login and if that is not the case they should contact the TGA helpdesk for assistance in setting one up. The other information that we require in an initial report is the primary contact, again this is autopopulated based on the person who logs into eBS. The date the shortage was known to the sponsor, estimated date for the start and end of the shortage or the deletion from market date if it's for a discontinuation. The availability of the product and the proposed date of publication on the TGA website. Now, the online notification form has other fields which are not required if you're submitting the minimum mandatory information, these include information about the sponsor's market share, quantities on hand, the global nature of the shortage, communication activities and what supply management actions the sponsor may have undertaken. Letters to stakeholders can also be attached to the notification form or submission to TGA. Critical impact shortages and discontinuations will be mandatorily published on the TGA website and the sponsor is requested to elect a publication date, however the TGA does have the ability to publish if necessary. While it's not mandatory to publish medium and low impact shortages on the TGA website, publishing is encouraged to provide timely advice to healthcare professionals and to enable them to make alternative arrangements when necessary.

Mr Vazirani: We're just going to go through the first example today, so Jocelyn, can you please introduce this scenario?

Ms McDonald: Natural disasters have been known to significantly affect the availability of medicines. In this scenario, on 15 November a sponsor becomes aware that a typhoon has affected the manufacturing plant in Japan. On 20 November, after investigating further and obtaining information from the manufacturer, the sponsor concludes that although the stocks of the medicine in Australia will be sufficient to meet demand for the time being the damage has resulted in manufacturing delays, so by mid-December will result in the supply of the medicine not being able to meet demand.

Mr Vazirani: Sorry, we've just been informed that our slides are running a bit slow, so apologies for that, but I hope everyone can see the outcome page of Example 1. As the anticipated shortfall of supply falls within six months of 20 November 2019, on that date there is a reportable shortage of the medicine. In this instance, as the medicine has no generic substitute or any alternative available, the shortage is deemed to be of critical impact and the sponsor therefore must notify the TGA as soon as possible or within two working days, and in this particular instance that would be by 22 November 2019. Just want to recap this example, if I go back to the scenario on 15 November there was news of a manufacturing plant potentially being affected, in this instance the sponsor did some further investigation as soon as they heard about that and confirmed by 20 November that they in this instance had a medicine shortage that would be occurring and from 20 November had two working days to report that medicine shortage, because in this instance it was deemed to be a critical medicine shortage. I hope that is clear and we'll carry on. Now, we're just going to cover in the next few slides what are the roles of the different stakeholders that are involved during a medicine shortage or discontinuation, starting with the role of the sponsor. Obviously, the sponsor has the key regulatory obligation in this instance and the onus is on the sponsor to maintain continuity of supply of the medicine that they're supplying in the Australian market. And that would include sponsors participating in demand forecasting to ensure supply is adequate as well as maintenance of safety level stocks, as well as the TGA would assume under the new requirements contingency planning to reduce disruptions. Should all of that fail and unfortunately a sponsor finds that in their particular instance, after striving to ensure continuity, they still have a medicine shortage as per the definition, they would then have to report that medicine shortage. The sponsors would be obliged to report under the necessary conditions depending on the impact status of the shortage, as was outlined by Jocelyn, with the relevant information. Sponsors would also be expected to implement management activities as well as communication activities that would be appropriate. This would include the publication of medicine shortages, putting out communiques on their websites including activating and promoting information hotlines should that be necessary, as well as contacting healthcare professionals and other stakeholders that are required to be contacted directly. We would assume from the new year going forward that sponsors will be adopting processes within their respective companies into business as usual activities on an ongoing basis to ensure that they continued to be compliant with the requirements of the new scheme. We'll be covering a second example now and Jocelyn will be introducing this example.

Ms McDonald: In this scenario we're going to discuss a discontinuation of a medicine. For example, commercial reasons create a medicine shortage that may be subject to mandatory reporting. In March, the global parent company decides to shut down Australian operations and subsequently ceases supply in the Australian market from October 2019. The medicine sponsor has three items registered on the Australian Register of Therapeutic Goods which will all be discontinued in seven months' time.

Mr Vazirani: In this particular case, the discontinuation will result in a shortage as being assessed as low patient impact, because for the purposes of this example there are many generic equivalents available for this medicine. As such, the sponsor is required to report the discontinuation to the TGA at least six months before it is proposed to take effect or as soon as practicable if that is not possible. If the medicine had been on the Medicines Watch List or the shortage was assessed as being critical it should be reported, again as soon as possible and at least twelve months in advance, whichever is deemed to be more plausible in that particular case. The sponsor should begin the preparation of correspondence to relevant stakeholders to be included in their notification to the TGA. It's interesting to note that in this particular scenario the sponsor is actually not legally required to advise the TGA immediately as the discontinuation is in seven months' time and this is a low patient impact discontinuation. However, early notification would be encouraged as this gives health professionals and consumers and all stakeholders required more time to consider their options in this particular scenario. Moving on now to what is the role of the TGA during a medicine shortage and discontinuation, Jocelyn?

Ms McDonald: The role of TGA is not to be the sole manager of the shortage, even though medicine sponsors will have a regulatory obligation to report under the new scheme, the management of medicine shortages should be a joint effort between all stakeholders involved. The shortage or the discontinuation must be notified to the TGA once it's been confirmed by the sponsor, TGA will then confirm and verify the impact assessment. The TGA will conduct quick touch reviews when they're required with internal medical officers as per the response plan in the guidance document to look at the impact assessment and the options for management. The TGA will also undertake proactive management actions, publish critical medicine shortages on the TGA website. For critical impact medicines, where necessary, the TGA can convene a Medicine Shortage Action Group for medicines that have a critical impact and this involves seeking advice from external specialist medical officers and external specialist pharmacists in the field related to the use of the medicine, along with the Medicine Shortages Section and the sponsor. TGA also can approve temporary supply of the medicine or therapeutic alternative, undertake additional communication activities, if required, and liaise with other stakeholders where required, including the Medicine Shortages Action Working Group. The participants in the group will depend on the product that's in shortage. Unlike a committee, the participants of this group are not fixed. The external specialists and the sponsor will change with each shortage. TGA also have an active role in approving the use of Section 19a products and Section 19a is the ability to facilitate the availability of an unapproved medicine in place of a registered medicine that is unavailable or in short supply. I did say that publication of critical medicine shortages on the TGA website will be mandatory, but again we do encourage the publication of low and medium impact shortages on the website as well.

Mr Vazirani: Now, coming to the role of healthcare professionals during a medicine shortage and discontinuation. At the TGA, we appreciate that doctors, general practitioners, pharmacists, healthcare professionals that engage directly with patients and consumers of medicines are ultimately on the front line and on the coal face, if you like. We would encourage and expect them to continue counselling and educating consumers in times of a medicine shortage. And I think this reinforces the point that a lot of healthcare professionals, apart from receiving communications from sponsors, do also check the TGA website and refer to the Medicine Shortages Information Initiative component of the website which will include a list of all of the shortages. We do encourage sponsors to ensure their communication activities are robust and timely and do encourage those sponsors, particularly of low and medium patient impact shortages, to publish this information. We also acknowledge that during a medicine shortage healthcare professionals are involved in identifying alternative treatments for patients, where required, and there's ongoing intercollaboration between prescribers and dispensers. That proactive identification of alternative management actions and coupled with the communication activities between sponsors and the TGA is very important for achieving the end result. Which is ensuring consumers are aware of what they need to do during a time of a medicine shortage.

Ms McDonald: I just want to touch on local stock out issues, so when it's not a medicine shortage. There may be instances in which a select population of individuals in Australia may not be able to access a certain medicine at a particular point in time. This could be due to a number of reasons, including limitations in delivering to a particular region. For example, a town in which only a pharmacy depot exists or due to specialised commercial arrangements between wholesalers and pharmacies. Local stock out issues also extend to unavailability due to areas being cut off by floodwaters, where stock is normally transported by road. It should be noted that unless these situations were to be universal in nature and affect all patients in Australia, in accordance with the definition, they would not constitute a medicine shortage. Situations like these where all patients in Australia, which is part of the medicine shortage definition is not met do not constitute a medicine shortage and I think we have an example in the next slide.

Mr Vazirani: It's very relevant to the weather today in Sydney as well, I'm sure. Just introducing the next example to further reinforce this point, Jocelyn, can you please introduce this example?

Ms McDonald: We have a rural town in Victoria that has only one pharmacy servicing it and due to the pharmacy being a relatively small business compared to its regional and metropolitan counterparts and the volumes of business conducted, it doesn't have commercial arrangements with all of the major available suppliers. During a shortage there is an alternative product through another supplier, this pharmacy doesn't have a commercial agreement in place or any capacity to order stock from that supplier. As a result, patients in this population have to either drive to another town or visit a pharmacy to get their prescription for the product filled.

Mr Vazirani: Just moving onto the outcome of that scenario, in this particular instance because this would represent an unavailability of a medicine at a particular location and not affect all patients in Australia, it would ultimately not constitute a medicine shortage as per the definition in the Act. No regulatory obligations in this particular instance would be imposed on the medicine sponsor and they would not be required to report this. I think we're coming up towards the end of our presentation. Now, as is the case with any mandatory scheme, to ensure compliance is met there has to be a number of tools available. With the new mandatory reporting scheme there are measures that are already in place as well as that have been introduced to help ensure that medicine sponsors comply with their regulatory obligations in accordance with the TGA's Regulatory Compliance Framework. The TGA will be taking a graduated approach to ensuring compliance is met and we are endeavouring to embark on a suite of education and training activities, as well as communication activities, to ensure sponsors are able to meet and be aware of their regulatory obligations. Such as activities today with the webinar, publication of online materials and guidance and in the future, the potential for there to be face to face workshops and other modalities. We want to promote this and ensure sponsors are aware of what it is they need to do. That's the first tier and what we would encourage in the first instance, but there are also new regulatory measures available under the Act that have been introduced to address breaches and, in particular, acts of deliberate noncompliance. There are a couple of options available to the TGA to penalise those medicine sponsors which have been noncompliant and this would include measures such as the publication of the details of sponsors and the medicine shortages which have not been reported on the TGA website to the issuing of infringement notices directly to medicine sponsors all the way to the greater end of the spectrum, which would be the initiation of civil penalty proceedings which would practically result in the issuing of large fines. That's obviously a space we don't hope to find ourselves in and by giving today's presentation along with other activities, we hope sponsors will continue to educate themselves and remain compliant under the new scheme. I think we have come to the end of our presentation, sorry. There's more information available on the TGA website, which you can see on the page there. The Medicine Shortages Guide has been published, as mentioned, and there's also information which will be pushed out through our social media channels on Facebook and Twitter. And we will endeavour to have a video available on YouTube in the new year. That's amused my co-host. Thank you to everyone for tuning in and we do sincerely apologise for the technical issues at the beginning. We're now just going to look at some of the questions that have come through. One question is, "What about devices? They can be affected", that's what's been asked of us. I'm going to extrapolate that to assume the question is are medical devices required to be reported and the answer is, no. Medical devices are not subject to the requirements of the new scheme, they will not be considered a reportable medicine and will not be required to be reported to the TGA under this scheme. That's the first question. Another question that has come in, "How do we assess if there are appropriate alternatives/substitutes available if we don't know whether the other suppliers can meet the market need?" That's a really good question.

Ms McDonald: I'll take that.

Mr Vazirani: I'll hand that to Jocelyn.

Ms McDonald: I think it's important for the sponsor of a person who has the shortage to notify early and let us know. If they are unable to determine that information themselves, just by letting us know about the shortage and submitting the notification we can then reach out to other sponsors of registered products that are available in the market and gauge the amount of availability and whether those sponsors can meet the market demand.

Mr Vazirani: Yeah, that's right. I think it's important to note that there is an expectation that medicine sponsors are only required to be aware of their particular situation and their supply level at that point in time, we don't expect sponsors to have an exact understanding of what the levels are of other sponsors. But inherently we do appreciate that there may be situations whereby a sponsor of a particular product has gone into a shortage and there may be another sponsor who makes the same medicine, and due to the initial product having gone into shortage there may be an unprecedented demand. I think in those instances sponsors need to just have a look and maintain and evaluate what their stock levels are at any given point in time and if they do find that they do run into a medicine shortage, irrespective of the cause, if their situation meets the definition they will have to report that to the TGA.

Ms McDonald: I can see another question, "What happens if you apply for a Section 14 to cover the shortage, but you're still waiting on a response of the evaluation two months later?". If you are going to apply for a Section 14 because of the shortage please tell us in your Medicine Shortage Notification. And if you know the submission number for your Section 14, you can include that in the supply management actions, there's a free text box in the form where you can include that information. Then, we internally can contact the Pharmaceutical Chemistry Section and let them know if there is a shortage of that medicine that's been clinically approved by the Clinical Units, that we do need that notification or that submission expedited and they will bring it to the top of their queue and process it as quickly as possible. We have got that process in place at the moment and that will continue to be in the new system as well.

Mr Vazirani: Okay, I think we've only got time for one more question, someone's asked if there is an education campaign for doctors, dentists and pharmacists. Absolutely, doctors, dentists and pharmacists, as mentioned, are critically important stakeholders during a time of a medicine shortage and we definitely will be endeavouring to publish some targeted materials towards healthcare professionals. They will be published within the next month or so, very soon before the launch and implementation of the new scheme. I would encourage all of you online today to look out for those materials on the TGA website, as well as following Twitter and Facebook as those updates will be made on those respective pages as well.

Ms McDonald: Okay and there's one more question here, "How will TGA ensure pharmacists are aware of the site from their experience trying to access a product out of stock?", they're unaware currently. I think we're going to reach out to the Pharmaceutical Society and the Society of Hospital Pharmacists.

Mr Vazirani: Yeah, targeted information is being sent to a lot of the peak organisations that Jocelyn mentioned, we'd also encourage pharmacists to subscribe to the Medicine Shortages alert service, which is on the TGA website and RSS feed, as that is a weekly update which gets emailed to you on the latest medicine shortages which have occurred. My strong encouragement would be for those people, in particular pharmacists, to be subscribed to that service, to continually peruse the TGA website and Medicine Shortages Information Initiative and to look out more broadly on the TGA website for new materials that are available. I can appreciate that, in particular for pharmacists working in retail as I have once done in a former life, it can be quite frustrating to not hear about these things, but we're hoping under the new scheme and with the communication activities, pharmacists and doctors and healthcare professionals will be more aware of medicine shortages.