Medicines Shortages Including Ozempic Explained

Episode 9 May 22, 2023 00:24:07
Medicines Shortages Including Ozempic Explained
A WonderCare Podcast
Medicines Shortages Including Ozempic Explained

May 22 2023 | 00:24:07

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Hosted By

Sheena Mitchell

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A WonderCare Podcast
A WonderCare Podcast
Medicines Shortages Including Ozempic Explained
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Medicine Shortages Including Ozempic Explained

Medicine shortages are becoming more and more common. Here I explain why!

In This Episode:

  • Supply issues with medicines.
  • What this means on the ground for community Pharmacists.
  • A reflection on the patient impact now and the potential danger for the future.
  • How supply chains work in Ireland.
  • Government policy on medicines from The Health Act.
  • Proactive ways we can address medicine shortages.
  • Wejovy, Saxenda, Ozempic and Victoza supply issues.
  • Statements from Novo-Nordisk, HPRA, and Azure Pharmaceuticals.

Listen to the Ozempic Patient’s perspective here!

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Simply following and reviewing this podcast can make a huge difference!  If you enjoyed this episode ‘Medicines Shortages including Ozempic Explained’  I would be so grateful if you could follow or subscribe to the show! I aim to support family health and appreciate every one of you who take the time from your day to learn something new along with me!  We have episodes where I explain medical conditions and offer lots of tips and advice from my perspective as a Pharmacist mum.  We also chat with experts about a whole range of medical and family challenges. Of course I can’t forget our little voices episodes where I chat with kids and hear things from their point of view!  I’m also extremely grateful to everyone who contributes to a real lives episode – I learn so much from these and am privileged to be able to share your story which will help people who find them in a similar situation in life. You can check out all of my previous episodes by clicking right here!  
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Episode Transcript

Speaker 0 00:00:01 Hello and welcome to a Wonder Care podcast with me, Gina Mitchell. I'm a pharmacist and mom of three. This episode is a little bit different to my normal family health episodes. It's probably most suited for people who are concerned about medicine shortages, particularly Ozempic and Saxenda. It's also a good one to listen to for any healthcare professionals out there so that they can understand the challenges that community pharmacy are facing in terms of medicine shortages and the reality of the outlook going forward. If you prefer my regular health episodes, then don't worry. I'll be back on Wednesday continuing with my skincare season and I'll be talking all about psoriasis. Recently I recorded an episode relating to the shortages of ozempic and the impact that this was having on patients. In this episode. We heard from lots of patients and the distress and upset that the shortages we're having on them. Speaker 0 00:00:58 Today I hope to talk more about the supply issues and also other medicine shortages. I hope to explain what's actually going on in the supply chain and to follow up on my previous episode about the patient impact of the shortages in doing this, I also want to explain a community pharmacist perspective too. We cannot allow government policy or restrictions of medicine supply to damage the amazing and hard-earned relationship between patient and pharmacist. Sometimes we are all placed in a situation outside of our control, which makes everyone's life a little bit more difficult and a little bit more stressful. But I hope that with good communication we can overcome these hard times so that we can continue to work together to make you feel better and to improve public health. There are a lot of different angles to take in when you're thinking about supply chain issues. Speaker 0 00:01:48 There are a few different reasons that medicines can become difficult to source. One of them is being talked about broadly in the media at the moment because we have a much higher than ever before Medicine's shortage list on the H P R A website. A lot of that comes down to government policy on pricing, and I'll talk a bit more about that in a minute. Put ferrows and Ozempic, it's a very different situation. I think it's fair to call it the Kardashian effect. A huge global increase in the demand for drugs called GLP one analogs, which help to suppress appetite and help people to lose weight has caused a sea of demand for what was previously a market for only type two diabetic patients. Some examples of GLP one analogs that are on the market are ozempic and it contains semaglutide, as does Wago V, which is licensed in Ireland but has not yet been brought to market. Speaker 0 00:02:49 Then we have Victoza and Saxenda. So Victoza and Saxenda both contain liraglutide, but Victoza is licensed only for diabetic patients and Saxenda is licensed for obese patients. The marketing authorization holder for all of these medicines is Nova Nordisk, and at the moment it's been very widely reported that Ozempic is only available in very small quantities. Saxenda is in short supply and like gold dust wa Gavi is licensed but not yet marketed in Ireland and Victoza is also suffering from shortages. While trying to get to the bottom of this topic, I took a few steps. So the first one was to contact the H P R A. They kindly got back to me and said that Nova Nordisk, who's the marketing authorization holder, has notified the H P R A of intermittent supply issues with Ozempic products due to increased global demand. The company anticipates that intermittent supply will continue throughout 2023. Speaker 0 00:03:48 They say that similar supply constraints are being experienced by other EU countries, says that Nova Nordisk has implemented monthly allocations to help to ensure continuity of supply and actual distribution of Ozempic stock to patients. Nova Nordisk has also notified the H P R A of shortages of Saxenda. It says these also impact multiple EU countries. It's important to note that the H P R A publishes and maintains up-to-date list of medicine shortages impacting the Irish market, but notification of shortages and supply issues and information on resolution to this is meant to be reported by the marketing authorization holder to the H P R A, and that is how the H P R A list is formed. It's actually in European law that they're obliged to ensure that they notify the H P R A of shortages or potential potential shortages of supply of medicines in the Irish market. Speaker 0 00:04:46 As a pharmacist, I can tell you that this must not be happening because there are 241 medicines on the H P R A medicine shortages list at the moment, and there are over 350 which are actually on allocation from suppliers, which means that they do not have enough stock to meet demand. I'll explain this more in a minute. I also received a statement from ANOVA Nordisk spokesperson, and again, to be fair to them, they were very quick to get back to me, so I asked them the same questions pretty much as the H P R A. What is the story with the Ozempic supplies? So Nova Nordisk Ireland responded by saying that we continue to receive Ozempic supply into Ireland and we manage stock closely to ensure it is equitably distributed to patients. We're experiencing stronger than anticipated demand for ozempic, which is resulting in supply constraints and periodic shortages of various doses of the product. Speaker 0 00:05:46 Nova Nordisk faces the same supply issues affecting the broader pharmaceutical sector and wider economic activity. We are working hard to solve these challenges. When I then went back to them and asked them why wage AVI has a license, but that Nova Nordis haven't actually brought it into the Irish market, I wanted to know what the delay was and do they have an expected timeframe. The response from the Nova Nordis spokesperson was that Novo Nordisk has not confirmed a launch date for Wei Jovi in Ireland and we are working to make WEI Jovi available in Ireland as soon as possible. So that was all that I got from them. After a little bit more digging, I was able to find that Novan Nordisk had submitted we ovy for review with the N C P E. So these are the pharmacoeconomic people. They are in conversations about price and whether or not something will be reimbursed, et cetera. Speaker 0 00:06:45 A rapid review showed that it needs a full review. So I don't know how long these things normally take, but I am going to imagine that or suggest that we are going to be waiting for several more months before we see Wei Jovi on the Irish market. That is where the H P R A and the manufacturer tell us that we are. So we do know that some supplies are coming into the country as much as the distributor has allocated for Ireland. In any case, both Nova Nordisk and the H P R A stated that all European countries are receiving fair amounts on allocation. There was no mention of non-EU countries. I'd love to know that globally are Europe being undersupplied anyway. Once the stock gets into Ireland, then what happens to them? That's a difficult question for me to answer, but as background, it's important that you know that we have a difficult market in Ireland for pharmacy because there are actually only two wholesalers in the whole country that's United Drug and UniFi. Speaker 0 00:07:47 As pharmacy owners, we have to choose a preferred wholesaler for the bulk of our purchasing. This secures us better terms for things like frequency of delivery and Saturday delivery, et cetera. But if our primary wholesaler does not have stock of a medication that we need for our patient, we have to ask the second wholesaler for stock. It is my personal experience and the experience of many of my pharmacy colleagues that your secondary wholesaler will not provide you with stock of medicines which are in short supply. They have said that this is because they are not my primary wholesalers. This is becoming more and more of an issue with the medicine shortage is becoming more common and from a survey that I conducted recently of over 280 community pharmacists in Ireland, which represent pharmacies from every one of the 26 counties in Ireland, I can tell you that when asked if they'd experienced difficulties in obtaining supplies of ozempic for their patients, they rated the difficulty as a 90 out of a hundred community pharmacists also felt that there was an inequity in the supply chains between pharmacies located even in the same town. Speaker 0 00:08:59 57% of pharmacists felt that was the case and most relevant for this conversation, 85% of community pharmacists felt that their supply levels were being determined by their choice of primary wholesaler who suffers as a result of that. I ask and quite simply it's the patient. The patient in one area is not able to access medication, whereas a patient living in another is. It's also worth noting the community pharmacist spend on average five hours a month. So that's over an hour a week doing things like phoning the wholesalers, phoning other local pharmacies, contacting the prescriber, talking to the patient purely on supply issues for ozempic alone. So that is one medicine out of our whole dispensaries that is consuming so much time and then of course we heard from the patients in my last episode who felt like they were being discriminated against and I absolutely understand why they feel that way. Speaker 0 00:10:01 Unfortunately, we have been put in a position where we have to ask what clinical reason you are using ozempic four. So is it for diabetes or is it for weight loss? And community pharmacies are providing it for diabetic patients over weight loss patients in a lot of cases because diabetes is the actual licensed indication of the product, not weight loss. So this was also obvious from my survey where only 20% of pharmacists felt that they haven't been able to supply their diabetic patients with those pic, whereas 44% of pharmacists were unable to supply their weight loss patients. With those pic, we can see our patients becoming frustrated with us at the pharmacy counter, and this is a situation that is horrifying really because as community pharmacists we strive and work towards delivering patient care in the community. We're not choosing one group of patients over the other because of stigma. Speaker 0 00:11:07 We're choosing one group of patients over the other because of the licensing of the product. Ozempic is not the only medication that has supply issues. To provide a little bit of context this time last year there was somewhere in the region of 60 to 80 medicines on allocation from our wholesalers. Now there's over 350 medicines on allocation. So that means if I need 10 boxes a month for my 10 patients, I might only receive two. This is becoming increasingly difficult because what am I meant to say to the patients or how am I meant to prioritize patients who are suffering from a variety of different conditions? Because the shortages that are in place are not just relating to things like, like hay fever that was recently mentioned in one of the newspapers. It's actually to do with a huge range of antibiotics, a huge range of blood pressure medications and heart medications. Speaker 0 00:12:05 It's to do with anti-anxiety meds, medicines for I B S H R T, cholesterol medicines, epilepsy medicines, some fertility treatments, some arthritis medicines, breast cancer medication pain relief, eyedrops for glaucoma and eye infections, some nasal sprays and creams, and it affects so many different conditions. Media looking at the H P R A medicine shortage list, you know have one version of reality that is the shortages that have been reported to the H P R A, but as pharmacists working within the mechanism of allocated medications, like the reality is a whole lot more stark. So why is this happening? Why are so many medications across the board going into short supply? Azure Pharmaceuticals who compile the medicine shortages Index have said that manufacturers including Irish based companies, so domestic companies are getting paid up to four times as much for their products abroad than in Ireland. Speaker 0 00:13:17 According to them, the price we pay and a medicine pricing agreement that is no longer fit for purpose is at the heart of this issue. Manufacturers choose to maximize returns through supplying higher priced markets. Many manufacturers are actually discontinuing lines where there's no longer adequate profit. This means that instead of say there being three manufacturers and or suppliers of one blood pressure drug, it may be reduced to only two. If there's issues with those two upping their supply or they have any disruption to the flow of stock, suddenly then we're in a position where we have none on our shelves and it takes months for the market to recover. When reviewing a recent letter that I received in my pharmacy from the HSE telling me about further cuts happening as a result of the Health Act legislation signed in 2013 and I saw the list of drugs which were going to have the reimbursement price dropped once more. Speaker 0 00:14:16 It struck me that four of those medications are already on the medicines shortages list <laugh>. So we are telling suppliers who are trying to prioritize their distribution of limited stock to European countries and we are telling them to send it to us even though we'll pay them less, and actually there's probably additional shipping costs associated with that cuz we're not on mainland Europe, we're on the periphery and also reality check. We're a small fish of a country in a very big pond and it's time our government starts to see how irrelevant we are and if we want to make ourselves relevant, then bashing the manufacturers with a stick is not the best way to do it. Suppliers will continue to leave the Irish market. They'll either stop making lines altogether or they'll just pull them out of Ireland completely. I have a statement here from Azure Pharmaceuticals when I contacted them trying to get a bit more clarity on the situation. Speaker 0 00:15:20 I'll read it now. It is baffling that the Department of Health and HSE is not more exercised in trying to maintain uninterrupted supply of critical older medicines to the Irish market. No meaningful discussion has taken place with manufacturers applications for price increases for older unviable medicines go unanswered for months often until such a time as the manufacturer has made a decision to withdraw the medicine, maybe the department is happy not to have these medicines available to the Irish public. There is no other plausible reason to take risks with medicine procurement other than the belief that we as patients can do without these medicines. No one who is vested in keeping medicines available to Irish patients would take such risks with the supply chain by not seeking to understand the impact of the recent energy and input price increases has had on low priced medicines. We are talking about those medicines that are below the EU price average and that often costs cent per tablet. Speaker 0 00:16:18 Take the example of low dose aspirin, which is used as a blood thinner. A monthly supply is reimbursed at one Euro 3 cent, which is less than the cost of a bar of chocolate. That's the end of the statement, but it does make you wonder if they're fighting over a scent here or there. That is the difference between making a product viable or not for a manufacturer, and yet they're happy to waste so much money on useless administration processes and endless levels of bureaucracy within the hsc. It just makes you wonder where exactly their priorities are and it certainly doesn't seem to be on patient care. It appears to me that they would rather fall out with the drug companies to make a point than to provide patients with life-saving medicines. Obviously, Ozempic is on allocation for a different reason. It is as a relatively new drug profitable for the manufacturers. Speaker 0 00:17:13 However, thanks to the Kardashian effect, demand has vastly expended their expectations and the supply chain remains in turmoil while the manufacturer tries to ramp up production. This is having knock-on effect on Saxenda and Victoza and no doubt when we Jovi finally makes it to the market, a similar effect will apply. This episode isn't about debating the ethics of GLP one analogs. I discussed pros and cons of treatment with GLP one analogs extensively in the first episode, which you'll find if you flick back through my recent episodes on whatever streaming platform you're listening to this on is called ozempic the patient's perspective. Ultimately, it's time for us to be talking about how we value health, quality of life and prevention of more serious illness are really important factors. Think about it, if we don't pay for the expensive medications to treat obesity. Now in patients who are eligible, the majority of these patients will likely go on to develop type two diabetes, which will then require treatment. Speaker 0 00:18:16 Along with that, they'll have an increased risk of having high cholesterol, high blood pressure, cardiac disease, all of which we currently pay for honor drugs, payment scheme, and medical card systems. Now, so surely by introducing an additional cost of treating obesity, we're actually reducing the cost of treating its consequences in years to come. In addition to that, we're providing a quality of life to the patient, which is invaluable. I'm not saying that we can afford to pay for anyone who wants to lose weight to go on ozempic indefinitely, but for patients who are obese, who need support, who have tried dietary and lifestyle changes, or for patients who find themselves immobilized by their obesity, who are unable to go out and exercise in a proactive way to try and manage their health, weight and eating are hugely complex issues, often centered and focused around depression and other chronic diseases. Speaker 0 00:19:13 There should be no stigma attached to this conversation. We need to look at every individual patient's case we need to support our patients, and if that means an appropriate prescribing of GLP one analog, well then that's a worthwhile investment. Obviously, I do want to highlight that prescribing medication isn't a magical fix in a lot of cases. It can't be provided indefinitely and to enable that patient to successfully withdraw from their medication, they're going to need a lot of lifestyle and nutritional support and advice while they're on their treatment so that when it does eventually have to be withdrawn, they have the tools and capacity to manage their newer lighter body and to maintain its health. I'm not saying I have all the answers. All I'm saying is by not communicating with these patients, we're putting pharmacists in a position where they feel like they're involved in conflict, which is absolutely the opposite of what any community pharmacist wants, and ultimately we're making obese patients feel abandoned. Speaker 0 00:20:18 We're also creating this divide between diabetic and obese patients that's just wholly unnecessary. All of these patients are suffering with disease and all of these patients deserve the respect and clear communication on how these issues are going to be resolved. It's ozempic today, but it could very well be aspirin tomorrow by refusing to address the issue with medicine shortages and manufacturers. Our policy is failing us to do the right thing by our patient. As a healthcare professional, I think we need to be more proactive. I just hope that the policy makers can see sense. I really, really hate finishing an episode without a solution and whilst in the case of some medicine shortages, they're unavoidable, but for many it would appear to me that there is a potential to minimize the supply issues. Every time I speak about the pharmacy industry, it becomes more and more clear to me that we need a chief pharmaceutical officer within the Department of Health. Speaker 0 00:21:19 This needs to be a senior position and this person needs to be able to help the department to understand the reality on the ground. Similar to the chat of designing a minor ailment scheme without any pharmacist involvement, it just seems like driving a car with someone who never had any lessons, the HSE are driving blind. They need the input from an experienced pharmacist. I call for the recruitment of this position and I also call for everybody to keep raising this conversation on every platform they can, especially to their tds. This is a problem that is not going to go away and it needs to be addressed. Health is too important to adopt a head in the sand approach and just hope things get better with time. We cannot leave patients feeling fear for their health because their medicine is unavailable. Many of these medicines are critical for health. Speaker 0 00:22:17 There's always a lot of coverage about antimicrobial resistance, for example, and the fear with that is that antibiotics won't work when you need them most because of resistance issues. So why are the government not seeing that antibiotics won't work if we don't have them? Like off the top of my head, I can tell you that already primary antibiotics like ciprofloxacin, cefalo, doxycycline, co-amoxiclav, cephalexin, ch clarithromycin, azithromycin, and cefuroxime are all currently unavailable. If this is a crisis in the context of antimicrobial resistance, why is it not an emergency? Now we talk about antimicrobial resistance being the end of the world and we talk about it with fear and we take proactive plans to try to address it. Yet here when the nightmare has already landed on our doorstep, we fail to act. We cannot choose a commercial game of chicken over the health of the people of Ireland. I think we have no choice but to bring this conversation to the lap of the government and to ensure that they understand the changing landscape. I don't feel they're capable of doing that on their own. They have no pharmacist involvement. That's what I'm calling for today. Thank you for taking the time to listen to my concerns as a pharmacist and mom. I want better for our healthcare system and I want better for our patients who feel abandoned. Speaker 1 00:23:45 If you found the information in this podcast helpful, please do subscribe and follow where I'm sure <laugh> I'll be ranting a lot more in the future as well as continuing my plight to make healthcare more accessible to ensure that families are optimizing their health as best as they can. Thank you.

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