The Covid-19 shock led to shortages in essential drugs in many European countries, including France. According to the results of this survey, drug shortages for life preserving and life sustaining drugs such as anti-infectives and cancer drugs are frequent in Europe. Yes https://doi.org/10.1371/journal.pone.0119322.g003. Hospitalisations across Europe have been rapidly increasing, although in most countries still far below levels of the spring. Funding: KP is funded by the Agency for Innovation by Science and Technology (http://www.iwt.be/english/welcome). The median number of working hours to manage shortages estimated in this study is comparable to a survey carried out in the UK by the pharmacists’ organization Chemist+Druggist that previously showed that 95% of pharmacists spent between one and two hours per week on tracking out-of-stock drugs [14]. Analyzed the data: KP SS MC IH. Remdesivir and the steroid dexamethasone are the only drugs authorised in Europe to treat COVID-19. Surveys conducted in the US revealed that pharmacists often learn about the shortage at the moment they fail to receive an ordered product from the wholesaler or manufacturer (i.e. Press Release – PGEU Medicine Shortages Survey 2019 Results Each year PGEU conducts a survey among its membership to map the impact of medicine shortages across Europe from the community pharmacists’ perspective. In a survey by the American Hospital Association (AHA), anesthetics and also drugs for emergency care are more often reported to be affected by drug shortages than anti-infectives and cancer drugs [7]. While extensively studied in the US, drug shortages in European countries are yet little empirically investigated despite the fact that there are numerous reports that they frequently occur [11–15,23–25]. Such insufficiencies are not new in the global pharmaceutical market, which is … The authors are thankful to Thomas Bodvin for his contribution to the development of the survey. Similar results were obtained for most regions and countries even though a large part of the UK respondents indicated that cancer drugs were not affected by shortages (Fig. Mandatory notification in advance and centralized information can help to reduce workload for hospital pharmacists, will allow early anticipation of drug shortages and will facilitate mitigation of the clinical impact on patients. When a drug cannot be delivered at the moment of patient demand, every stakeholder in the health care system is affected. 2–3). Biosimilars and cancer drug shortages in Europe Posted 18/11/2011 With all the talk about drug shortages in the US it might be easy to forget the rest of the world, but it seems that drug shortages are also hitting European countries and are affecting not just generics, but also biosimilars. Secondly, some terms used in the questionnaire are not further defined to respondents and might be subjected to different interpretations. Respondents who indicated that particular types of medicines suffered more from shortages than others were considered. Data were analyzed anonymously. D. Answers to the question “What is the most affected form?”. Answers to the question “Are cancer drugs affected by drug shortages?”. An obligation to the producer to notify further shortages could help to solve the problem according to more than half of the respondents (57% indicated “strongly agree”, 4% indicated “don’t know”, 2% indicated “(strongly) disagree” and 37% provided no answer, n = 161) while 52% of respondents (strongly) disagreed to reduce quality requirements (9% indicated “don’t know”, 2% indicated “(strongly) agree” and 37% provided no answer, n = 161). Information provided by the government was never obtained according to a majority of respondents (40% indicated “rarely-never”, 16% indicated “sometimes”, 7% indicated “always-often” and 37% provided no answer). Available doses in the EU have so far been divided according to the number of cases and hospitalisation rates. In Poland, prices are on average 30% lower than in Germany [35]. Further, drug shortages in Europe are associated with a financial burden on hospitals, workload for the hospital pharmacy and clinical risks for patients. Germany’s health ministry said remdesivir stocks were sufficient for the coming months. European country) and completion of the first five questions of the survey. 2–3). Wrote the paper: KP SS MC IH. “Due to the increased hospital admissions, the demand for remdesivir is increasing rapidly,” the Dutch spokesman said. capacity problem) [12,16,29,30]. Parallel trade is likely to particularly affect shortages of the patented medicines due to high prices of such medicines and bigger financial incentives for the wholesalers. 2, 3 One of the most striking examples in recent years in Canada was the Sandoz crisis, which involved a production slowdown and shortages of hundreds of injectable drugs. Our study confirmed that the hospital itself is disadvantaged by drug shortages due to more expensive alternatives and additional hospital costs while patients remain free from financial burden. Also other hospitals provided information at the moment hospital pharmacists faced a drug shortage (30% indicated “at the time of no delivery”, 16% indicated “in advance”, 18% indicated “never” and 37% provided no answer, n = 161). The antiviral drug has been shown to shorten hospital recovery time in severe cases of COVID-19. The opinions with regard to rationing of the drug and delay of therapy were more diverse (Fig. Delayed treatment or switches to alternative therapies can result in disease progression, increased risk for adverse effects or medication errors and reduced compliance [4,5]. An inquiry into the characteristics of drug shortages showed that the typology of drug shortages differs between European regions and countries. 26 APR 2016. C. Answers to the question “Are these affected drugs mostly cheap or expensive?”. The financial impact of drug shortages where generic equivalent alternatives are available exceeds $78 million with the highest cost impacts coming from infectious diseases, surgery, oncology and cardiovascular diseases [1]. Drug Shortages in Europe is a non-profit project created for hospital pharmacists and other healthcare workers. Even more tragically, most 2011 shortages remain unresolved.” The article explained some of the causes of these shortages. Additionally, the clinical and financial impact, reported causes, measures to handle shortages, channels to obtain information about the drug shortage and possible solutions were questioned. Drug shortages for schizophrenia in Slovakia, where the drug price is set based on the second lowest price available in Europe, were also related to parallel trade [35–37]. Past EAHP Medicines Shortages Reports have highlighted the increasing burden of medicines shortages in European hospitals. Although respondents indicated information was provided by pharmaceutical companies and wholesalers, information was not provided in advance. No, Is the Subject Area "Pharmacists" applicable to this article? Yes Despite numerous articles appearing in the pharmaceutical trade magazines, facts and figures about drug shortages in Europe are rarely reported in the scientific literature [11–16]. Shortages in Europe mostly involved cheap generic and injectable drugs. 6). No, PLOS is a nonprofit 501(c)(3) corporation, #C2354500, based in San Francisco, California, US, https://doi.org/10.1371/journal.pone.0119322, https://www.premierinc.com/about/news/11-mar/drug-shortage-white-paper-3-28-11.pdf, http://www.ismp.org/newsletters/acutecare/articles/20100923.asp, http://girp.eu/files/7537b5f0-f4a6-11e2-80ff-a960bb6c1e24/Medicines%20shortages%20reflection%20paper%20including%20exec.%20summary%20FINAL.pdf, http://www.eahp.eu/practice-and-policy/medicines-shortages, http://www.ispe.org/drug-shortages-initiative, http://unstats.un.org/unsd/methods/m49/m49regin.htm, http://www.imshealth.com/portal/site/ims/menuitem.edb2b81823f67dab41d84b903208c22a/?vgnextoid=a6fbcc0f68f73310VgnVCM100000ed152ca2RCRD, http://static.correofarmaceutico.com/docs/2013/10/21/evaluation.pdf, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:134:0114:0240:en:PDF, http://www.knmp.nl/nieuws/belangenbehartiging/belangenbehartiging-2013/voorstel-knmp-voor-lage-medicijnprijzen, http://psnc.org.uk/dispensing-supply/supply-chain/branded-shortages/, http://healthcare.blogs.ihs.com/2012/10/09/parallel-exports-lead-to-drug-shortage-problems-in-the-heart-of-europe/, http://www.ihs.com/products/global-insight/industry-economic-report.aspx?id=1065983235, http://healthcare.blogs.ihs.com/2012/11/05/how-cost-containment-policies-impact-drug-prices-and-reimbursement-lists-in-cee-countries/. But not all EU states face shortages. The relative number of respondents per answer was shown for Europe (n = 161), Northern Europe (n = 55), Eastern Europe (n = 26), Southern Europe (n = 34), Western Europe (n = 46), the UK (n = 44), Belgium (n = 11) and the Netherlands (n = 16). For other possible causes, the answers were more diverse (Fig. On the financial level, increased hospital costs, increased pharmacy or personnel costs and the use of more expensive alternatives were indicated by a majority of respondents as consequences of drug shortages that occur always or often (Fig. Click through the PLOS taxonomy to find articles in your field. “Remdesivir has run out,” Dutch Health Ministry spokesman Martijn Janssen told Reuters, adding however that new deliveries were expected shortly. In European countries and regions, the typology of drug shortages is indeed heterogeneous. The susceptibility to drug shortages of generic injectables is sometimes linked to a lack of market attractiveness for generics [27,28]. n recent years, the prevalence of medicine shortages has increased in Europe. Parallel trade has become important in the UK since the low value of the pound motivates wholesalers to buy products at a low price in the UK and sell them in high price countries such as Sweden and Germany [13,34]. Last year, a record of 267 drug shortages were reported, up from 58 in 2004. According to Fig. The supplies secured so far by the EU were supposed to cover needs until the end of September. Therefore the aim of this study was to further investigate the characteristics, impact, causes and management of drug shortages in European hospital pharmacies and identify opportunities for prevention and mitigation of drug shortages in Europe. The respondents were asked to estimate time spent per week (number of hours) on the management of drug shortages. Drug shortage problem needs to be tackled internationally. [Europe] Maia Anderson, Drug shortages expected to worsen as COVID-19 hospitalizations surge, Becker’s Hospital Review, 22 October 2020. Conceived and designed the experiments: KP SS MC IH. 1). According to other studies, nurses sense ignorance when they are not aware which alternative medications to consider and when they are unfamiliar with dosing and administration of alternative drugs in case of shortages [6,8]. Only descriptive statistics were performed. Welcome to Drug Shortages Canada, the website for reporting drug shortages and discontinuations in Canada. Thirty seven percent of respondents did not answer this question (n = 161). It has now enough doses to meet needs for the coming weeks, the health ministry said on Tuesday. For Figs. Contributed reagents/materials/analysis tools: KP SS MC IH. 29 JAN 2015. Based on our results, opportunities for better prevention and mitigation of drugs shortages in Europe could be identified. The research was carried out independently by KU Leuven and the final manuscript was approved by TEVA. This study explores the phenomenon of drug shortages based on experiences of hospital pharmacists in a broad set of European countries. Hospital pharmacists presented manufacturing problems as the most important cause of drug shortages. The answer “always” and “often” as well as “never” and “rarely” were grouped for the sake of clarity. But when the European Medicines Agency reported in early April 2020 that several EU member states were close to running out of medicines to treat COVID-19 infections, the discussion on drug shortages gained additional momentum. The origins of drug shortages are complex and diverse and the problem can be situated at both the supply and demand side [1,2]. After a patent holder has placed its products on the market, his intellectual property rights are exhausted and (cross border) trade with the product is allowed and can cause unforeseen export consequently leading to drug shortages [33]. The European Medicines Agency (EMA) recently released a proposal for how it can help mitigate potential and real drug shortages stemming from manufacturing problems, reported FiercePharmaManufacturing . parallel trade) in the cause of drug shortages was suggested. C. Answers to the question “Are these affected drugs mostly cheap or expensive?”. B. Further, the possible impact of cost-containment policies, such as tendering, on the availability of drugs needs to be considered and applied with respect to the sustainability of the market. As a result, clinical effects of drug shortages can be reduced. NHS faces drug shortages as Brexit stockpile used in Covid crisis. An analysis was also performed for Belgium (n = 11), the Netherlands (n = 16) and United Kingdom (UK) (n = 44). A drug shortage can be defined as a shortcoming in the supply of a medicinal product that affects the patient’s ability to access the required treatment in due time. Its mission is to collect, analyse and share information about ongoing drug shortages in Europe. B-D, respondents who indicated the disease domain is affected were considered. Currently, shortages.eu is focused on the European Economic Area. This is particularly important with regard to causes of drug shortages as the term manufacturing problems may cover problems with economic root causes such as tendering. No, Is the Subject Area "Drug prices" applicable to this article? In July alone, cancer patients were unable to access treatment in Italy, shortages of neurological drugs reached an “ unprecedented scale ” in Poland and the total number of unavailable drugs in Belgium reached a new record. 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