Welcome to Drug Shortages Canada, the website for reporting drug shortages and discontinuations in Canada. Britain, which has joined the EU procurement for remdesivir, has rationed its supply, prioritising COVID-19 patients who need it most, the health ministry said. In Poland, prices are on average 30% lower than in Germany [35]. 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. Affiliation A majority of respondents believed that manufacturing problems were always or often the cause of drug shortages (Fig. Further, drug shortages in Europe were associated with a clinical and financial burden and additional workload for the hospital pharmacy. 1). tendering) and trade of pharmaceuticals (e.g. The authors are thankful to Thomas Bodvin for his contribution to the development of the survey. An inquiry of United States (US) health care workers showed that in up to 99% of surveyed hospitals, drug shortages were experienced in the months preceding that study [6–8]. Gilead has expanded its production capacity. Firstly, as this study assumes drug shortages can be influenced by national policies, the regions considered in this study can be too broad to detect country-dependent effects. 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. While dexamethasone, a generic medicine, is widely available and cheap, remdesivir is protected by Gilead’s patent. For Figs. The government was limitedly involved in the management of a shortage. 1 Numerous signs point to the growing importance of this issue, particularly in Europe and North America. The causes of shortages are multifactorial and fall within three main categories, namely economic, manufacturing and regulatory causes. Data were analyzed anonymously. 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. No, Is the Subject Area "Pharmacists" applicable to this article? The relative number of respondents per answer was shown (n = 161). 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]. Too high prices, too many competitors, the economic crisis and high quality requirements from authorities were rarely or never the cause of drug shortages according to a large share of respondents (Fig. For example, immunological products involve a large amount of biologically active ingredients which are unique and cannot be included in tendering. The total number of new and ongoing shortages crossed the 450 mark in 2012 (1). [Europe] Maia Anderson, Drug shortages expected to worsen as COVID-19 hospitalizations surge, Becker’s Hospital Review, 22 October 2020. From then on, a link to the survey was announced in the weekly online bulletin of HPE, sent to 7,000 subscribers. EMA shortages catalogue National registers European Medicines Agency (EMA) publishes … Respondents who indicated that particular types of medicines suffered more from shortages than others were considered. The number of hours per week spent on the management of drug shortages was estimated by the median number of hours obtained over all answers. Drug shortages affect every stakeholder of the health care system and collaborative efforts are required to manage and mitigate shortages [3]. Drug manufacturers propose alert system to mitigate medicine shortages. Drug shortages are a complex and global phenomenon. 23 MAR 2016 ‘Urgent action’ needed on pharmacist shortages. Regardless of the cause, when a product cannot be delivered at the moment of patient demand, every stakeholder of the health care supply chain is affected. When at least ten respondents of the same country fulfilled the requirements for inclusion as described above, the country was additionally included in the analysis as such. Although respondents indicated information was provided by pharmaceutical companies and wholesalers, information was not provided in advance. Furthermore, physicians and nurses need to be informed to consider future treatment options [3]. B. When the respondent provided no answer on the question, this was indicated as “-“. 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 . This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials. Stark COVID-19 Drug Shortages Warning From Senior EU Regulator The deputy head of the European Medicines Agency has outlined the steps the agency is taking to assess and address the possibility of drug shortages in Europe caused by the coronavirus outbreak, as the number of cases worldwide tops the 98,000 mark. Even more tragically, most 2011 shortages remain unresolved.” The article explained some of the causes of these shortages. It says it has also donated treatments for research and to treat hundreds of thousands of patients around the world. These findings are in accordance with a typology of US drug shortages presented by an IMS report [26]. The susceptibility to drug shortages of generic injectables is sometimes linked to a lack of market attractiveness for generics [27,28]. A survey about drug shortages in European hospital pharmacies was developed based on a review of the literature [1,3,6,7,17–20] and five interviews with Belgian pharmacists. 6). Respondents from the UK, the Netherlands and Eastern Europe indicated tendering as a cause of drug shortages. n recent years, the prevalence of medicine shortages has increased in Europe. The survey was closed on 15 September 2013. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Tendering puts a high pressure on drug prices, especially when the number of competitors that participate in the tender is large. By Anthony Deutsch, Alicja Ptak, Francesco Guarascio. 4). parallel trade) in the cause of drug shortages was suggested. Identifying therapeutic alternatives, purchasing therapeutic alternatives, deliberating with physicians and changing stock each required 2.0 hours/week. Network set up to study drug shortages across Europe. 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). For Figs. When a drug cannot be delivered at the moment of patient demand, every stakeholder in the health care system is affected. In an example cited by FIP, shortages … Answers to the question “Are anti-infective drugs affected by drug shortages?”. Although all disease domains are affected by shortages, many of the drugs involved in US drug shortages are considered to be high alert medications such as heparin and propofol [3,6,11]. Anti-infective drugs and cancer drugs were indicated by the majority of respondents as being affected by drugs shortages in Europe (Figs. Also other reports about drug shortages in US confirm shortages for anti-infectives such as antibiotics [3,6]. The hurdles in the management of drug shortages need to be identified and conquered to allow optimal patient care. Combatting EU drug shortages New guidelines to be issued after EMA report Later this year, the European Medicines Agency (EMA) will issue new guidance, following a report on shortages (the EMA Report), to provide more transparency and to assist national agencies in dealing with this shortage of medicines. Parallel trade was however poorly recognized by respondents in our study which can be explained by the fact that parallel trade affects the hospital drugs to a lesser extent than drugs distributed via community pharmacies. Answers to the question “Are cancer drugs affected by drug shortages?”. The answer “always” and “often” as well as “never” and “rarely” were grouped for the sake of clarity. PLOS ONE promises fair, rigorous peer review, Spain, which has Europe’s highest infection rate, experienced shortages in late August, its medicine agency said. Information was often, always or sometimes obtained from a pharmaceutical company (26% indicated “always-often”, 25% indicated “sometimes”, 12% indicated “rarely-never” and 37% provided no answer, n = 161) and wholesalers (21% indicated “always-often”, 27% indicated “sometimes”, 16% indicated “rarely-never” and 37% provided no answer, n = 161), respondents indicated that also in this case, information was obtained at the time of no delivery for both pharmaceutical companies (42% indicated “at the time of no delivery”, 19% indicated “in advance”, 3% indicated “never” and 37% provided no answer, n = 161) as well as for wholesalers (50% indicated “at the time of no delivery”, 10% indicated “in advance”, 4% indicated “never” and 37% provided no answer, n = 161). Box 1: Medicines shortages: a widespread and persistent problem • In the U.S., new drug shortages rose from 70 in 2006 to a high of 267 in 2011. Drug shortages are a complex and global phenomenon. But despite disappointing WHO trial … According to the results of the survey, drug shortages in these tender markets were not limited to injectable drugs but also show up for the ‘less susceptible’ oral drugs such as drugs for cardiovascular diseases and the central nervous system. See here for a complete list of exchanges and delays. 23 MAY 2019 Pharmacists often succeed in obtaining an equivalent for the drug in shortage but this required a considerable amount of time. Such insufficiencies are not new in the global pharmaceutical market, which is … Clinical and financial impact, causes for drug shortages and measures to handle drug shortages and possible solutions were analyzed for overall respondents. The relative number of respondents was shown for Europe (n = 69), Northern Europe (n = 24), Eastern Europe (n = 10), Southern Europe (n = 13), Western Europe (n = 21), the UK (n = 17), the Netherlands (n = 9). This can be due to the length of the questionnaire as well as to the retrospective nature of particular questions which makes it difficult to answer. The development of policies required 1.6 hours/week while only one hour per week was spent on education of nursing staff. capacity problem) [12,16,29,30]. The antiviral drug has been shown to shorten hospital recovery time in severe cases of COVID-19. In addition, the pharmacy personnel is not always aware of clinical incidents and can underestimate the impact of drug shortages. Other studies relate a high level of frustration to the lack of notification in advance of drug shortages [8]. “Remdesivir has run out,” Dutch Health Ministry spokesman Martijn Janssen told Reuters, adding however that new deliveries were expected shortly. Substitution with alternative drugs can imply medication errors, adverse effects and disease progression. Drugs for cardiovascular diseases were affected by shortages according to a large share of respondents from Northern Europe (33% indicated “yes”, 27% indicated “no” and 40% provided no answer, n = 55), UK (34% indicated “yes”, 25% indicated “no” and 41% provided no answer, n = 44) and the Netherlands (50% indicated “yes”, 44% indicated “no” and 6% provided no answer, n = 16). Pharmacists are often the first health care professionals who will be faced with the shortage. INTRODUCTION. 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). Thirdly, the response rate for particular questions was relatively low. Besides lack of advanced notification of the drug shortage, health care workers mentioned that the information they received about shortages was often inadequate [12]. B-D, only respondents who indicated the disease domain were affected by shortages were considered. Yes Adverse drug reaction profiles vary between Europe and United States. C. Answers to the question “Are these affected drugs mostly cheap or expensive?”. 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. 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 company has set a $2,340 price per patient for wealthier nations. NHS faces drug shortages as Brexit stockpile used in Covid crisis. Yes First, the number of suppliers of generic drugs has dwindled. The authors wish to thank Hospital Pharmacy Europe for their support during development, implementation and follow-up of the online survey. 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]. The EU executive is discussing with Gilead a new supply deal, meant to be sealed by late September or the beginning of October “to prevent a delivery gap,” a Commission official told health experts from EU governments at a meeting in mid-September, minutes show. No, Is the Subject Area "Shortages" applicable to this article? For classes such as immunological products, it is likely that real manufacturing issues or quality problems are involved in shortages [2,20]. Discover a faster, simpler path to publishing in a high-quality journal. Its mission is to collect, analyse and share information about ongoing drug shortages in Europe. C. Answers to the question “Are these affected drugs mostly cheap or expensive?”. Shortages in Europe mostly involved cheap generic and injectable drugs. In our study, drug shortages for anesthetics were only limitedly reported and the survey did not specifically question drug shortages in emergency care. Only descriptive statistics were performed. Shortages are likely to stir debate about the availability and pricing of COVID-19 drugs. For more information about PLOS Subject Areas, click Drug shortage problem needs to be tackled internationally. Furthermore, tendering can limit the number of suppliers, making drugs more susceptible to shortages when other suppliers need to start from zero to address a shortcoming in supply (e.g. 4, a majority of respondents indicated that patients were rarely or never referred to another hospital due to drug shortages. Personnel stress suggests a high level of frustration and sense of responsibility by hospital pharmacists. “NR3 means that an answer on that particular question is not required/not relevant due to a negative answer on a former question. begins with European Union–then alphabetical by country [Europe] Bhavia Mandalia, COVID-19 a global drug shortage, Pledge Times, 14 November 2020. The European market is a single market, which enables the free trade of goods, including pharmaceuticals, across the 28 Member States. 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. None of the authors is employed by TEVA. To understand how to prevent stock shortages in European healthcare supply chains, we … AMSTERDAM/WARSAW/BRUSSELS (Reuters) - European countries are facing shortages of COVID-19 drug remdesivir because limited supplies are running out, officials said, with cases surging and the United States having bought up most of drugmaker Gilead’s output. 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. Studies about the effect of drug shortages in European hospitals are limited. 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]. Medicine shortages affect patient outcomes, pharmacists’ time and budgets, and clinicians, as well as manufacturers, in many ways. The survey enquired about the characteristics of the hospitals where respondents work, whether particular drug classes are more affected by shortages than others, which disease domains are affected by drug shortages and how shortages in particular disease domains can be characterized. Their shortage does not only impact patient safety but also hospital performance in cases where treatment or surgery needs to be postponed, cancelled or even transferred to other hospitals where the necessary treatments are still available [6,8]. 26 APR 2016. Drug Shortages in Europe is a non-profit project created for hospital pharmacists and other healthcare workers. The study is included in a project supported by Research Foundation Flanders (http://www.fwo.be/en/). B-D, respondents who indicated the disease domain is affected were considered. Spain, which has Europe's highest infection rate, experienced shortages in late August, its medicine agency said. A role for European and national policy measures related to the market access (e.g. 6). The answer “always” and “often” as well as “never” and “rarely” are grouped for the sake of clarity. Another study conducted in US confirmed that pharmacists spent in total 9 hours per week to the management of drug shortages [3]. The new directive was expected to enter into force end of March 2014. Mandatory early notification of drug shortages, imposed by the government can help to anticipate the clinical impact of shortages while centralization of information is likely to reduce the workload for hospital pharmacists. According to the respondents, shortages occurred weekly and sometimes daily and the problem has emerged over the past years. In 2012, the European Association of Hospital Pharmacists (EAHP) launched a questionnaire concerning drug shortages in European hospitals [17]. Alternatives potentially have lower efficacy or suboptimal safety profiles and deliberation about alternative agents with physicians, nurses and other health care workers is required [10]. Drug shortages are related to clinical risks such as medication errors in this study as well as in other reports [7,8]. According to Fig. Perception of actions and measures already taken to manage shortages can reveal opportunities for further restriction of drug shortage impact on patients, healthcare workers and the hospital. 6). No, Is the Subject Area "Surveys" applicable to this article? The opinions with regard to rationing of the drug and delay of therapy were more diverse (Fig. 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. The supplies secured so far by the EU were supposed to cover needs until the end of September. Yes Further, early notification will allow well-timed education of health care workers about the use of alternative drugs. A large share of respondents indicated that information was rarely or never received from a professional association (28% indicated “rarely-never”, 19% indicated “sometimes”, 16% indicated “often or always” and 37% provided no answer, n = 161), another hospital (28% indicated “rarely-never”, 22% indicated “sometimes”, 14% indicated “always or often” and 37% provided no answer, n = 161) or from the government (40% indicated “rarely-never”, 16% indicated “sometimes”, 7% indicated “always-often” and 37% provided no answer, n = 161). Healthcare stakeholders have been trying to address stockouts for several decades. Last year, a record of 267 drug shortages were reported, up from 58 in 2004. B. Drug shortages are likely to affect workload and clinical decision-making and a clinical and financial impact needs to be anticipated [4,5]. European country) and completion of the first five questions of the survey. The relative number of respondents per answer was shown for Europe (n = 128), Northern Europe (n = 8), Eastern Europe (n = 20), Southern Europe (n = 30), Western Europe (n = 16), the UK (n = 29), Belgium (n = 9) and the Netherlands (n = 15). Hospital pharmacists presented manufacturing problems as the most important cause of drug shortages. The drug shortages were specified as generic, cheap drugs for injectable administration (Figs. They will start seeking solutions for the problem and initiate negotiations with manufacturers and wholesalers. https://doi.org/10.1371/journal.pone.0119322, Academic Editor: John Conly, University of Calgary, CANADA, Received: April 25, 2014; Accepted: January 28, 2015; Published: March 16, 2015, Copyright: © 2015 Pauwels et al. The total time spent on the management of shortages by hospital pharmacists was estimated to be 12.8 hours/week. EAHP has been active on the issue of medicines shortages for over ten years and has conducted several Medicines Shortages Surveys throughout the years. In order to obtain an equivalent product parallel import was always or often used by 16% to obtain an equivalent product and by 20% of respondents to obtain an alternative product, while a similar number of respondents indicated they use parallel import sometimes, rarely or never and 37% of the respondents provided no answer (n = 161). 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]. Here an important number of respondents indicated that drugs for management of long-term or chronic health issues suffered from shortages (Fig. PLoS ONE 10(3): 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). The European Directive 2004/18 from 31 March 2004 requires hospitals to purchase all supplies and services through public procurement [31]. In European countries and regions, the typology of drug shortages is indeed heterogeneous. KU Leuven Department of Pharmaceutical and Pharmacological Sciences, 3000, Leuven, Belgium. The authors have declared that no other competing interests exist. 1). Poland’s health minister Adam Niedzielski said on Tuesday the drug was in short supply in some hospitals. This was also reflected in the regions and countries, except for Northern Europe and the UK (Fig. The European Medicines Agency (EMA) has posted online a public list of all medicine shortages assessed by the agency as part of plans to help the region deal with drug supply issues. When asking respondents when they received information about a drug shortage from a professional association, most respondents indicated that they only obtained information at the moment they were willing to deliver the drug and they were not able to fulfill this task due to unavailability of the drug (28% indicated “at the time of no delivery”, 20% indicated “in advance”, 16% indicated “never” and 37% provided no answer, n = 161). Twenty nine percent of European respondents were working in a hospital in Western Europe, 34% in Northern Europe, 21% in Southern Europe and 16% in Eastern Europe (n = 161). Fifty seven percent of respondents strongly agreed that an obligation to the producer to notify further shortages could help to solve the problem (n = 161). Germany’s health ministry said remdesivir stocks were sufficient for the coming months. Each country applies its own regulations for the supply and market access of pharmaceuticals, all having possible influences on the availability of drugs [29]. Of these, 161 respondents were retained for further analysis based on relevance of their country of origin for this study (e.g. https://doi.org/10.1371/journal.pone.0119322.g003. 2–3). The potential role of price and reimbursement policies on market attractiveness and availability of drugs in US is discussed in the literature [27,28]. 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. The relative number of respondents was shown for Europe (n = 83), Northern Europe (n = 18), Eastern Europe (n = 17), Southern Europe (n = 20), Western Europe (n = 27), Belgium (n = 4), the Netherlands (n = 13). This study suffers from several limitations. Performed the experiments: KP SS MC IH. Several officials said new deliveries were expected shortly. Currently, insights into the causes of drug shortages are lacking and all players of the drug supply chain tent to blame each other and evade responsibility instead of taking action. By Thomas Sullivan Last updated May 6, 2018. This study investigated the characteristics, impact, causes and management of drug shortages in European hospital pharmacies. SHORTAGES IN EUROPE Medicine shortages may negatively impact patient care and the patient experience. 4). The study is included in a project supported by TEVA. A spokesman for the European Commission, which negotiates medical supply deals on behalf of EU states during the pandemic, was not immediately available for a comment about shortages. Main findings of the survey: https://doi.org/10.1371/journal.pone.0119322.g006. The United States signed a deal for more than 500,000 courses of treatment, accounting for most of Gilead’s output through September. Answers to the question “If yes, are these affected drugs mostly generic or originator drugs?”. 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). 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]. The European market is shaped by regulations and policies at European and national level. An inquiry into the characteristics of drug shortages showed that the typology of drug shortages differs between European regions and countries. Tendering was estimated to play a role in drug shortages by the majority of respondents from Northern Europe (36% indicated “yes, 31% indicated “no” and 33% provided no answer, n = 55), Eastern Europe (27% indicated “yes”, 19% indicated “no” and 54% provided no answer, n = 26), the UK (36% indicated “yes”, 30% indicated “no” and 34% provided no answer, n = 44) and the Netherlands (50% indicated “yes”, 44% indicated “no” and 6% provided no answer, n = 16). Relative numbers were presented as percentages and the considered sample size (n) was included in the result. Cost for patients was indicated by a large share of respondents as being rarely or never affected by drug shortages (Fig. Because of the nature of the survey, it was not required to seek approval from a research ethics committee. According to US studies, the purchase of alternative drugs causes additional costs for the hospital due to reimbursement restrictions [4,7]. Currently, shortages.eu is focused on the European Economic Area. As a result, clinical effects of drug shortages can be reduced. Hospitalisations across Europe have been rapidly increasing, although in most countries still far below levels of the spring. 4). These shortages will affect health care workers as they can experience stress when providing surgery or emergency care, which can influence reporting of these shortages. The World Health Organization (WHO) views drug shortages as a complex global challenge. here. Yes It was not always clear whether respondents considered the total number of working hours spent by their unit, or the number of hours per pharmacist. The drug in short supply can often be substituted by alternative drugs but in some cases such as for chemotherapy or antibiotics, alternatives are of little help [9]. 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