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). According to US studies, the purchase of alternative drugs causes additional costs for the hospital due to reimbursement restrictions [4,7]. Pharmacists often succeed in obtaining an equivalent for the drug in shortage but this required a considerable amount of time. No, Is the Subject Area "Pharmacists" applicable to this article? 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]. 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 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]. The questionnaire results revealed that 99% of hospital pharmacists experienced shortages in the past year [19]. Eastern Europe is even more characterized by the lowest prices among Europe, making countries in this jurisdiction an attractive market for export. Yes The government was limitedly involved in the management of a shortage. here. 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. 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. More than 30% of respondents indicated that drug shortages in Europe were always or often associated with increased costs for hospitals, increased personnel costs and more expensive alternative drugs (n = 161). Answers to the question “If yes, are these affected drugs mostly generic or originator drugs?”. 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. https://doi.org/10.1371/journal.pone.0119322.g004, https://doi.org/10.1371/journal.pone.0119322.g005. All quotes delayed a minimum of 15 minutes. Poland’s health minister Adam Niedzielski said on Tuesday the drug was in short supply in some hospitals. The survey was launched in the May-June issue of HPE which was distributed on the first of June 2013 to 12,000 subscribers. This study suffers from several limitations. 6). This was also reflected in the regions and countries, except for Northern Europe and the UK (Fig. 4, a majority of respondents indicated that patients were rarely or never referred to another hospital due to drug shortages. 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. In the EU, most medicine shortages are dealt with at national level by national competent authorities. A mandatory early notification of drug shortages imposed by the government will allow health care workers to anticipate a drug shortage in an early stage. 28 JAN 2015. Gilead has expanded its production capacity. As a result, clinical effects of drug shortages can be reduced. 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/. According to Fig. at the time of no delivery) [8]. 26 APR 2016. Drug shortages are a growing source of concern and industry is taking every possible step in our capacity to minimise the impact of shortages for patients. 1 Numerous signs point to the growing importance of this issue, particularly in Europe and North America. A. Such insufficiencies are not new in the global pharmaceutical market, which is … No, Is the Subject Area "Finance" applicable to this article? Of the 161 respondents, 35% of respondents provided no answer on this question. First, the number of suppliers of generic drugs has dwindled. Five percent indicated that the manufacturer never made an effort and four percent indicated that an effort to solve the shortage was always made by the manufacturer. Spain, which has Europe’s highest infection rate, experienced shortages in late August, its medicine agency said. 1). Both have been given to U.S. President Donald Trump, who is also receiving an experimental antibody cocktail. 5). NHS faces drug shortages as Brexit stockpile used in Covid crisis. According to the respondents, shortages occurred weekly and sometimes daily and the problem has emerged over the past years. 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]. Two hundred and eighty respondents participated in the survey. Welcome to Drug Shortages Canada, the website for reporting drug shortages and discontinuations in Canada. a tender-like system) and add a guarantee for sustainable supply to the conditions to win a tender [32]. “Due to the increased hospital admissions, the demand for remdesivir is increasing rapidly,” the Dutch spokesman said. 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. Adverse drug reaction profiles vary between Europe and United States. The drug shortages were specified as generic, cheap drugs for injectable administration (Figs. 23 MAR 2016 ‘Urgent action’ needed on pharmacist shortages. Besides lack of advanced notification of the drug shortage, health care workers mentioned that the information they received about shortages was often inadequate [12]. For immunological products and vaccines, shortages were indicated by a major share of respondents from Southern Europe (35% indicated “yes”, 29% indicated “no” and 35% provided no answer, n = 34), Western Europe (33% indicated “yes”, 26% indicated “no” and 41% provided no answer, n = 46) and the Netherlands (44% indicated “yes”, 31% indicated “no” and 25% provided no answer, n = 16). 1). Drug shortages are recognised as a global issue by the World Health Organisation (WHO) with research indicating that the problem has been increasingly affecting European countries. parallel trade) in the cause of drug shortages was suggested. D. Answers to the question “What is the most affected form?”. EMA shortages catalogue National registers European Medicines Agency (EMA) publishes … While Europe is one of the world’s top manufacturers of drugs, the raw ingredients often come from China or India. PLOS ONE promises fair, rigorous peer review, Hospital pharmacists presented manufacturing problems as the most important cause of drug shortages. PLoS ONE 10(3): Currently, shortages.eu is focused on the European Economic Area. 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. 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). 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). 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. The answers of respondents employed in European countries who completed the first four questions of the survey (country of origin, type of hospital (acute/university/psychiatric), size of hospital and the question “do you have the impression that particular drug types suffer more from shortages than others?”) were considered for further analysis. The Covid-19 shock led to shortages in essential drugs in many European countries, including France. Yes Substitution with alternative drugs can imply medication errors, adverse effects and disease progression. In 2012, the European Association of Hospital Pharmacists (EAHP) launched a questionnaire concerning drug shortages in European hospitals [17]. 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. Yes This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials. EAHP has been active on the issue of medicines shortages for over ten years and has conducted several Medicines Shortages Surveys throughout the years. Near miss errors were not included in this questionnaire and also patient outcomes were not surveyed. INTRODUCTION. For classes such as immunological products, it is likely that real manufacturing issues or quality problems are involved in shortages [2,20]. Contributed reagents/materials/analysis tools: KP SS MC IH. B-D, only respondents who indicated the disease domain were affected by shortages were considered. 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. https://doi.org/10.1371/journal.pone.0119322.g006. In Poland, prices are on average 30% lower than in Germany [35]. The World Health Organization (WHO) views drug shortages as a complex global challenge. Hospitalisations across Europe have been rapidly increasing, although in most countries still far below levels of the spring. 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). In this way, a financial burden on the hospital can be mitigated. Drug Shortages International. 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]. Conceived and designed the experiments: KP SS MC IH. https://doi.org/10.1371/journal.pone.0119322.s001. The online survey was setup in SurveyMonkey (2013) and tested by three authors of the manuscript, one student involved in the project, three affiliates of the project sponsor and the members of the editorial board of Hospital Pharmacy Europe (HPE) to collect comments about the length of the survey and clarity of the questions. 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). Next it was investigated in which disease domain drugs were affected by shortages. For example, immunological products involve a large amount of biologically active ingredients which are unique and cannot be included in tendering. Yes B. The supplies secured so far by the EU were supposed to cover needs until the end of September. The answer “always” and “often” as well as “never” and “rarely” are grouped for the sake of clarity. C. Answers to the question “Are these affected drugs mostly cheap or expensive?”. 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. Data Availability: All relevant data are available in Supporting Information file S1 Dataset. It says it has also donated treatments for research and to treat hundreds of thousands of patients around the world. The purchase of overall equivalent or alternative therapeutic substitutes is estimated to cost US hospitals about 215$ million annually [10]. Further, early notification will allow well-timed education of health care workers about the use of alternative drugs. The United States signed a deal for more than 500,000 courses of treatment, accounting for most of Gilead’s output through September. 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. Two pharmacists to lead deprescribing network across England. By Thomas Sullivan Last updated May 6, 2018. In addition, the pharmacy personnel is not always aware of clinical incidents and can underestimate the impact of drug shortages. While pharmaceutical companies and wholesalers are already involved in providing information and solutions, a role is still left for the government. 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. While dexamethasone, a generic medicine, is widely available and cheap, remdesivir is protected by Gilead’s patent. Cost for patients was indicated by a large share of respondents as being rarely or never affected by drug shortages (Fig. Drug shortage problem needs to be tackled internationally. Remdesivir and the steroid dexamethasone are the only drugs authorised in Europe to treat COVID-19. To understand how to prevent stock shortages in European healthcare supply chains, we … 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. 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]. These findings are in accordance with a typology of US drug shortages presented by an IMS report [26]. An online survey was designed based on a review of the literature and interviews and was sent to subscribers of Hospital Pharmacy Europe between June and September 2013. No, Is the Subject Area "Drug delivery" applicable to this article? Medicine shortages can occur for many reasons, such as manufacturing difficulties or problems affecting the quality of medicines that can impact on patient care. A role for European and national policy measures related to the market access (e.g. Labor costs associated with managing drug shortages are estimated at $216 million annually in the U.S. [12]. 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]. Drug Shortages in Europe is a non-profit project created for hospital pharmacists and other healthcare workers. D. Answers to the question “What is the most affected form?”. From then on, a link to the survey was announced in the weekly online bulletin of HPE, sent to 7,000 subscribers. US FDA launches app that alerts public about drug shortages. When a drug cannot be delivered at the moment of patient demand, every stakeholder in the health care system is affected. These results showed that pharmaceutical companies and wholesalers are already involved in the management of drug shortages, while a role is still reserved for the government. 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]. For more information about PLOS Subject Areas, click Although respondents indicated information was provided by pharmaceutical companies and wholesalers, information was not provided in advance. Nevertheless, it cannot be neglected that drug shortages are also affecting European hospitals and that this puts the patients at risk. Drug shortages affect every stakeholder of the health care system and collaborative efforts are required to manage and mitigate shortages [3]. 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