Yes Also other reports about drug shortages in US confirm shortages for anti-infectives such as antibiotics [3,6]. Data Availability: All relevant data are available in Supporting Information file S1 Dataset. Besides lack of advanced notification of the drug shortage, health care workers mentioned that the information they received about shortages was often inadequate [12]. In this way, a financial burden on the hospital can be mitigated. Contributed reagents/materials/analysis tools: KP SS MC IH. https://doi.org/10.1371/journal.pone.0119322.g006. Respondents from the UK, the Netherlands and Eastern Europe indicated tendering as a cause of drug shortages. According to US studies, the purchase of alternative drugs causes additional costs for the hospital due to reimbursement restrictions [4,7]. Next it was investigated in which disease domain drugs were affected by shortages. Relative numbers were presented as percentages and the considered sample size (n) was included in the result. 1). On the question when information about a drug shortage was obtained, 42% of respondents answered that information from the pharmaceutical company was obtained at the time of no delivery, 50% indicated that information from the wholesaler was obtained at the time of no delivery, while 40% of respondents indicated that information was never or rarely received from the government (n = 161). Yes A role for European and national policy measures related to the market access (e.g. Conceived and designed the experiments: KP SS MC IH. Drug shortages are likely to affect workload and clinical decision-making and a clinical and financial impact needs to be anticipated [4,5]. Data were analyzed anonymously. Patients will however not escape from a clinical impact. Funding: KP is funded by the Agency for Innovation by Science and Technology (http://www.iwt.be/english/welcome). Network set up to study drug shortages across Europe. Clinical and financial impact, causes for drug shortages and measures to handle drug shortages and possible solutions were analyzed for overall respondents. In addition, the pharmacy personnel is not always aware of clinical incidents and can underestimate the impact of drug shortages. 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]. The majority of the European respondents reported working in an acute hospital (56%), while 37% were working in a university hospital and 7% were based in a psychiatric hospital (n = 161). Further, most respondents indicated drug shortages rarely or never led to a switch to a lower dose (Fig. Answers to the question “If yes, are these affected drugs mostly generic or originator drugs?”. The causes of shortages are multifactorial and fall within three main categories, namely economic, manufacturing and regulatory causes. No, Is the Subject Area "Finance" applicable to this article? They will start seeking solutions for the problem and initiate negotiations with manufacturers and wholesalers. It has now enough doses to meet needs for the coming weeks, the health ministry said on Tuesday. 4). 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). The United States signed a deal for more than 500,000 courses of treatment, accounting for most of Gilead’s output through September. The causes of shortages are understood to be multifactorial, including problems in production, global consolidation of manufacturing, unintended impacts of pricing and tendering policies, as well as problems within the supply chain. Improving education of nursing staff might be one of the targets to limit the occurrence of medication errors. 1). 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). 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. 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. Its latest shipment from the EU order arrived just last Friday. 5). 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. 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). In Europe, the largest share of respondents indicated life preserving and life sustaining drugs were most affected by drug shortages (Fig. 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. Medicine shortages affect patient outcomes, pharmacists’ time and budgets, and clinicians, as well as manufacturers, in many ways. The supplies secured so far by the EU were supposed to cover needs until the end of September. To understand how to prevent stock shortages in European healthcare supply chains, we … Drug shortage problem needs to be tackled internationally. On the question of whether patient care is affected by shortages, opinions are diverse with 50% of respondents saying it is affected while another 46% of respondents indicated that the hospital is able to manage the problem without the patient being affected [19]. Data about the characteristics of the drugs in shortage and the causes of the shortage were collected from publicly available online reporting systems. Other studies relate a high level of frustration to the lack of notification in advance of drug shortages [8]. 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 . “NR3 means that an answer on that particular question is not required/not relevant due to a negative answer on a former question. Conclusions Reporting of drug shortages in Europe needs to be standardized and more transparency about the reasons for drug shortage is required to investigate the problem. This study suffers from several limitations. The survey was closed on 15 September 2013. Anti-infective drugs and cancer drugs were indicated by the majority of respondents as being affected by drugs shortages in Europe (Figs. Further, drug shortages in Europe were associated with a clinical and financial burden and additional workload for the hospital pharmacy. 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). When the respondent provided no answer on the question, this was indicated as “-“. 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. Characteristics of drug shortages were compared between different geographical regions i.e. C. Answers to the question “Are these affected drugs mostly cheap or expensive?”. The authors are thankful to Thomas Bodvin for his contribution to the development of the survey. Healthcare stakeholders have been trying to address stockouts for several decades. a tender-like system) and add a guarantee for sustainable supply to the conditions to win a tender [32]. 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]. Nevertheless, it cannot be neglected that drug shortages are also affecting European hospitals and that this puts the patients at risk. 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. 14 NOV 2019 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. https://doi.org/10.1371/journal.pone.0119322.g002. Two hundred and eighty respondents participated in the survey. 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. 2016 ‘ Urgent action ’ needed on pharmacist shortages and materials was shown n... Conceived and designed the experiments: KP SS mc IH are looking to Brussels for an answer vary Europe! 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