Overview of the causes and management of drug shortages in the United States and in Hungary

Drug shortages are a multifactorial international concern that is increasingly reported all over the world. A continuously rising number of cases could be observed since 2001, but the issue is particularly significant since 2009. In Hungary, the same increasing tendency was observed; while in 2012 464 shortages occurred, in 2020 1466 cases were reported. According to the Food and Drug Administration, there are three root causes behind the shortages, but several factors can be derived from them. This paper aims at conducting a comprehensive review of literature, exploring these factors in detail and thereby explaining how each of these factors contributes to shortages. Furthermore, it will illustrate how the lack of sufficient information due to an imperfect warning system also contributes to the issue. As the problem affects every stakeholder in the supply chain from patients to Marketing Authorisation Holders, each party should be involved in the development and implementation of mitigating strategies that can provide the basis of policy measures. The article highlights how international trends both in terms of affected therapeutic areas and causes of shortages are reflected in the Hungarian markets; therefore similar approaches could be adapted to tackle the issue domestically and deliver enduring solutions

Qualitative and quantitative research of medication review and drug-related problems in Hungarian community pharmacies: a pilot study

Abstract Background Pharmaceutical care is the pharmacist’s contribution to the care of individuals to optimize medicines use and improve health outcomes. The primary tool of pharmaceutical care is medication review. Defining and classifying Drug-Related Problems (DRPs) is an essential pillar of the medication review. Our objectives were to perform a pilot of medication review in Hungarian community pharmacies, a DRP classification was applied for the first time. Also, our goal was the qualitative and quantitative description of the discovered DRPs, and of the interventions for their solution in order to prove the safety relevance of the service and to map out the competence limits of GPs and community pharmacists to drug therapy. Methods The project took place in Hungarian community pharmacies. The study was performed with patients taking vitamin K antagonist (VKA) and/or ACE inhibitor and NSAID simultaneously (ACEI-NSAID). 61 pharmacists and 606 patients participated in the project. Pharmacists reviewed the medication for 3 months and the classification of DRPs was performed (category of DRP1 – DRP6). Patient data were statistically analyzed. Results Patients consumed on average 7.9 ± 3.1 medications and other products. 571 DRPs were detected in 540 patients, averaging 1.06 DRPs per patient (SD = 1.07). The highest frequency category was DRP5 (non-quantitative safety problem; 51.0%). The most common root cause was an interaction (42.0%) and non-adherence (19.4%.). The most commonly used intervention was education (25.4%) and medication replacement by the pharmacist (20.1%). The changing of the frequency and dosage in any direction were negligible. Conclusions Patients are struggling with many DRPs that can be assessed and categorized by this system and which remain unrecognizable without pharmacists. Further projects need to be developed to assist in the development of physician-pharmacist cooperation and the widespread dissemination of pharmaceutical care

Nafamostat reduces the incidence of post-ERCP pancreatitis : a systematic review and meta-analysis of randomized controlled trials

Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). As the management of pancreatitis is limited, clinical approaches focus on the prevention of post-ERCP pancreatitis (PEP). In theory, the serine protease inhibitor nafamostat can reduce circulating inflammatory mediators in pancreatitis. We aimed to investigate the effect of nafamostat in the prevention of PEP in this systematic review and meta-analysis. The protocol for this review was registered in PROSPERO (CRD42022367988). We systematically searched five databases without any filters on 26th September 2022. The eligible population was adult patients undergoing ERCP. We compared the PEP preventive effect of nafamostat to placebo. The main outcome was the occurrence of PEP. We calculated the pooled odds ratios (OR), mean differences (MD), and corresponding 95% confidence intervals (95%CI) and multilevel model. The risk of bias was assessed using the Rob2 tool. Seven randomized controlled trials involving 2,962 patients were eligible for inclusion. Nafamostat reduced the overall incidence rate of PEP [20 mg OR 0.50; 95%CI 0.30-0.82 and 50 mg 0.48; 95%CI 0.24-0.96]. However, the occurrence of mild PEP was significantly reduced only in the subgroup receiving 20 mg nafamostat [OR 0.49; 95%CI 0.31-0.77]. Overall, nafamostat therapy reduced moderate PEP in high-risk patients [OR 0.18; 95%CI 0.0.4-0.84] and mild PEP in low-risk patients [OR 0.32; 95%CI 0.17-0.61]. Nafamostat is an effective therapy in the prevention of mild post-ERCP pancreatitis. Further research is required to determine the cost-effectiveness of this therapy

No evidence for the benefit of PPIs in the treatment of acute pancreatitis : a systematic review and meta-analysis

Although current guidelines do not recommend the use of proton pump inhibitors (PPIs) in the standard of care of acute pancreatitis (AP), they are often prescribed in clinical practice, mainly for ulcer stress prophylaxis. In this systematic review and meta-analysis we evaluated the association between the use of PPIs in the management of AP and various clinical outcomes. We conducted the systematic research in six databases without restrictions on January 24th, 2022. We investigated adult patient with AP, who were treated with PPI compared to conventional therapy. The pooled odds ratios, mean differences, and corresponding 95% confidence intervals were calculated with random effect model. We included six RCTs and three cohort studies, consisting of 28,834 patients. We found a significant decrease in the rate of pancreatic pseudocyst formation in patients who received PPI treatment. PPI use was associated with a higher risk of GI bleeding, however this finding could be due to the patients' comorbid conditions. We found no significant difference in the rates of 7-day mortality, length of hospital stay, and acute respiratory distress syndrome between the groups. The available data on this topic are limited; therefore, further well designed RCTs are needed to evaluate the potential benefits and adverse effects of PPIs in AP

Az új algoritmusok és kódolási eljárások alkalmazása a mobil hírközlésben és informatikában = Application of new algorithms and coding procedures in mobile communications and computing

A kutatási munka során az alábbi résztémákban értünk el eredményeket: - mobil IP, - all IP hálózatok, - útkeresési algoritmusok, - hívásátadási algoritmusok, - mobil technológiák együttműködése, - a szolgáltatás minősége (QoS), - a mobil és informatikai hálózatok és rendszerek biztonsági kérdései, - több-felhasználós vétel, - kódosztásos többszörös hozzáférés, - forgalmi modellezés, - kódkonstrukció kódosztásos technológiákhoz, - kvantum számítástechnikai eljárások, - gráfelmélet, - kombinatorikus optimalizálás. A fenti szakterületeken végzett kutatásaink eredményei közül azokat emeljük ki, amelyeket az alábbi témákban értünk el: - A heterogén mobil hálózatok együttműködési problémái, - A mobil Internet Protokoll alkalmazásával kapcsolatos vizsgálatok, - Többfelhasználós detekciós módszerek a kódosztásos többszörös hozzáféréses mobil rendszerekben, - A heterogén mobil hálózatok forgalmi modellezése, - A mobil informatikai és távközlési hálózatok, rendszerek és szolgáltatások - biztonsági kérdései, - Kvantum számítástechnika és mérnöki alkalmazásai, - Útkeresési és csatornakijelölési algoritmusok fejlesztése és vizsgálata mobil hálózatok számára, alkalmazott gráfelmélet. A kutatásban résztvevők az eredményeket három megvédett PhD disszertációban, egy benyújtás előtt álló akadémiai doktori értekezésben és több beadás előtt álló PhD értekezésben használták fel. A tudományos iskola publikációs listája 135 elemből áll. | The members of the Scientific School have got new results in the following scientific fields: - Mobile IP, all IP networks, - Routing algorithms, - Hand-over algorithms, - Interworking of heterogeneous mobile technologies, - Quality of services (QoS), - Security problems of mobile and information networks and systems, - Multi-user detection, - Code division multiple access, - Traffic modeling, - Code construction for code division technologies, - Quantum computing, - Graph theory, - Combinatorial optimization. On the above mentioned scientific field we have the most important results in the following areas: - Interoperability issues of heterogeneous mobile networks, - Investigations on the applicability of mobile Internet Protocol, - Multi-user detection methods in code division multiple access systems, - Traffic models of heterogeneous mobile networks, - Security issues of mobile information and telecommunication networks, systems and services, - Quantum computing and its engineering applications, - Development and research of routing and channel assigning algorithms for mobile networks, application of the graph theory. The participants of the research used their results in three defended PhD theses, in a dissertation for DSc title, and in some other PhD theses before the final process. The number of the publications of the Scientific School is 135

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed