Productie en klinische toepassingen van [15O]gelabelde gassen.

Contains fulltext : 71362.pdf (publisher's version ) (Open Access

Blockchain technology applications to postmarket surveillance of medical devices

Introduction: The amount of mandatory data that needs to be analyzed as part of a medical device postmarket surveillance (PMS) system has grown exponentially in recent times. This is a consequence of increasingly demanding and complex regulatory requirements from Health Authorities, aimed at a better understanding of the medical device safety evaluation. Proactive approaches to PMS processes are becoming more necessary as regulators increase the scrutiny of device safety. New technologies have been explored to address some of the challenges associated with this changing regulatory environment. Areas covered: This paper focuses on the different technical aspects of blockchain and how this new technology has the potential to support the ongoing efforts to improve the PMS system for medical devices. Expert opinion: To address these challenges, we suggest to generate a private PMS data permissioned blockchain with a proof-of-authority consensus mechanism, to which only a restricted number of designated and audited participants have authorization to validate transactions and add them to the PMS data blockchain ledger. Blockchain has the potential to support a more efficient approach, which could offer many advantages to the different stakeholders involved in the PMS process, such as supporting with new regulatory initiatives

Trends in prescribing for heart failure in Dutch primary care from 1996 to 2000

PURPOSE: The aim of this study is to explore trends in primary care prescribing for chronic heart failure (CHF) over a 5-year period (1996-2000). METHODS: This study consisted of repeated cross-sectional surveys in a dynamic cohort from the Integrated Primary Care Information (IPCI) primary care database. The cohort comprised all patients aged > or = 55 years with a CHF diagnosis and prescribed a cardiovascular medication during the study period. The point prevalence per calendar year was determined for each of the main drug groups used to treat CHF. RESULTS: The study population consisted of 3121 CHF patients. Small increases were seen in the percentage of CHF patients prescribed spironolactone (4.6%, 95% CI: 2.3-6.9%), beta-blockers (6.1%, 95% CI: 2.6-9.5%) and angiotensin II antagonists (6.8%, 95% CI: 5.1-8.6%) during the study period, while the prescribing of digoxin decreased (-4.4%, 95% CI: -8.2 to -0.7). Prescribing of diuretics (difference: -0.7% 95% CI: -2.7-4.2) and ACE inhibitors (difference: 4.0% 95% CI: -0.1-8.2%) remained unchanged. CONCLUSIONS: Prescription of some drug groups for CHF increased. However, given the new scientific evidence that has emerged in past 15 years regarding CHF pharmacotherapy, the changes observed were less than expected. Record 2 of 6 - SilverPlatter MEDLINE(R)

Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs.

Contains fulltext : 59302.pdf (publisher's version ) (Closed access)CONTEXT: Reduction of gastric acid secretion by acid-suppressive therapy allows pathogen colonization from the upper gastrointestinal tract. The bacteria and viruses in the contaminated stomach have been identified as species from the oral cavity. OBJECTIVE: To examine the association between the use of acid-suppressive drugs and occurrence of community-acquired pneumonia. DESIGN, SETTING, AND PARTICIPANTS: Incident acid-suppressive drug users with at least 1 year of valid database history were identified from the Integrated Primary Care Information database between January 1, 1995, and December 31, 2002. Incidence rates for pneumonia were calculated for unexposed and exposed individuals. To reduce confounding by indication, a case-control analysis was conducted nested in a cohort of incident users of acid-suppressive drugs. Cases were all individuals with incident pneumonia during or after stopping use of acid-suppressive drugs. Up to 10 controls were matched to each case for practice, year of birth, sex, and index date. Conditional logistic regression was used to compare the risk of community-acquired pneumonia between use of proton pump inhibitors (PPIs) and H2-receptor antagonists. MAIN OUTCOME MEASURE: Community-acquired pneumonia defined as certain (proven by radiography or sputum culture) or probable (clinical symptoms consistent with pneumonia). RESULTS: The study population comprised 364,683 individuals who developed 5551 first occurrences of pneumonia during follow-up. The incidence rates of pneumonia in non-acid-suppressive drug users and acid-suppressive drug users were 0.6 and 2.45 per 100 person-years, respectively. The adjusted relative risk for pneumonia among persons currently using PPIs compared with those who stopped using PPIs was 1.89 (95% confidence interval, 1.36-2.62). Current users of H2-receptor antagonists had a 1.63-fold increased risk of pneumonia (95% confidence interval, 1.07-2.48) compared with those who stopped use. For current PPI users, a significant positive dose-response relationship was observed. For H2-receptor antagonist users, the variation in dose was restricted. CONCLUSION: Current use of gastric acid-suppressive therapy was associated with an increased risk of community-acquired pneumonia

Challenges Associated with the Safety Signal Detection Process for Medical Devices

Background: Previous safety issues involving medical devices have stressed the need for better safety signal detection. Various European Union (EU) national competent authorities have started to focus on strengthening the analysis of vigilance data. Consequently, article 90 of the new EU regulation states that the European Commission shall put in place systems and processes to actively monitor medical device safety signals. Methods: A systematic literature review was conducted to synthesize the current state of knowledge and investigate the present tools used for medical device safety signal detection. An electronic literature search was performed in Embase, Medline, Cochrane, Web of science, and Google scholar from inception until January 2017. Articles that included terms related to medical devices and terms associated with safety were selected. A further selection was based on the abstract review. A full review of the remaining articles was conducted to decide on which articles finally to consider relevant for this review. Completeness was assessed based on the content of the articles. Results: Our search resulted in a total of 20,819 articles, of which 24 met the inclusion criteria and were subject to data extraction and completeness scoring. A wide range of data sources, especially spontaneous reporting systems and registries, used for the detection and assessment of product problems and patient harms associated with the use of medical devices, were studied. Coding is remarkably heterogeneous, no agreement on the preferred methods for signal detection exists, and no gold standard for signal detection has been established thus far. Conclusion: Data source harmonization, the development of gold standard signal detection methodologies and the standardization of coding dictionaries are amongst the recommendations to support the implementation of a new proactive approach to signal detection. The new safety surveillance system will be able to use real-world evidence to support regulatory decision-making across all jurisdictions

Targeting outpatient drug safety: recommendations of the Dutch HARM-Wrestling Task Force.

Item does not contain fulltextBACKGROUND: Two Dutch observational studies (HARM [Hospital Admissions Related to Medication] and IPCI [Integrated Primary Care Information]) have shown that approximately 5% of all unplanned hospital admissions are associated with adverse drug events (ADEs), of which 40-46% are potentially preventable. These studies prompted the initiation of a Dutch multidisciplinary task force, which was assigned to reduce the number of prescriber-related hospital admissions related to medications (HARMs) in a quick-win way. OBJECTIVE: The aim of the study was to identify the most relevant ADEs and to develop a limited number of recommendations for concrete interventions, which should be feasible and relatively easy to convert into computerized drug safety alerts. METHOD: To identify the major ADEs, crude data of HARM and IPCI were reanalysed and compared with different international studies, followed by structured literature searches for further characterization of the identified ADEs, their risk factors and potential risk-reduction strategies. Based on this information, the Task Force drew up general and drug-specific recommendations. As the recommendations of the Task Force are a mixture of evidence- and expert-based risk-reducing strategies, they have been graded in accordance with the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. RESULTS: Seven pharmacologically predictable ADEs associated with ten drug classes were responsible for more than half of all potentially preventable hospital admissions in the IPCI and HARM studies, which was comparable to the results of international studies. Gastrointestinal and other bleedings were the most frequent ADE, followed by disturbances of diabetes mellitus control, electrolyte disturbances, fractures, renal insufficiency and heart failure. Nine general and 34 drug-specific recommendations were developed. CONCLUSIONS: As HARMs constitute a significant public health problem, the Task Force underlines the need to implement its recommendations as soon as possible. They do not replace existing guidelines, but reinforce, complement and fine-tune existing Dutch and international guidelines. Further research is still required to assess the cost consequences and cost effectiveness of some recommendations, and to monitor the implementation of the recommendations and their effect on the incidence of potentially preventable HARMs