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The study focuses on drug safety regulation capture, reveals the inner mechanism and evolutionary characteristics of drug safety regulation capture and provides suggestions for effective regulation by pharmacovigilance.

The article introduces prospect theory into the game strategy analysis of drug safety events, constructs a benefit perception matrix based on psychological perception and analyzes the risk selection strategies and constraints on stable outcomes for both drug companies and drug regulatory authorities. Moreover, simulation was used to analyze the choice of results of different parameters on the game strategy.

The results found that the system does not have a stable equilibrium strategy under the role of cognitive psychology. The risk transfer coefficient, penalty cost, risk loss, regulatory benefit, regulatory success probability and risk discount coefficient directly acted in the direction of system evolution toward the system stable strategy. There is a critical effect on the behavioral strategies of drug manufacturers and drug supervisors, which exceeds a certain intensity before the behavioral strategies in repeated games tend to stabilize.

In this article, the authors constructed the perceived benefit matrix through the prospect value function to analyze the behavioral evolution game strategies of drug companies and FDA in the regulatory process, and to evaluate the evolution law of each factor.

Newly marketed drugs present unavoidable risks, no matter how diligent the level of pre-market review. Numerous adverse drug events attest to the need for post-market vigilance. However, the Food and Drug Administration monitors drugs with considerably less rigor after launch than before. This burdens both public health and public trust in the safety of new medicines. As new technologies such as genomics guide a larger share of drug development, the issue will become more acute. Most reform proposals present considerable logistical challenges. A promising alternative is to harness existing managed care databases to search for drug effects.

To strengthen the correlation analysis on risk factors of drug production safety and reduce the influence due to fuzzy judgments, a safety risk assessment method based on Grey-Analytic Network Process (G-ANP) is proposed.

First, an index system evaluating drug production safety risk is constructed according to the “Good Manufacture Practice of Medical Products,” next the influence weight of each risk index is derived by using the Analytic Network Process, then the grey number of each risk index is determined by further utilizing the grey statistical theory, and finally the risk level of drug production is obtained.

An empirical study is conducted and the results support the feasibility and practicability to use G-ANP method for drug production safety risk evaluation. The results of the case show that it is feasible and practical to use G-ANP method for drug production safety risk evaluation.

The innovation lies in the use of G-ANP method to fully consider the interdependence and interaction between the risk factors of drug production safety, which improves the objectivity in judging the risk level of drug production and provides a scientific basis for pharmaceutical manufacturers to formulate further decisions and management in the case of insufficient quantification of risk factors. Based on the findings, more targeted suggestions are made to reduce the production risk of pharmaceutical enterprises.

The purpose of this paper is to contribute to the literature by assessing factors that typically engender adverse drug reactions (ADRs) jeopardizing medical safety. These factors are population knowledge, clarity in disclosure of the risks inhering ADRs and ADRs incidence. It seeks to minimize negative effect by early identification of drug reactions.

On the one hand, the study employs a model that shows relationships between various factors, and on the other hand, ADRs medical safety in the public healthcare sector.

Clarity of consultancy services in public healthcare significantly impact ADR medical safety. Population and healthcare provider education on ADRs medical safety are necessities. Implementation of an ADR reporting system in every healthcare institute is essential. This helps service providers to give a clear and accurate information to patients. It also makes patients more aware of consequences of ADRs.

Time, place and sampling method are found to be the main study limitations. Researchers should take into their consideration the significant relationships between the factors and ADRs medical safety to improve level of awareness in the healthcare public sector.

Ways to improve ADR medical safety in healthcare sector are underscored. Healthcare service providers and professionals need to take into account the stipulated study factors in order to improve medical safety and reduce unnecessary medical costs.

Very few studies have been conducted on this topic; most of those that have been conducted were undertaken in western countries. This study assesses the level of healthcare safety in the country and suggests mechanisms to elevate that level.

The purpose of this study is to analyze newspaper coverage of ethical issues in the pharmaceutical industry.

The top five US newspapers were audited over two years and yielded 376 articles, which appeared as front‐page stories or editorials. First, headlines were analyzed and categorized as positive, negative, or neutral toward the industry. Next, the full‐text of each article was analyzed and ethical issues in each article were categorized. Then, articles were evaluated to determine whether the opposing point of view was included. Finally, comparisons were made between the identified issues and the issues cited by PhRMA, the pharmaceutical industry's trade association.

Analysis of the ethical issues revealed different results for the two years. In 2004, the most common issues covered were drug pricing, data disclosure and importation/reimportation. In 2005, drug safety was the number one issue, due to Vioxx^® with drug pricing a distant second. Headlines were negative 57.1 percent in 2004 and 43.9 percent in 2005. Full‐text articles were negative 69.5 percent in 2004 and 60.1 percent in 2005. The opposing point of view was included 77.7 percent in 2004 and increased to 82.7 percent in 2005. Ethical issues cited by PhRMA, (e.g. drug pricing), received heavy coverage but several identified issues were not on PhRMA's list, notably drug safety.

Pharmaceutical companies need to take action to address the negative impression about them.

This research establishes a practical methodology to evaluate newspaper coverage of ethical issues involving the pharmaceutical industry.

A key feature of human rights in health is access to safe, effective and affordable medicines. Pharmacovigilance is advocated for monitoring intended/unintended effects of medicines to assure their safety. The purpose of this paper is to synthesize knowledge about supply chain impediments to safe medicines in developing nations and contribute to future development of research in this field.

This paper conducts a structured literature review based on Preferred Reporting Items for the Systematic Reviews and Meta-Analyses guidelines. It aims at profiling supply chain impediments to safe medicines in developing nations by reviewing 46 recent pharmacovigilance-specific papers published between 2005 and 2020.

Analysis of reviewed articles identified criticality of supply chain impediments that affect constituents across pharmaceutical in developing nations, which still struggle to maintain robust national pharmacovigilance systems due to lack of awareness, policy and practices.

Research results can be applied by pharmaceutical industry decision-makers and drug safety professionals in developing nations. Because the review is qualitative in nature, its implication ought to be tested after actual implementation.

This review can help identify underinvestigated impediments and methods to aid in developing new pharmacovigilance knowledge areas in developing nation context.

The review uncovers gaps in global health equity dialogue in developing nations. It also recognizes that macrolevel supply chain impediments exist due to unfair disease burden and health inequities in developing nations.

The paper examines supply chain impediments to safe medicines in developing nations with insights for future pharmacovigilance research. Identifying and classifying supply chain impediments through this review is the first step toward creating effective interventions for these impediments to safe medicines.

According to literature, interruptions during drug administration lead to a significant proportion of medication errors. Evidence on the effectiveness of interventions to reduce interruption is still limited. The purpose of this paper is to explore main reasons for interruptions during drug administration rounds in a geriatric ward of an Italian secondary hospital and test the effectiveness of a combined intervention.

This is a pre and post-intervention observational study based on direct observation. All nurse staff (24) participated to the study that lead to observe a total of 44 drug dispensing rounds with 945 drugs administered to 491 patients in T0 and 994 drugs to 506 patients in T1.

A significant reduction of raw number of interruptions (mean per round from 17.31 in T0 to 9.09 in T1, p<0.01), interruptions/patient rate (from 0.78 in T0 to 0.40 in T1, p<0.01) and interruptions/drugs rate (from 0.44 in T0 to 0.22 in T1, p<0.01) were observed. Needs for further improvements were elicited (e.g. a greater involvement of support staff).

Nurse staff should be adequately trained on the risks related to interruptions during drug administration since routine activity is at high risk of distractions due to its repetitive and skill-based nature.

A strong involvement of both MB and leadership, together with the frontline staff, helped to raise staff motivation and guide a bottom-up approach, able to identify tailored interventions and serve concurrently as training instrument tool.