Rosa Rodriguez-Monguio

Assessing the Economic Impact of Adverse Drug Effects

AbstractAlthough most commonly used drugs cause adverse effects, some of them with potentially serious consequences, relatively little is known about their economic impact. The purpose of this review is to summarise information describing the cost of treatment of drug-induced adverse effects as an additional cost of pharmaceutical treatment. The focus of this study was limited to the overall economic impact of drug-related morbidity and to the economic analysis of a single class of drugs with different safety profiles.Several studies carried out in the US have investigated adverse drug effects experienced by hospitalised patients and their impact on hospital costs. Patients who developed adverse effects were hospitalised an average of 1.2–3.8 days longer than patients who did not, with additional hospital costs of

Market withdrawal of new molecular entities approved in the United States from 1980 to 2009

US2284–5640 per patient (2000 values). Other research studies in different countries have quantified the incidence and economic consequences of adverse drug effects that occur in the ambulatory setting and that generate hospital admission and emergency department visits. They have shown that preventable adverse effects constitute between 43.3% and 80% of all adverse outcomes leading to emergency visits and hospital admissions, and disproportionately increase healthcare costs. Finally, a recent estimation revealed that in the US the cost of problems linked to drug use in the ambulatory setting exceeded

Incentives for orphan drug research and development in the United States

US177 billion in the year 2000.NSAIDs constitute a widely used class of drugs and they are one of the leading drug classes in causing adverse effects. The acquisition costs of the drugs, as well as the costs for prevention and treatment of adverse effects, determine their cost-effectiveness ratio. Depending on the incidence and severity of adverse effects, the cost per adverse effect avoided ranges from

Endoscopy-related infection: relic of the past?

US215 to

Exogenous endoscopy-related infections, pseudo-infections, and toxic reactions: clinical and economic burden

US35 459 (2000 values). According to the contingent valuation methodology, willingness to pay to avoid or reduce the incidence of adverse effects is an indicator of the value individuals associate with the impact of such effects on their well-being. Individuals are willing to pay annually an average of

Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980-2009

US240 and

Injury During U.S. Army Basic Combat Training A Systematic Review of Risk Factor Studies

US350, respectively, to avoid vomiting and gastrointestinal distress induced by NSAIDs.Although the results of the different studies reviewed are not strictly comparable because of differences in the severity of adverse effects, the perspective of the analysis, the cost data included and the cost component considered, the data show that, apart from the implications for health, a substantial quantity of resources are used to treat adverse effects.

Ethical imperatives of timely access to orphan drugs: is possible to reconcile economic incentives and patients' health needs?

Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009.

Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?

BackgroundThe Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007.MethodsPrimary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study period.ResultsThe FDA listed 1,793 orphan designations and 322 approvals between 1983 and 2007. Cancer was the main group of diseases targeted for orphan approvals. Eighty-three companies concentrated 67.7% of the total orphan NMEs approvals. The average time from orphan designation to FDA approval was 4.0 ± 3.3 years (mean ± standard deviation). The average maximum effective patent and market exclusivity life was 11.7 ± 5.0 years for orphan NME. OD market exclusivity increased the average maximum effective patent and market exclusivity life of ODs by 0.8 years.ConclusionPublic programs, federal regulations, and policies support orphan drugs R&D. Grants, research design support, FDA fee waivers, tax incentives, and orphan drug market exclusivity are the main incentives for orphan drug R&D. Although the 7-year orphan drug market exclusivity provision had a positive yet relatively modest overall effect on effective patent and market exclusivity life, economic incentives and public support mechanisms provide a platform for continued orphan drug development for a highly specialized market.

Drug utilization and cost in a Medicaid population: A simulation study of community vs. mail order pharmacy

Purpose of review Recent outbreaks of nosocomial infection and pseudoinfection have been linked to contaminated endoscopes. This review summarizes the recent literature, analyzes the latest published information related to the epidemiology, examines potential causes for the outbreaks, and discusses current alternatives for preventing infection. Recent findings A systematic follow-up of patients revealed that the risk of infection attributed to inadequate endoscope reprocessing was very low. Nevertheless, inadequate reprocessing practices are still considered the main culprit underlying contamination from endoscopy procedures. Moreover, standards of care are difficult to maintain given the numerous inconsistencies that exist among reprocessing guidelines and manufacturers recommended practices. Exposure to contaminated equipment could be prevented through better reprocessing practices and adherence to decontamination guidelines. Recent literature reinforces the need for endoscopy drying after each reprocessing cycle, endoscope reprocessing after short periods of disuse, surveillance, and for a coordinated approach to handle postcontamination responses. Additional analyses such as health technology assessment and cost analysis are needed to identify control alternatives that are most effective. Summary Although the risk of endoscopy-related infection is very low, continued efforts are needed to ensure that quality is maintained during endoscope reprocessing to reduce the incidence of endoscopy-related infections.