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Informing the Future Critical Issues in Health: Fourth Edition (2007) / Chapter Skim
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Pharmaceuticals: The Good and the Bad
Pages 13-18

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From page 13...
... -- Jerry Avorn, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs The pharmaceutical industry highlights the complexity of the health care system and its interactions. Academics, manufacturers, research scientists, patient advocates, and customers all play a role, and the issues surrounding the development, regulation, marketing, and use of pharmaceuticals are often contentious.
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From page 14...
... When all types of errors are taken into ac count, the average hospital patient can expect to be subject ed to at least one medication error per day. While only a frac tion of these errors are significantly harmful to the patient, the report estimated that the costs of treating drug-related injuries in hospitals alone were $3.5 billion a year, not includ ing lost wages, lost productivity, or additional health care costs.
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From page 15...
... Manufacturing, Marketing, and Distribution Reimportation and long term, self-care) supply shortages • Physician prescribing and self- • FDA inspection Documentation prescribing • Production to economies of scale • Dispensing • Shipment to wholesalers • Administration and consumption • Shipment to pharmacies • Monitoring for effects • Payer formulary and reimbursement and PBMs • Reporting errors and adverse effects Journal articles, academic investigators, accreditation organizations, media, patient safety organizations Marketing to doctors and public, Postmarket surveillance distributing product samples, studies of medication use DTC advertising Figure 2.1 Four stages of the drug system.
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From page 16...
... These safety is sues have had tremendous costs, both in dollars and, far more importantly, in lives lost or persons harmed by the drugs. The IOM committee recommended that the FDA's au thority to successfully monitor postmarket safety be clari fied and their resources and expertise strengthened to en able effective surveillance and rapid action when problems are identified.
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From page 17...
... It continues today to inform the debate over post-approval drug surveillance in both the House and the Senate. In addition to these studies, the IOM has organized roundtables, forums, and public workshops that provide opportunities for government, academic, industry, and consumer experts to meet and share knowledge on critical issues (see Chapter 9)
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