health needs. The medication-use system that is built on that foundation encompasses the continuum of (1) prescribing by the clinician (or self-prescribing), followed by transcribing; (2) preparing and dispensing by the pharmacist; (3) administering by the provider or consumer (self-care); and (4) monitoring for therapeutic and adverse effects (by nurse, surrogate, or self). Each of these steps includes critical control points at which decisions and actions can contribute to safety or errors. Figures 2-2, 2-3, and 2-4 outline these critical control points for the different health care settings.

The primary stakeholders involved in the medication-use system are patients/consumers and their families, providers, payers, regulators, employers, manufacturers, distributors, and policy makers. Secondary stakeholders include accrediting, patient safety, and quality improvement organizations; medical journal editors; and the general media. The dynamics of the system for medication delivery are shown, along with relevant stakeholders, in Figure 2-5.

Achieving safe and effective use of medications requires coordinated efforts by all stakeholders, with mutual recognition that each has unique perspectives on what constitutes appropriate or rational medication use (Knowlton and Penna, 2003). Patients/consumers and their families have an interest in maintaining their personal health and safety at a reasonable cost, as do their employers. Health care providers (physicians, nurse practitioners, physician assistants, nurses, pharmacists) have an interest in addressing patient problems effectively and achieving therapeutic objectives. Regulators have an interest in ensuring the safety of the general public and taking disciplinary action when necessary. Pharmaceutical manufacturers have an interest in developing and marketing new drugs in the service of society and their stockholders. Payers have an interest in providing their enrollees with insurance coverage at a reasonable cost (Knowlton and Penna, 2003). Community pharmacies and PBMs have an interest in providing patients and consumers with useful information about their medications and averting potential errors. Accrediting organizations have an interest in assessing health care providers’ compliance with medical safety standards and best practices. Patient safety reporting organizations have an interest in collecting data on events and developing protocols to improve safety. Medical journal editors have an interest in publishing comprehensive and accurate information about medications and their use. And the general media have an interest in writing newsworthy stories about health care and exposing any problems.

Unfortunately, the complex and diverse interests of the primary stakeholders have resulted in a medication-use system that is disjointed and inefficient in terms of manpower and resource consumption. Errors in medication delivery are the largest single category of medical errors in health care (IOM, 2000). Errors occur with all types of medications (e.g., pre-

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