Preventing Medication Errors (2007) / Chapter Skim
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2 Overview of the Drug Development, Regulation, Distribution, and Use System
2 Overview of the Drug Development, Regulation, Distribution, and Use System
Pages 50-104
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Applied to this report, stakeholders of the drug system associated with research, innovation, regulation, clinical practice, payment, education, legislation, and reporting should be assessed according to how well quality and safety are (or can be) achieved, among other factors.
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. In 2004, 215 prescription and 71 OTC drugs were recalled because of manufacturing and distribution problems or serious adverse reactions (FDA, 2004a)
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52 Licensing Application; shortages supply Biologic Drug and Reimportation = New BLA PBMs and Distribution public, granted and drugs scale (generics) and samples, of Application; Investigational Review (new advertising surveillance = approval reimbursement AADA and doctors BLA product or Marketing, advertising and Drug to or biologics)
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In the first three of these examples, problems in the drug development, regulation, and distribution systems contribute to medication-use errors that should be corrected. Yet most links or components of the drug system operate in a quasi-silo state with less-than-ideal means of sharing important 1The Center for Drug Evaluation and Research (CDER)
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. Most often this is the case: medication errors are the result of a problem incurred during the prescribing, dispensing, administration, or monitoring phases of the medication-use system.
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. Trends in drug development over the past few decades have led to significant improvements in study designs, reducing the incidence of incorrect conclusions concerning dosage, efficacy, and safety while deepening understanding of how the molecular structures of potential new drugs interact with specific human cellular structures.
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During a January 2005 meeting on drug development science sponsored by the FDA and the Association of American Medical Colleges (AAMC) , participants from academia, industry, and government identified 5Pharmacodynamics denotes the biochemical and physiological effects of a drug and the relationship between drug concentration and effect.
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Each of the above factors can contribute to issues of patient safety and quality of care in the medication-use process. For example, drugs can produce very different effects in elderly patients and younger adults.
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. As genomics and proteomics enable drug development to become increasingly individualized, it will be possible to establish more specific benefit and risk assessments for particular patient populations with certain clinical or genetic characteristics.
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Postmarket Surveillance of New Drugs Some of the risks associated with a new drug are not known at the time of regulatory review because the data from clinical trials are limited in terms of patient population, study size, and/or duration. Consequently, drugs must continue to be evaluated as they are used in clinical settings to detect less frequent but significant adverse side effects, long-term effects, or effects in different patient populations.
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that provides information supporting equivalence to an FDA-approved brand-name drug in terms of active ingredients, dosage, safety, strength, administration, quality, performance, and intended use. Generic manufacturers are not required to replicate the extensive clinical trials of the original drug, but must demonstrate bioequivalence; this can be done by measuring bioavailability (e.g., rate and extent of absorption)
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in an effort to improve the quality of postmarket information about prescription drugs for health care providers and consumers. Also, there is renewed interest in earlier efforts to improve the design and content of consumer drug information distributed through the pharmacy (i.e., pharmacy leaflets)
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BOX 2-2 Summary of Key Problems with the Regulatory Review Process Affecting Safety and Quality in the Medication-Use System · Confusing presentation of important drug information in naming, labeling, and packaging can contribute to medication errors. · Procedures to address product labeling and packaging problems are cumbersome.
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From page 63... ...
Restrictive formularies or lack of drug coverage for prescribed medications can lead to prescription sharing among family and friends. Marketing practices and campaigns that overemphasize the benefits of a drug to providers and consumers without appropriate disclosure of its risks can lead to inappropriate prescribing and adverse drug effects.
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Most important from a consumer safety standpoint, in some instances, prescription drugs can be purchased without a prescription. Marketing to Consumers, Providers, and Payers Most stakeholders in the drug system are introduced to drug products for the first time through marketing and advertising campaigns.
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The impact of physicianpharmaceutical industry interactions is particularly concerning since these strategies are employed even for new drugs that may have little or no discernable advantage over existing drugs or other treatment options (Avorn, 2004) , and for which there may be only limited data from short-term clinical trials that may not have uncovered serious adverse effects (Califf and DeMets 2002a,b)
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. Unlike other nations that use formularies to determine access, payers in the United States maintain an open system to accommodate the broadest population and its potential medication needs; formularies for prescription drugs are used solely to determine tiered copayment and reimbursement structures, not access.
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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.
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(patient) Clinical Data entry and screening Verify instructions Self-monitor response decision making to medication Preparing, mixing, Prepare or Drug compounding measure dose Prescriber monitors choice for therapeutic Pharmacist Self-administer dose and adverse effects Drug double-check during follow-up regimen visit or call determination Dispense to consumer Documentation in Medical record medical record documentation by prescriber Order (written, If adverse drug event, verbal, or electronic)
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or no response Self-administer dose to medication, Consult with discontinue and either provider, make decision try another medication to medicate or go to doctor OTC product recommendation Feedback FIGURE 2-4 Medication-use process for over-the-counter drugs. Advice or medication Friend or Patient need Medication-use errors relative Patient communication Patient Follow-up & OTC seeks help outcomes Prescriber Physician PBM communication Assessment, Prescribing errors Rx claims Contact doctor diagnosis & adjudication for problems prescription & pro-DUR Local pharmacy Pharmacist DUR & screening Mail order Dispensing & Answer patient questions pharmacy Dispensing errors counseling Monitor outcome Specialty pharmacy Medication FIGURE 2-5 Dynamics of the medication-delivery system.
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Prescribing and Ordering The prescribing domain in community, hospital, and long-term care settings involves clinical decision making, selection of a drug and drug regimen, medical record documentation, and ordering. The clinician has the responsibility to engage the patient in discussion about the appropriateness of a prescription drug as part of the treatment plan and about how to design the regimen to meet the patient's needs.
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As another example, certain drugs, particularly antidepressants, analgesics, and muscle relaxants, are commonly and inappropriately prescribed for elderly patients, contributing to adverse drug events that necessitate health care services, physician contact, hospitalization, and emergency department visits (Golden et al., 1999; Hanlon et al., 2000a,b; Fick et al., 2004; Fialova et al., 2005)
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In 1990, the Omnibus Budget Reconciliation Act (OBRA) confirmed that "medically accepted indication" includes off-label use and should be supported by one of the following: · American Hospital Formulary Service drug information · American Medical Association drug evaluations · United States Pharmacopeia drug information · Scientific studies published in the peer-reviewed literature Estimates of off-label medication use range from 20 to 60 percent, depending on the drug and patient population (Dick et al., 2003; NCI, 2004; Murphy, 2005)
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While necessary, such methods can underscore the important differences between adults and children in develop ment and the metabolism and excretion of a particular drug, increasing the risk of an adverse drug event (Christensen et al., 1999; Jong et al., 2001)
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. Indeed, one study found that computerized provider order entry systems facilitated 22 different types of errors8 (Koppel et al., 2005)
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Transcription is the official term used to describe the complex set of tasks involved in interpreting and processing orders. Many medication errors are associated with the transcription process, particularly if a drug name looks or sounds like that of another drug or is illegible.
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Entry of orders into the pharmacy database system allows for automated screening of orders for therapeutic duplications, drug interactions, allergies, or doses that are not within an acceptable range; if therapeutically appropriate, screening the order against the patient's laboratory test results can avert potential adverse events (Manasse and Thompson, 2005)
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Finally, a growing number of community-based and most mail order pharmacies are using automated dispensing systems, including centralized systems that can produce unit doses (e.g., via strip or envelope packag 9An orphan drug is a product that is used in the diagnosis or treatment of diseases or conditions considered rare in the United States.
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In terms of mail order pharmacies, counseling is generally available as requested by telephone. Dispensing errors account for an estimated 612 percent of all medication errors (Buchanan et al., 1991; Allan et al., 1995; Flynn et al., 2003)
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. · Product labels are often read under less-than-ideal conditions, and the way a medication is packaged and labeled can have a significant impact on error rates.
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. While achieving the five rights is essential to safe medication administration, more complex factors must also be considered to ensure positive outcomes.
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Because medication administration is a high-volume activity, bar code medication administration systems can provide needed support to nurses during clinical care. They also generate data for the medication administration record (MAR)
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. Although most nursing shifts are 812 hours, mandatory overtime and double shifts contribute to nursing-related medication administration errors (IOM, 2004b)
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Self-Administration From the perspective of consumers, the most common types of medication errors are associated with administration of wrong dosages; unnecessary medicating; adverse drug reactions, including drugdrug interactions; and nonadherence. Errors occur from overdosing or underdosing as a result of inadequate instructions and use of inconsistent or improper measuring devices.
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. Monitoring for desired and undesired effects is a crucial step in the care process and in the prevention or detection of adverse drug events.
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. Electronic medical records with event-driven surveillance systems are able to monitor patients around the clock and have been shown to detect some adverse drug events early enough to prevent their progression from mild or moderate to severe (Classen et al., 1991; Evans et al., 1991, 1994; Jha et al., 1998; Bates and Gawande, 2003)
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. Another study of four primary care practices found that 25 percent of patients experienced an adverse drug event over a 3-month period (13 percent of these events were serious, 39 percent were preventable, and 6 percent were both serious and preventable)
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Self-monitoring of physiological and psychological responses to prescription drugs is even more critical to the identification of adverse events. Insufficient self-monitoring and nonadherence to drug regimens are well
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Conversely, several studies have noted certain individuals' ability, given adequate education, to participate successfully in self-care and disease management for various health conditions, including diabetes, which requires frequent self-monitoring of blood glucose levels to make adjustments in self-administered insulin therapy; depression, which requires selfassessment of changes in psychosocial affect resulting from prescribed medications; and cancer, which requires self-monitoring of adverse reactions to powerful chemotherapy agents (Grissinger et al., 2003; Ikesue et al., 2004; Schroeder et al., 2004)
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These reporting programs include the following: · Institutional error reporting programs such as the Veterans Administration Patient Safety Reporting System and the U.S. Pharmacopeia's MedMARx Program.
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Preparing and Dispensing · Problems with sound-alike drug names and look-alike drug names and packaging · Stressful and distracting work environments Administration and Monitoring · Lack of timely access to knowledge at the point of care (e.g., drug or patient history or laboratory information) · Lapses in performance (e.g., memory, adherence to guidelines, slips)
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There is anecdotal evidence that the Joint Commission on Accreditation of Health Care Organizations' Sentinel Event Reporting System and the U.S. PharmacopeiaInstitute for Safe Medication Practice Medication Errors Reporting Program have led to important safety improvements (Leape, 2002)
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The consumer version of the system, MedWatch Plus, is designed to collect direct reports from consumers who have experienced an adverse drug reaction (Behrman, 2005)
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. Through NEISS-CADES, the CDC conducts nationally repre sentative surveillance for adverse drug events (ADEs)
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1995. Incidence of adverse drug events and potential adverse drug events.
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2005. Emergency department visits for outpatient adverse drug events: Demonstration for a national surveillance system.
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2005. Overview of the Institute for Safe Medication Practice and Reported Adverse Drug Events.
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2004. Pharmacist surveillance of adverse drug events.
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2000. Incidence and preventability of adverse drug events in nursing homes.
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1998. Identifying adverse drug events: Development of a computer-based monitor and comparison with chart review and stimulated voluntary report.
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1995. Systems analysis of adverse drug events.
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Washington, DC: IOM Committee on Identifying and Preventing Medication Errors. NABP (National Association of Boards of Pharmacy)
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2005. Community Pharmacy Perspectives on Preventing Medication Errors at the July 6, 2005, Meeting of the IOM Committee on Identifying and Preventing Medication Errors, Washington, DC.
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2004. Potential conflict of interest in the evaluation of suspected adverse drug reactions.
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1999. Under standing and comparing differences in reported medication administration error rates.
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