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After completing this chapter, the reader will be able to

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  • Define adverse drug reactions.
  • Explain methods for determining the probability and causality of an adverse drug reaction.
  • Classify adverse drug reactions based on type and severity.
  • Describe examples of adverse drug reaction monitoring systems that have been implemented successfully.
  • Explain the use of technology in adverse drug reaction monitoring and reporting.
  • Use The Joint Commission and the American Society of Health-System Pharmacists guidelines to implement an adverse drug reaction reporting program.

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  • Image not available. An adverse drug reaction is any unexpected, unintended, undesired, or excessive response to a medicine.
  • Image not available. One of the first steps in establishing an ADR program is to define what the institution or facility categorizes as ADRs.
  • Image not available. Several algorithms have been published that try to incorporate information about an ADR into a more objective form.
  • Image not available. ADR surveillance serves primarily to provide early signals about possible problems.
  • Image not available. Communication is a critical component throughout the adverse drug reaction monitoring process.
  • Image not available. Technology plays an important role in monitoring, identifying, and minimizing adverse drug reactions.

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The terminology surrounding adverse drug reactions (ADRs) is often confusing. All adverse drug events (ADEs), ADRs, and medication errors fall under the umbrella of medication misadventures. Medication misadventure is a very broad term, referring to any iatrogenic hazard or incident associated with medications. An ADE is the next broadest term and refers to any injury caused by a medicine. An ADE includes all ADRs, such as allergic or idiosyncratic reactions, as well as medication errors that result in harm to a patient.1-5 ADRs and medication errors are the most specific terms. Image not available.ADRs refer to any unexpected, unintended, undesired, or excessive response to a medicine. A medication error is any preventable event that has the potential to lead to inappropriate medication use or patient harm.1Figure 15–1 shows one way of graphically classifying these terms. Many of these concepts will be explored in greater depth elsewhere in this text. This chapter focuses only on ADRs, highlighting pertinent definitions, classifications, reporting systems, and methods to minimize such events.

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Figure 15–1.
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Relationship among medication misadventures, adverse drug events, medication errors, and adverse drug reactions.(Adapted with permission from Bates DW, et al. Relationship between medication and errors and adverse drug events. J Gen Intern Med. 1995;April:10(4):199-205.)

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All medications, including the inactive ingredients of a product, are capable of producing adverse effects.6 Adverse drug reactions account for about 5% to 15% of all hospital admissions, cause patients to lose confidence in their health care providers, and lead to a significant increase in morbidity and mortality.7-11 This makes ADRs the fourth to sixth leading cause of death in the United States, just after heart disease.9

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ADRs have economic consequences as well. These reactions result in an annual cost of $5 to $7 billion to the ...

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