Background for

Action Agenda Consensus Process

Primary References

Gurwitz, JH, et al., Incidence and Preventability of Adverse Drug Events Among Older Persons in the Ambulatory Setting, JAMA. 289:1107-1116, March 5, 2003.

Classen, D, Medication Safety: Moving from Illusion to Reality, JAMA, 289:1154-1156, March 5, 2003.

Ghandi, TK, et al., Adverse Drug Events in Ambulatory Care, NEJM, 348(16):1556-1564, April 17, 2003.

Tierney, WM, Adverse Outpatient Drug Events — A Problem and an Opportunity, NEJM 348(16):1556-1564, April 17, 2003.

Patient Safety: Problem Targets

Gurwitz

• Electrolyte/renal, gastrointestinal tract, hemorrhagic and metabolic endocrine events were the most common types of preventable adverse drug events identified. (Gurwitz)

• The types of medications most commonly involved in adverse drug events relate closely to those most frequently prescribed in the ambulatory setting, with cardiovascular drugs and antibiotics/anti-infectives being the most frequently used and implicated drug categories. (Gurwitz)

• Anticoagulants were responsible for 121 of the 1523 adverse drug events, fully a third of which were considered preventable. (Gurwitz)

• While most errors occurred at the prescribing and monitoring stages, problems with patient adherence were cited as a contributing factor in more than 20% of the cases. Errors included taking the wrong dose, continuing to take medication physician’s instructions to discontinue, refusal to take needed medication, continuing to take medication despite recognizable adverse effects or drug interactions, taking another person’s medication. (Gurwitz)

• Wrong drug/wrong therapeutic choice errors were most common among the 421 preventable adverse drug events, followed by wrong dose errors. (Gurwitz)

• Inadequate patient education concerning medication use was cited as an error in 18% of preventable adverse drug events. (Gurwitz)

• Prescription of a drug for which there was a well-established, clinically important interaction with another drug (e.g. drug interaction with warfarin) was also a common error. (Gurwitz)

• Monitoring stage errors generally represented inadequate laboratory monitoring of drug therapies or a delayed response or failure to respond to signs or symptoms of drug toxicity or laboratory evidence of drug toxicity. (Gurwitz)

Classen

• Most frequent classes of drugs associated with adverse drug events were cardiovascular agents, antibiotics, diuretics, nonopioid analgesics and anticoagulants. (Classen)

• Lack of patient adherence known to be associated with therapeutic failure, also found to pose a safety risk. (Classen)

Ghandi

• The medication classes most frequently involved in adverse drug events were selective serotonin-reuptake inhibitors (10 percent), beta-blockers (9 percent), angiotensinconverting –enzyme inhibitors (8 percent), and nonsteroidal antiinflammatory agents (8 percent). (Ghandi)

• The most frequent type of adverse drug events and the most frequent preventable or ameliorable events were those related to the central nervous system (33 percent and 35 percent, respectively), gastrointestinal events (22 percent and 25 percent), and cardiovascular events (18 percent and 18 percent). (Ghandi)

• The number of medications that a patient took was associated with the risk of an event (P<0.001). The mean number of events per patient increased by 10 percent (95 percent confidence interval, 6 to 15 percent) for each additional medication. (Ghandi)

• Preventable adverse drug events were due to prescribing errors, one third of which could have been prevented by the use of computerized checks for interactions and allergies. (Ghandi)

• Ameliorable adverse drug events were attributed to poor communication: the physician’s failure to respond to symptoms reported by the patient or the patient’s failure to report symptoms to the physician. Patients often had symptoms for months without any changes in their medications, and only a small percentage reported that symptoms led to a visit to a physician. (Ghandi)

Tierney

• Errors of omission (i.e., missed opportunities to prescribe appropriate medications) may be even more common, and their adverse effects may be huge. Repeated studies have shown that at time of hospital discharge, many patients with myocardial infarction are not prescribed beta blockers or aspirin, despite evidence these reduce morbidity and mortality. (Tierney)

Patient Safety: Action Opportunities

Identifying, Measuring the Problem

• Enhanced surveillance and reporting systems for adverse drug events in the ambulatory setting are required. (Gurwitz, Classen)

• Better research on the nature of adverse drug events in the outpatient setting, where most medications are prescribed. (Tierney)

• Improved strategies to monitor side effects could also be developed; for example, a nurse or pharmacist could call the patient after an office visit to inquire about any problems related to medications. (Ghandi)

• Outpatient practices could routinely screen patients for potential drug-related symptoms while the patients were in the waiting room, perhaps by using mobile computing devices, so that physicians would be alerted to a potential drug-related problem during the patient’s visit, when it could be addressed most effectively. (Tierney)

• Further research should focus on why patients do not report symptoms to physicians and why physicians fail to act on the reports they do receive. (Ghandi)

Patient Education/Involvement

• Patient education as an essential component of most efforts to improve patient use of pharmaceuticals and patient adherence. (Gurwitz)

• Increased involvement of older persons and caregivers, when appropriate, in their pharmaceutical care. (Gurwitz)

• Patient non adherence may be remedied through patient education, but commonly used approaches are not effective. Novel new methods to involve patients more directly in all aspects of their care are needed. (Classen)

• Web pages for patients to supplement information from doctor; if personalized, how to protect privacy and security. (Gurwitz)

• Strategies to improve doctor/patient communications: educational materials for patients, improving translation services, increasing patients’ access to outpatient pharmacists and other health professionals, websites for patients. (Ghandi)

• Improved communication between outpatients and physicians may reduce the frequency of adverse events. (Ghandi)

• Education about these commonly prescribed medications (antidepressant and antihypertensive) and increased monitoring for side effects could benefit physicians and patients. (Ghandi)

Electronic Approaches

• Electronic approaches (for detecting adverse drug events) include searching for triggers such as abnormal laboratory test results and pharmacy information, the administration of known antidotes, the use of diagnostic codes and structured documentation related to ADEs, and the use of free text searching of text based clinical notes. (Classen)

• Physicians need to use computer-based order-entry systems to prevent adverse events caused by illegible handwriting, inappropriate doses, drug interactions, and allergies. (Tierney)

• A forthcoming Leapfrog standard will encompass ambulatory electronic prescribing of medications with decision support and electronic laboratory results review. (Classen)

• Reliable, regularly updated decision support systems and information technology; i.e., computerization of prescribing with decision support and active prompting of the prescriber to perform follow-up laboratory testing. (Gurwitz, Classen)

• More timely collaboration between the scientists who study drug-drug and food-drug interactions and those who design computer systems intended to prevent them. (Ghandi)

Physicians

• Physicians’ responses to symptoms could be improved by making physicians more aware of the importance of monitoring the prevalence and burden of adverse drug events among outpatients, and the range of therapeutic alternatives. (Ghandi)

Pharmacists

• Enhance collaboration between those who prescribe drugs and those who know the most about specific drugs, that is, clinical pharmacists. (Gurwitz)

• Clinical pharmacist consultation services. (Classen)

• Pharmacists should routinely inquire about drug-specific and nonspecific symptoms, instead of merely asking patients, “Do you have any questions?” In addition, pharmacists and physicians should collaborate to improve pharmacotherapy. (Tierney)

• Pharmacists could also collaborate with physicians on individualized (“N of 1”) trials, which can help determine whether non specific symptoms can be attributed to specific drugs. (Tierney)

Drug/Event Specific

• If overuse of antibiotics were addressed, many ADEs caused by antibiotics might be prevented. (Classen)

• Several interventions have been demonstrated to improve ambulatory drug use in older persons, including curbing overuse of medications by identifying inappropriate medications and stopping their use and addressing underuse of beneficial medications. (Classen)

• More systematic approach to decision making about the use of warfarin, for example, for stroke prevention in older persons. (Gurwitz)

• More widespread use of specialized clinics for anticoagulation therapy. (Gurwitz, Classen)

• More rigid scrutiny of decisions to implement antibiotic therapy. (Gurwitz)