Bibliography

SOS Rx Action Agenda Consensus Retreat

2003

Rucker L. “Risk, Respect, Responsibility”: Educational Strategies to Promote Safe Medicine Use. Journal of Medical Systems December 2003 27(6): 519-530

Nearly four billion outpatient prescriptions will be dispensed in the United States by 2005. Many people using these medicines will be targeted for educational programs promoting their safe, appropriate use. Such programs have been, or soon will be, developed by virtually all major health care system stakeholders, including: government agencies, the pharmaceutical industry, non-profit organizations and coalitions. After examining changes in 1) health professionals' communication of patient medicine information, and 2) consumers' roles and attitudes, an overview of recent U.S. and international consumer education programs is presented. Despite the proliferation of these programs, most share a weak link in evaluating success and in affecting behavior change. Finally, suggestions for future initiatives are offered, particularly regarding improving evaluation methods.

Awe C; Lin S. A patient empowerment model to prevent medication errors. Journal of Medical Systems December 2003 27(6): 503-517

Each year, untold deaths occur because of medical and medication errors in the United States. In generally, most people have the naïve perception that the health-care enterprise is a fail-safe system and as such do not take proactive measures to prevent potential medication errors. This paper is timely in light of the proliferation of medication use in outpatient settings and thus warrants the education of patients to take the responsibility in proper drug use. Patients and the health-care professionals must understand the need to see patients as part of the health-care team to ensure quality of care and decrease medication errors. A patient empowerment model to prevent medication error is therefore proposed.

Marchev M; Rosenthal J; Booth M. How states report medical errors to the public: issues and barriers. October 2003 Journal of Health Politics, Policy and Law

As part of a comprehensive strategy to improve patient safety, the Institute of Medicine (IOM) has called for the creation of external reporting systems to identify and learn from errors so as to prevent future occurrences. The IOM has maintained that the public has a right to be informed of unsafe conditions and that, in the case of serious adverse events, disclosure to the public is an appropriate and desirable practice.

Twenty-one states currently have mandatory reporting systems, but releasing adverse event and medical error data to the public continues to be sporadic and inconsistent across the systems.

Interviews with officials in states with mandatory reporting systems suggest that states continue to face a number of challenges in their efforts to report medical errors to the public. The challenges are complex and multifaceted, often pitting the public’s right and need to know against privacy concerns.

This report is designed to assist states in their efforts to disclose important information to the public. It begins by looking at what a state might disclose and then examines the barriers that exist to disclosure and how these barriers might be overcome with appropriate data protections. Among the key findings of this report:

· There is no evidence to show what level of data disclosure advances the patient safety agenda. More research is needed in order for state officials to be able to make informed decisions and not act simply on gut feelings, anecdote, and/or pressure from interest groups.

· Under reporting is a serious issue. State systems are not as useful as they could be because under reporting limits the accuracy of data analysis and may result in public reports that are misleading. States are hesitant to release data that the public might misunderstand or that unfairly punishes compliant reporters.

· The reasons for under reporting are numerous and include facilities’ lack of internal systems to identify events, uncertainty about reporting requirements, a culture of non-reporting, a lack of enforcement at the state level, bureaucratic burden, competition and market share, fear of publicity, and fear of liability. It is simplistic to assume reporting would increase if data were protected; however, some degree of protection may be necessary to create an environment conducive to reporting.

· The trend among states introducing new mandatory systems is to: a) establish them in statute, as opposed to regulation, b) offer strong comprehensive protection of reported data, and c) release data only in aggregate form.

· Seven of the 21 states with mandatory reporting systems release incident specific data. Fourteen states currently issue or plan to issue aggregate reports. Of these, five states have or plan to issue aggregate reports with individual facilities identified.

· Recognizing that there will probably always be some level of under reporting and consumers may not be able to make selections based on the data, an advisory group to this report believed public reporting can still fulfill a variety of goals, including regulatory accountability and the detection of trends.

· States may choose not to disclose their mandatory reporting data or may not make data easily accessible to the public. Incident-specific data are most commonly provided on a request only basis. In several states, where information is available to the public, it is often difficult to access or requires an intricate understanding of how and where to request the information in order to access it. The data may be provided in a raw form without accompanying analysis to assist with interpretation.

· Patient safety event data require careful analysis and interpretation before they are useful to the public.

· Besides mandatory reporting information, other types of patient safety information may be available through state agencies. Patient safety reporting is not intended to replace these other sources of data which may be less protected.

· States need resources to improve their systems in order to meet public expectations of a patient safety system. While the Institute of Medicine recommended that funds be provided to states to create reporting systems, funds are not now available. In some states data that would otherwise have been analyzed and released to the public have not been because of a lack of resources. In other states, reporting systems have been established by law but are not operating due to lack of funds.

Britten N. Does a prescribed treatment match a patient’s priorities? BMJ Oct 11 2003;327:840

Within the past 10 years several studies carried out in different settings have investigated patients' perceptions of prescribed drugs. Most of these studies have been qualitative and relatively small scale. They have all revealed considerable ambivalence about drug taking. This study by Townsend and colleagues confirms the validity of these findings for a community based sample of middle aged people in Scotland with multiple morbidities and provides a rich description of the different aspects of this ambivalence. Most prescribed drugs are taken by elderly people with chronic conditions.

This study also helps to explain quantitative research that has identified core beliefs about the perceived necessity of taking prescribed drugs as well as concerns about potential harms.¹ It shows the futility of labelling patients as "compliers" or "non-compliers," as the same person may take one drug regularly while altering the dose or frequency of another. The paper shows the ambiguous yet powerful impact of drug taking on people's identity and the efforts that people make to fulfil their family and social obligations. Above all, the paper reveals the centrality of the notion of self regulation of prescribed drugs, in which patients organise their drug taking around their own priorities.

Patients' priorities may therefore be very different from prescribers' priorities, or indeed from the priorities that prescribers assume their patients to have. This paper shows clearly that patients' moral concerns and the demands of their social roles are often more important for them than the alleviation of symptoms or the cure of disease. For people struggling to retain their social identity, the issue of compliance may not be high on their agenda. Clinicians who are trying to give their patients the best evidence about treatment options and to present balanced information about risks and benefits may find it difficult to take this on board.

Dickinson D; Raynor DK. Ask the patients—they may know more than you think. BMJ Oct 11 2003;327:861

What information do patients need about medicines? Partnership between health professionals and patients depends, in part, on the provision and exchange of accurate and reliable information about drugs, but who should provide it? We invited contributors to answer the question from the perspectives of patients, clinicians, and the pharmaceutical industry

People's appetite for information about their treatment is often greater than doctors believe.¹ Clearly, patients vary in the extent of their desire for partnership in making medical decisions. It follows that part of the duty of a health professional is to work out how much partnership a patient wants, and what information he or she needs to support that level of partnership.

What do people want to know?

People have a broad range of information preferences that may differ at different times and for different reasons. They may want more information than prescribers want to give—for example, about the possible side effects of a drug. They may place different interpretations on information about likely risks, and they may question the benefits of taking a drug when they are not greatly concerned by the medical "problem" that the treatment is meant to solve. They may well rate the practicalities of how to take a drug higher than the details of the inert components of the pills or the drug manufacturer's address.

In interviewing people about drug treatments, we have consistently noticed that people respond to four essential aspects of a drug:

· Side effects

· What it does and what it's for

· Do's and don'ts

· How to take it.

Who is trusted as a source of information?

Our work with medicine users shows clear trends, in common with consumer surveys:

· Health professionals are the most popular source for drug advice

· Electronic media (internet and television) are becoming important sources

· Non-expert help (such as friends and family) is always popular.

A range of information sources is preferred, but that doesn't challenge health professionals' premier position. Lay or non-expert sources are generally used to help people fit expert information into their everyday life or to fill the gaps after a consultation that left certain questions unanswered.

It follows that the ideal source of drug information would be

· Accurate, up to date, reliable, and practically useful

· Accessible in language, format, and tone

· Capable of customisation or personalisation

· Available at different levels of detail at different times

· Informative about conditions as well as treatments

· Striking a balance between a treatment's beneficial and adverse effects

· Available at the time of a consultation and consistent with best advice

· Linked to other reliable and consistent sources of advice and information.

A structured source of information to enable better use of drugs in Britain is being piloted as part of "Ask about medicines week." Under the guidance of an advisory board that includes representatives of patients, health professionals, regulatory authorities, and the drug industry, new sources of information have been drafted. Medicine guides—practical online guides to individual drugs—are linked to new content on NHS Direct Online about the conditions being treated. The pilot project covers epilepsy and colds and flu. The aim of the project is to provide access to consistent, high quality, multilevel patient information that complements the detailed information leaflets contained in most drug packs. This information should eventually be accessible in multiple media and could be used by doctors, nurses, and pharmacists for personalised counselling whenever drugs are prescribed or dispensed.

Elwyn G; Edwards A; Britten N. “Doing Prescribing”: how doctors can be more effective. BMJ Oct 11 2003;327:864-867

What is the best way to achieve concordance? The authors summarise the evidence and indicate the way ahead for doctors to involve patients in making decisions about treatment.

Much prescribed medicine is not taken, and we know that few patients adhere to "prescription" guidance. It is also clear that patients' beliefs and attitudes influence how they take drugs. This is particularly true for preventive medicine (thus largely for conditions without symptoms) and for drugs that have side effects or other drawbacks. As interest in the concept of patient autonomy increases, we are becoming more aware, and more respectful, of intentional dissent—where better informed patients decline certain drugs. Concordance describes the process whereby the patient and doctor reach an agreement on how a drug will be used, if at all. In this process doctors identify and understand patients' views and explain the importance of treatment, while patients gain an understanding of the consequences of keeping (or not keeping) to treatment.

Few well-conducted, randomised controlled trials of interventions to help patients follow their prescriptions have been done. Our article is based on a number of reviews in this field and a recent systematic review of concordance. Changes in terminology in this area have mirrored an increasing rejection of the power relation implicit in the term "to prescribe." The authority laden term "compliance" gave way to the view that patients "adhered" (or not) to treatment. Recently the term concordance has been used to describe an agreed plan between patient and doctor about the use of treatment—one of the results of a shared decision making process.

Murray MD; Callahan CM. Improving medication use for older adults: an integrated research agenda. Ann Intern Med 2003 Sep 2;139(5 Pt 2):425-9

Effective health care is a core determinant of successful aging, and medications are one of the most important therapeutic tools of health care providers. Most older adults use at least one prescription drug. Costs for these drugs are a substantial out-of-pocket expense for Medicare beneficiaries, and low-income older adults must weigh these costs against those of other basic needs. Although medications bring welcome relief to millions of elderly persons with age-related conditions, adverse drug events are an important cause of illness and death in these patients. Thus, the appropriate, cost-effective use of medication is central to successful aging. Despite increasing attention to geriatric pharmacotherapy, there is an enormous need for additional research to improve the use of medications among older adults. The necessary research agenda encompasses much more than just the discovery of new drugs; better use of the current pharmacopeia has great potential to improve the lives of older adults. We review four domains of pharmaceutical research: drug discovery and delivery, drug efficacy and safety, pharmacoepidemiology and drug policy, and improved access to and use of drugs. These domains encompass both the pre- and postmarketing phases of drug research. Premarketing research currently has greater magnitude and a better infrastructure than postmarketing research, yet issues arising in the two phases of research are equally important to the health and safety of older adults. A national, federally supported pharmaceutical database could greatly enhance the infrastructure of postmarketing research. However, many major improvements in medication use among older adults will also depend on closing the gap between knowledge and practice and increasing the ability of older adults to manage their medications.

Bates DW, Gawande AA. Improving safety with information technology. N Engl J Med June 19 2003;348:2526-2534.

Health care is growing increasingly complex, and most clinical research focuses on new approaches to diagnosis and treatment. In contrast, relatively little effort has been targeted at the perfection of operational systems, which are partly responsible for the well-documented problems with medical safety. If medicine is to achieve major gains in quality, it must be transformed, and information technology will play a key part, especially with respect to safety.

Tierney WM. Adverse Outpatient Drug Events—A Problem and Opportunity

NEJM 348(16):1556-1564, April 17, 2003

On the day I was asked to write this editorial, my 80-year-old father had a nearly fatal adverse drug event. His physicians had attributed the nonspecific symptoms to his Parkinson's disease and had increased his dose of levodopa–carbidopa. His physical and cognitive function continued to worsen, until hallucinations, chorioform movements, and blepharospasm characteristic of levodopa–carbidopa toxicity developed and he became bedridden. The drug was stopped, and his condition improved dramatically over the ensuing 48 hours; he became ambulatory and regained his base-line mental status. This incident had many of the typical features of adverse drug events.

Gandhi TK, Weingart SN, Borus J, et al. Adverse drug events in ambulatory care. N Engl J Med April 17 2003;348:1556-1564.

BACKGROUND: Adverse events related to drugs occur frequently among inpatients, and many of these events are preventable. However, few data are available on adverse drug events among outpatients. We conducted a study to determine the rates, types, severity, and preventability of such events among outpatients and to identify preventive strategies. METHODS: We performed a prospective cohort study, including a survey of patients and a chart review, at four adult primary care practices in Boston (two hospital-based and two community-based), involving a total of 1202 outpatients who received at least one prescription during a four-week period. Prescriptions were computerized at two of the practices and handwritten at the other two. RESULTS: Of the 661 patients who responded to the survey (response rate, 55 percent), 162 had adverse drug events (25 percent; 95 percent confidence interval, 20 to 29 percent), with a total of 181 events (27 per 100 patients). Twenty-four of the events (13 percent) were serious, 51 (28 percent) were ameliorable, and 20 (11 percent) were preventable. Of the 51 ameliorable events, 32 (63 percent) were attributed to the physician's failure to respond to medication-related symptoms and 19 (37 percent) to the patient's failure to inform the physician of the symptoms.The medication classes most frequently involved in adverse drug events were selective serotonin-reuptake inhibitors (10 percent), beta-blockers (9 percent), angiotensin-converting-enzyme inhibitors (8 percent), and nonsteroidal antiinflammatory agents (8 percent). On multivariate analysis, only the number of medications taken was significantly associated with adverse events. CONCLUSIONS: Adverse events related to drugs are common in primary care, and many are preventable or ameliorable. Monitoring for and acting on symptoms are important. Improving communication between outpatients and providers may help prevent adverse events related to drugs.

Bates DW, Evans RS, Murff H, Stetson PD, Pizziferri L, Hripcsak G. Detecting adverse events using information technology. J Am Med Inform Assoc. Mar-Apr 2003. Available as a preprint: http://www.jamia.org/cgi/content/abstract/m1074v1. Accessibility verified February 17, 2003.

CONTEXT: Although patient safety is a major problem, most health care organizations rely on spontaneous reporting, which detects only a small minority of adverse events. As a result, problems with safety have remained hidden. Chart review can detect adverse events in research settings, but it is too expensive for routine use. Information technology techniques can detect some adverse events in a timely and cost-effective way, in some cases early enough to prevent patient harm. OBJECTIVE: To review methodologies of detecting adverse events using information technology, reports of studies that used these techniques to detect adverse events, and study results for specific types of adverse events. DESIGN: Structured review. METHODOLOGY: English-language studies that reported using information technology to detect adverse events were identified using standard techniques. Only studies that contained original data were included. MAIN OUTCOME MEASURES: Adverse events, with specific focus on nosocomial infections, adverse drug events, and injurious falls. RESULTS: Tools such as event monitoring and natural language processing can inexpensively detect certain types of adverse events in clinical databases. These approaches already work well for some types of adverse events, including adverse drug events and nosocomial infections, and are in routine use in a few hospitals. In addition, it appears likely that these techniques will be adaptable in ways that allow detection of a broad array of adverse events, especially as more medical information becomes computerized. CONCLUSION: Computerized detection of adverse events will soon be practical on a widespread basis.

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

The importance of medication safety has been recognized for many years, but only recently has it reemerged as a major public health issue based on numerous recent studies and high-profile safety events. Drug safety dates back to the 1950s, when in response to reports of chloramphenicol-associated aplastic anemia, the American Medical Association established an adverse drug reaction (ADR) reporting system and the Food and Drug Administration began requiring pharmaceutical manufacturers to report ADRs. This effort to detect heretofore unknown, serious adverse effects of medications in postmarket use relied on voluntary reporting, which also became common practice in most health care organizations.

In the 1960s, Jick and colleagues began to focus on the safety of drugs in everyday practice, using a concurrent study approach instead of voluntary reporting. The authors found that 30% of the medical inpatients in their study experienced at least 1 ADR during their hospital stay, and 3% of hospitalizations were directly attributable to ADRs. They also estimated that 29 000 deaths due to ADRs occurred annually in the United States. However, adverse effects of drugs were viewed as an unavoidable part of modern medical therapy; in a later publication, Jick noted that "the rates and severity of adverse reactions to individual drugs are remarkably low in view of their pharmacological properties."

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

CONTEXT: Adverse drug events, especially those that may be preventable, are among the most serious concerns about medication use in older persons cared for in the ambulatory clinical setting. OBJECTIVE: To assess the incidence and preventability of adverse drug events among older persons in the ambulatory clinical setting. DESIGN, SETTING, AND PATIENTS: Cohort study of all Medicare enrollees (30 397 person-years of observation) cared for by a multispecialty group practice during a 12-month study period (July 1, 1999, through June 30, 2000), in which possible drug-related incidents occurring in the ambulatory clinical setting were detected using multiple methods, including reports from health care providers; review of hospital discharge summaries; review of emergency department notes; computer-generated signals; automated free-text review of electronic clinic notes; and review of administrative incident reports concerning medication errors. MAIN OUTCOME MEASURES: Number of adverse drug events, severity of the events (classified as significant, serious, life-threatening, or fatal), and whether the events were preventable. RESULTS: There were 1523 identified adverse drug events, of which 27.6% (421) were considered preventable. The overall rate of adverse drug events was 50.1 per 1000 person-years, with a rate of 13.8 preventable adverse drug events per 1000 person-years. Of the adverse drug events, 578 (38.0%) were categorized as serious, life-threatening, or fatal; 244 (42.2%) of these more severe events were deemed preventable compared with 177 (18.7%) of the 945 significant adverse drug events. Errors associated with preventable adverse drug events occurred most often at the stages of prescribing (n = 246, 58.4%) and monitoring (n = 256, 60.8%), and errors involving patient adherence (n = 89, 21.1%) also were common. Cardiovascular medications (24.5%), followed by diuretics (22.1%), nonopioid analgesics (15.4%), hypoglycemics (10.9%), and anticoagulants (10.2%) were the most common medication categories associated with preventable adverse drug events. Electrolyte/renal (26.6%), gastrointestinal tract (21.1%), hemorrhagic (15.9%), metabolic/endocrine (13.8%), and neuropsychiatric (8.6%) events were the most common types of preventable adverse drug events. CONCLUSIONS: Adverse drug events are common and often preventable among older persons in the ambulatory clinical setting. More serious adverse drug events are more likely to be preventable. Prevention strategies should target the prescribing and monitoring stages of pharmaceutical care. Interventions focused on improving patient adherence with prescribed regimens and monitoring of prescribed medications also may be beneficial.

2002

McDonald HP; Garg AX; Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA 2002 Dec 11;288(22):2868-79

CONTEXT: Low adherence with prescribed treatments is ubiquitous and undermines treatment benefits. OBJECTIVE: To systematically review published randomized controlled trials (RCTs) of interventions to assist patients' adherence to prescribed medications. DATA SOURCES: A search of MEDLINE, CINAHL, PSYCHLIT, SOCIOFILE, IPA, EMBASE, The Cochrane Library databases, and bibliographies was performed for records from 1967 through August 2001 to identify relevant articles of all RCTs of interventions intended to improve adherence to self-administered medications. STUDY SELECTION AND DATA EXTRACTION: Studies were included if they reported an unconfounded RCT of an intervention to improve adherence with prescribed medications for a medical or psychiatric disorder; both adherence and treatment outcome were measured; follow-up of at least 80% of each study group was reported; and the duration of follow-up for studies with positive initial findings was at least 6 months. Information on study design features, interventions, controls, and findings (adherence rates and patient outcomes) were extracted for each article. DATA SYNTHESIS: Studies were too disparate to warrant meta-analysis. Forty-nine percent of the interventions tested (19 of 39 in 33 studies) were associated with statistically significant increases in medication adherence and only 17 reported statistically significant improvements in treatment outcomes. Almost all the interventions that were effective for long-term care were complex, including combinations of more convenient care, information, counseling, reminders, self-monitoring, reinforcement, family therapy, and other forms of additional supervision or attention. Even the most effective interventions had modest effects. CONCLUSIONS: Current methods of improving medication adherence for chronic health problems are mostly complex, labor-intensive, and not predictably effective. The full benefits of medications cannot be realized at currently achievable levels of adherence; therefore, more studies of innovative approaches to assist patients to follow prescriptions for medications are needed.

Bull SA; Hu XH; Hunkeler EM; Lee JY; Ming EE; Markson LE; Fireman B. Discontinuation of use and switching of antidepressants: influence of patient-physician communication. JAMA 2002 Sep 18;288(11):1403-9

CONTEXT: Although current depression treatment guidelines recommend continuing antidepressant therapy for at least 4 to 9 months, many patients discontinue treatment prematurely, within 3 months. OBJECTIVES: To investigate the relationship between patient-physician communication and the continuation of treatment with antidepressants and to explore the demographics, adverse effects, therapeutic response, and frequency of follow-up visits. DESIGN, SETTING, AND PATIENTS: A total of 401 telephone interviews of depressed patients being treated with selective serotonin reuptake inhibitor (SSRI) therapy between December 15, 1999, and May 31, 2000, were conducted and 137 prescribing physicians completed written surveys from Northern California Kaiser Permanente health maintenance organization outpatient clinics. MAIN OUTCOME MEASURES: Patient-physician communication about therapy duration and about adverse effects; therapy discontinuation or medication switching within 3 months after start of SSRI therapy. RESULTS: Ninety-nine physicians (72%) reported that they usually ask patients to continue using antidepressants for at least 6 months, but 137 patients (34%) reported that their physicians asked them to continue using antidepressants for this duration and 228 (56%) reported receiving no instructions. Patients who said they were told to take their medication for less than 6 months were 3 times more likely to discontinue therapy (odds ratio [OR], 3.12; 95% confidence interval [CI], 1.21-8.07) compared with patients who said they were told to continue therapy longer. Patients who discussed adverse effects with their physicians were less likely to discontinue therapy than patients who did not discuss them (OR, 0.49; 95% CI, 0.25-0.95). Patients who reported discussing adverse effects with their physicians were more likely to switch medications (OR, 5.60; 95% CI, 2.31-13.60). Fewer than 3 follow-up visits for depression, adverse effects, and lack of therapeutic response to medication were also associated with patients' discontinuing therapy. CONCLUSIONS: Discrepancies exist between instructions that physicians report they communicate to patients and what patients remember being told. Explicit instructions about expected duration of therapy and discussions about medication adverse effects throughout treatment may reduce discontinuation of SSRI use. Our finding that patients with 3 or more follow-up visits were more likely to continue using the initially prescribed antidepressant medication suggests that frequent patient-physician contact may increase the probability that patients will continue therapy.

Phelan EA; Williams B; Leveille S; Snyder S; Wagner EH; Lo Gerfo JP. Outcomes of a community-based dissemination of the health enhancement program. J Am Geriatr Soc 2002 Sep;50(9):1519-24

OBJECTIVES: We previously found in an efficacy trial that a health promotion program prevented functional decline and reduced hospitalizations in community-dwelling older people with chronic conditions. We sought to evaluate the effectiveness of the program in its dissemination phase. DESIGN: Outcome evaluation using a within-group, pretest-posttest design. SETTING: Fourteen senior centers located throughout western Washington. PARTICIPANTS: Three hundred four community-dwelling men and women aged 65 and older. INTERVENTION: A disability-prevention, chronic disease-self-management program. MEASUREMENTS: Participant characteristics, risk factors for disability, change in health and functional status, and healthcare use over 1 year of enrollment; participant satisfaction. RESULTS: Participants were 71% female, had a mean age of 76, and reported three chronic health conditions on average. The percentage of participants found to be depressed decreased (28% at time of enrollment vs 17% at 1-year follow-up, P =.005). The percentage of physically inactive participants decreased (56% vs 38%, P =.001). Physical activity level and exercise readiness improved (Physician-based Assessment and Counseling for Exercise mean score 4.3 vs 5.1, P =.001). At follow-up, 83% rated their health the same as or better than a year ago, compared with 73% at time of enrollment. The proportion with impaired functional status, as measured by bed days and restricted activity days, stayed the same. The proportion hospitalized remained stable (23% at enrollment and follow-up, P = 1.0). CONCLUSIONS: Under real world conditions, the Health Enhancement Program reaches older people at risk of functional decline. Those enrolled for 1 year experience a reduction in disability risk factors, improvement in health status, no decrements in functional status, and no increase in self-reported healthcare use.

Gurwitz JH, Rochon P. Improving the quality of medication use in elderly patients: a not-so-simple prescription. Arch Intern Med. August 12-26 2002;162:1670-1672.

Editorial-comments

Applegate WB. Elderly patients' adherence to statin therapy. JAMA. July 24-31 2002;288:495-497.

In this issue of THE JOURNAL, 2 articles present important new data that indicate persistence of use of statin therapy declines remarkably over time in 2 different elderly cohorts.^1-2 Benner and colleagues¹ used data from both New Jersey Medicaid and Pharmaceutical Assistance to the Aged and Disabled programs (1990-1999) to determine adherence with prescribed medication over a given time interval. They also evaluated persistence, defined as the duration of time over which a patient continued to fill the statin prescriptions. Filled prescription intervals were used to calculate the proportion of days covered by a statin in each quarter of a year after initiation of therapy. In the study by Jackevicius and colleagues,² several large databases from Ontario, Canada (1994-1998), were merged, including one of drug benefits, another of hospital discharge summaries, and another of health insurance benefits. In this latter study, adherence was calculated simply as having a statin prescription refilled within 120 days of the index prescription. Despite different methods of defining adherence, the findings of the 2 studies are remarkably consistent and alarming given the efficiency of statins in reducing cardiovascular morbidity. In both studies, adherence to statin therapy declined more than 25% in the first 6 months after the original prescription, with further declines in adherence the longer the cohort was followed.

Karen E. Lasser, MD,MPH; Paul D. Allen, MD,MPH; Steffie J. Woolhandler, MD,MPH; David U. Himmelstein, MD; Sidney M. Wolfe, MD; David H. Bor, MD. Timing of New Black Box Warnings and Withdrawals for Prescription Medications. JAMA. May 2002;287:2215-2220

Context: Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs.

Objective: To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market.

Design and Setting: Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black box warning).

Main Outcome Measures: Frequency of and time to a new black box warning or drug withdrawal.

Results: A total of 548 new chemical entities were approved in 1975-1999; 56 (10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs (8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn from the market. In Kaplan-Meier analyses, the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20%. Eighty-one major changes to drug labeling in the Physicians' Desk Reference occurred including the addition of 1 or more black box warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years.

Conclusions: Serious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.

Cahill JA. Responsibilities of physicians and pharmacists in preventing adverse drug reactions. JAMA. Feb 2002:287(5): 568-7 (original article immediately follows)

To the Editor: In their article about the codispensing of cisapride with contraindicated drugs, Dr Jones and colleagues¹ conclude that "[p]rescriptions dispensed by the same pharmacies accounted for a far higher proportion of contraindicated medication pairs than prescriptions from the same physicians." This conclusion seems to point a very large finger at physicians and at pharmacists, implying that neither are doing their job reviewing and intervening in drug-drug interactions.

What is not made clear, except deep within the article, is the possibility that pharmacists intervened in some of these alleged oversights. In the study, 91% of the conflicting prescriptions were for an anti-infective agent (ie, clarithromycin, erythromycin, or fluconazole). Given an average 10-day or less supply for these drugs, it is possible that the pharmacist recognized the contraindication, consulted with the patient's physician, and instructed the patient to stop taking the cisapride while taking the anti-infective drug, and to resume the cisapride upon completion. Similarly, physicians may have recognized the conflict during prescribing, and simply instructed the patient and the pharmacist that the 2 drugs should not be taken coincidently. The researchers were unable to determine if an intervention occurred, and if so, the nature and outcome of such an intervention.

Jones JK, Fife D, et. al. Coprescribing and Codispensing of Cisapride and Contraindicated Drugs. JAMA. October 3 2001;286:1607-1609

Context: Cisapride, an oral prokinetic drug indicated for the symptomatic treatment of nocturnal heartburn due to gastroesophageal reflux disease, was approved by the US Food and Drug Administration in July 1993. After reports of serious cardiac arrhythmias and deaths during administration of cisapride, most involving concomitant exposure to another drug, a series of label changes and warnings were issued in February 1995, October 1995, June 1998, and June 1999. Cisapride was removed from general distribution in July 2000.

Objective: To determine the frequency of contraindicted coprescribing and codispensings, in which cisapride and a contraindicated drug were prescribed or dispensed to the same patient for overlapping periods, and the proportion of contraindicated coprescribing by the same physicians and codispensing by the same pharmacies.

Design and Setting:Retrospective study of prescription claims from a managed care organization database for all patients with cisapride prescriptions between July 1993 and December 1998.

Participants: A total of 38 757 adult and pediatric patients who had a cisapride prescription immediately preceded by at least 60 days of insurance eligibility.

Main Outcome Measure: Proportion of cisapride prescriptions or dispensing occurring during the same treatment period as a drug contraindicated at that time prescribed by the same physicians or dispensed by the same pharmacies.

Results: Of 131 485 cisapride prescriptions dispensed after the warnings began, 4414 (3.4%) overlapped with at least 1 drug contraindicated in the labeling at the time of the prescription. Of all overlapping prescription pairs, 2190 (50%) were by the same physicians, 3908 (89%) were by the same pharmacies, and 765 (17%) were dispensed on the same day.

Conclusion: Prescriptions dispensed by the same pharmacies accounted for a far higher proportion of contraindicated medication pairs than prescriptions from the same physicians. The pharmacy may be an important and underutilized intervention point to prevent contraindicated drugs from being used together.

Kaufman DW, Kelly JP, Rosenberg L, Anderson TE, Mitchell AA. Recent patterns of medication use in the ambulatory adult population of the United States: the Slone Survey. JAMA. January 16 2002;287:337-344.

CONTEXT: Data on the range of prescription and over-the-counter drug use in the United States are not available. OBJECTIVE: To provide recent population-based information on use of all medications, including prescription and over-the-counter drugs, vitamins and minerals, and herbal preparations/natural supplements in the United States. DESIGN, SETTING, AND PARTICIPANTS: Ongoing telephone survey of a random sample of the noninstitutionalized US population in the 48 continental states and the District of Columbia; data analyzed here were collected from February 1998 through December 1999. MAIN OUTCOME MEASURE: Use of medications, by type, during the preceding week, compared by demographic characteristics. RESULTS: Among 2590 participants aged at least 18 years, 81% used at least 1 medication in the preceding week; 50% took at least 1 prescription drug; and 7% took 5 or more. The highest overall prevalence of medication use was among women aged at least 65 years, of whom 12% took at least 10 medications and 23% took at least 5 prescription drugs. Herbals/supplements were taken by 14% of the population. Among prescription drug users, 16% also took an herbal/supplement; the rate of concurrent use was highest for fluoxetine users, at 22%. Reasons for drug use varied widely, with hypertension and headache mentioned most often (9% for each). Vitamins/minerals were frequently used for nonspecific reasons such as "health" (35%); herbals/supplements were also most commonly used for "health" (16%). CONCLUSIONS: In any given week, most US adults take at least 1 medication, and many take multiple agents. The substantial overlap between use of prescription medications and herbals/supplements raises concern about unintended interactions. Documentation of usage patterns can provide a basis for improving the safety of medication use.

Hanlon JT, Schmader KE, Boult C, et al. Use of inappropriate prescription drugs by older people. J Am Geriatr Soc. January 2002;50:26-34.

OBJECTIVES: To determine the prevalence and predictors of inappropriate drug prescribing defined by expert national consensus panel drug utilization review criteria for community-dwelling older people. DESIGN: Survey. SETTING: Five adjacent urban and rural counties in the Piedmont area of North Carolina. PARTICIPANTS: A stratified random sample of participants from the fourth (n = 3,234) and seventh (n = 2,508) waves of the Duke Established Populations for Epidemiological Studies of the Elderly. MEASUREMENTS: The prescribing appropriateness for digoxin, calcium channel blockers, angiotensin-converting enzyme inhibitors, histamine(2) receptor antagonists, nonsteroidal antiinflammatory drugs (NSAIDs), benzodiazepines, antipsychotics, and antidepressants as determined by explicit criteria (through Health Care Financing Administration expert consensus panel drug utilization review criteria for dosage, duplication, drug-drug interactions and duration, and U.S. and Canadian expert consensus panel criteria for drug-disease interactions). Multivariable analyses, using weighted data adjusted for sampling design, were conducted to assess the association between inappropriate prescribing and demographic, health-status, and access-to-healthcare factors cross-sectionally and longitudinally. RESULTS: We found that 21.0 of the fourth wave and 19.2 of the seventh wave participants who used one or more agents from the eight drug classes had one or more elements identified as inappropriate. The therapeutic classes with the most problems were benzodiazepines and NSAIDs. The most common problems were with drug-disease interactions and duration of use. Longitudinal multivariable analyses found that participants who were white (adjusted odds ratio (AOR) = 1.67, 95 confidence interval (CI) = 1.28-2.17), were married (AOR = 1.40, 95% CI = 1.01-1.93), had arthritis (AOR = 1.74, 95% CI = 1.27-2.38), had one or more physical function disabilities (AOR = 1.42, 95% CI = 1.02-1.96), and had inappropriate drugs prescribed at wave 4 (AOR = 6.87, 95% CI = 5.11-9.22) were more likely to have inappropriate prescribing at wave 7. CONCLUSION: These results indicate that inappropriate prescribing is common among community-dwelling older people and persists over time. Longitudinal studies in older people are needed to examine the impact of inappropriate drug prescribing on health-related outcomes.

2001

Steinman MA; Sands LP; Covinsky KE. Self-restriction of medications due to cost in seniors without prescription coverage. J Gen Intern Med 2001 Dec;16(12):793-9

OBJECTIVE: Little is known about patients who skip doses or otherwise avoid using their medications because of cost. We sought to identify which elderly patients are at highest risk of restricting their medications because of cost, and how prescription coverage modifies this risk. DESIGN AND PARTICIPANTS: Cross-sectional study from the 1995-1996 wave of the Survey of Asset and Health Dynamics Among the Oldest Old, a population-based survey of Americans age 70 years and older. MEASUREMENTS: Subjects were asked the extent of their prescription coverage, and whether they had taken less medicine than prescribed for them because of cost over the prior 2 years. We used bivariate and multivariate analyses to identify risk factors for medication restriction in subjects who lacked prescription coverage. Among these high-risk groups, we then examined the effect of prescription coverage on rates of medication restriction. MAIN RESULTS: Of 4,896 seniors who regularly used prescription medications, medication restriction because of cost was reported by 8% of subjects with no prescription coverage, 3% with partial coverage, and 2% with full coverage (P <.01 for trend). Among subjects with no prescription coverage, the strongest independent predictors of medication restriction were minority ethnicity (odds ratio [OR], 2.9 compared with white ethnicity; 95% confidence interval [95% CI], 2.0 to 4.2), annual income <$10,000 (OR, 3.8 compared with income > or =$20,000; 95% CI, 2.4 to 6.1), and out-of-pocket prescription drug costs >$100 per month (OR, 3.3 compared to costs < or =$20; 95% CI, 1.5 to 7.2). The prevalence of medication restriction in members of these 3 risk groups was 21%, 16%, and 13%, respectively. Almost half (43%) of subjects with all 3 risk factors and no prescription coverage reported restricting their use of medications. After multivariable adjustment, high-risk subjects with no coverage had 3 to 15 times higher odds of medication restriction than subjects with partial or full coverage (P <.01). CONCLUSIONS: Medication restriction is common in seniors who lack prescription coverage, particularly among certain vulnerable groups. Seniors in these high-risk groups who have prescription coverage are much less likely to restrict their use of medications

Zhan C, Sangl J, Bierman AS, et al. Potentially inappropriate medication use in the community-dwelling elderly: findings from the National 1996 Medical Expenditure Panel Survey. JAMA. Dec 12 2001;286:2823-2829.

CONTEXT: Inappropriate medication use is a major patient safety concern, especially for the elderly population. Using explicit criteria, prior studies have found that 23.5% and 17.5% of the US community-dwelling elderly population used at least 1 of 20 potentially inappropriate medications in 1987 and 1992, respectively. OBJECTIVES: To determine the prevalence of potentially inappropriate medication use in community-dwelling elderly persons in 1996, to assess trends over 10 years, categorize inappropriate medication use according to explicit criteria, and to examine risk factors for inappropriate medication use. DESIGN, SETTING, AND PARTICIPANTS: Respondents aged 65 years or older (n = 2455) to the 1996 Medical Expenditure Panel Survey, a nationally representative survey of the US noninstitutionalized population were included. A 7-member expert panel was convened to categorize inappropriate medications. MAIN OUTCOME MEASURE: Prevalence of use of 33 potentially inappropriate medications. RESULTS: In 1996, 21.3% (95% confidence interval [CI], 19.5%-23.1%) of community-dwelling elderly patients in the United States received at least 1 of 33 potentially inappropriate medications. Using the expert panel's classifications, about 2.6% of elderly patients (95% CI, 2.0%-3.2%) used at least 1 of the 11 medications that should always be avoided by elderly patients; 9.1% (95% CI, 7.9%-10.3%) used at least 1 of the 8 that would rarely be appropriate; and 13.3% (95% CI, 11.7%-14.9%) used at least 1 of the 14 medications that have some indications but are often misused. Use of some inappropriate medications declined between 1987 and 1996. Persons with poor health and more prescriptions had a significantly higher risk of inappropriate medication use. CONCLUSIONS: Overall inappropriate medication use in elderly patients remains a serious problem. Despite challenges in using explicit criteria for assessing inappropriate medications for elderly patients, such criteria can be applied to population-based surveys to identify opportunities to improve quality of care and patient safety. Enhancements of existing data sources to include dosage, duration, and indication may augment national improvement and monitoring efforts.

Avorn, J. Improving drug use in elderly patients: getting to the next level. JAMA. Dec 12 2001;286:2866-2868.

The sensation of déjà vu is always unsettling, more so if the event reexperienced is an unpleasant one. In this issue of THE JOURNAL, Zhan and colleagues¹ provide a reprise of a now-classic tale in geriatric pharmacology and remind physicians of a persistent and troublesome issue in the care of the elderly population. The authors adapted a well-known list of drugs to be avoided in elderly patients^2-4 and apply it to data describing medication use among a nationally representative sample of older Americans, collected in 1996. Their study represents an update of studies based on data from 1987⁵ and 1992.⁶ Extrapolating from their sample to the United States as a whole, Zhan et al¹ estimate that 2.6% of the US population older than 65 years took 1 or more of 11 drugs that should never be used in this age group.

McCormick D; Gurwitz JH; Goldberg RJ; Becker R; Tate JP; Elwell A; Radford MJ. Prevalence and quality of warfarin use for patients with atrial fibrillation in the long-term care setting. Arch Intern Med 2001 Nov 12;161(20):2458-63
BACKGROUND: Evidence-based clinical practice guidelines recommend the use of warfarin sodium for stroke prevention in most patients with atrial fibrillation (AF) who do not have risk factors for hemorrhagic complications, irrespective of age. METHODS: The medical records of all residents of a convenience sample of long-term care facilities in Connecticut (n = 21) were reviewed. The percentages of all patients with AF (AF patients) and ideal candidates for warfarin therapy (ie, AF patients with no risk factors for hemorrhage) who received warfarin were determined; for patients receiving warfarin, the percentage of days spent in the therapeutic range of international normalized ratio (INR) values (2.0-3.0) was also assessed. The relationship between receipt of warfarin and the presence of stroke and bleeding risk factors was assessed in multivariate models. RESULTS: Atrial fibrillation was present in 429 (17%) of the 2587 long-term care residents. Overall, 42% of AF patients were receiving warfarin. However, only 44 (53%) of 83 ideal candidates were receiving this therapy. In residents who received warfarin therapy, the therapeutic range of INR values was maintained only 51% of the time. The odds of receiving warfarin in the study sample decreased with increasing number of risk factors for bleeding and increased (nonsignificant trend) with increasing number of stroke risk factors present. CONCLUSIONS: Atrial fibrillation is very common among residents of long-term care facilities. Even among apparently ideal candidates, warfarin therapy is underused for stroke prevention in patients with AF. Prescribing decisions and monitoring related to warfarin therapy in the long-term care setting warrant improvement.

Wenger NS, Shekelle P, Davidoff F, Mulrow C. Quality indicators for assessing care of vulnerable elders. Ann Intern Med. October 16 2001;135:641-758.

No abstract available.

Knight EL, Avorn J. Quality indicators for appropriate medication use in vulnerable elders. Ann Intern Med. October 16 2001;135:703-710.

No abstract available.

Phillips J. Retrospective analysis of mortalities associated with medication errors. Am J Health Syst Pharm – Oct. 2001; 58(19): 1835-41

The types, causes, contributing factors, and patient demographics of fatal medication errors were reviewed. Case reports of medication errors from hospitals, ambulatory care settings, and patients' homes that were entered in FDA's Adverse Event Reporting System during 1993-98 were the source of information on fatal medication errors. Each report was classified using predefined criteria and a taxonomy developed by the National Coordinating Council for Medication Error Reporting and Prevention. The types, causes, contributing factors, and patient demographics were identified, and the causality of each case was assessed to prevent future fatalities. The data indicated 5,366 medication error reports. Fifty-nine reports were excluded and classified as duplicate reports or intentional overdoses. Of the remaining medication error reports, 68.2% resulted in serious patient outcomes and 9.8% were fatal. Of the 469 fatal medication error reports, 48.6% occurred in patients over 60 years. The most common types of errors resulting in patient death involved administering an improper dose (40.9%), administering the wrong drug (16%), and using the wrong route of administration (9.5%). The most common causes of errors were performance and knowledge deficits (44%) and communication errors (15.8%). Fatal medication errors accounted for approximately 10% of medication errors reported to FDA and were most frequently the result of improper dosing of the intended drug and administration of an incorrect drug. A review of case reports of medication errors from 1993 to 1998 yielded information on the most frequent causes of and contributing factors involved in fatal medication errors.

Bikowski RM; Ripsin CM; Lorraine VL. Physician-patient congruence regarding medication regimens. J Am Geriatr Soc 2001 Oct;49(10):1353-7

OBJECTIVES: To characterize the degree of disparity between physicians' perceptions of older patients' medication regimen and patients' perceptions of their regimen. DESIGN: Prospective observational. Physicians and patients were blinded at index visit; after, trained medical students made home visits, collecting information about medications that was compared with physician questionnaires. SETTING: Community family medicine residency program. PARTICIPANTS: Patients age 65 and older presenting for routine visit, taking at least four prescription medications, and seen by index physician three or more times in the past year. Physicians were family medicine faculty and second- and third-year residents. MEASUREMENTS: Fifty physician-patient pairs were analyzed. Average age was 75 (standard deviation (SD) +/-5.5); patients averaged 7.0 prescription medications (range 3-17, SD +/-2.89). Three hundred seventy-five prescription medications were identified; the most commonly prescribed were antihypertensives (134/375; 36%). RESULTS: Congruence, defined as agreement between physician and patient regarding all prescription medications, dosages, and frequency, averaged 70% for faculty (range 53-89%) and 58% for residents (range 41-81%) (P = .08). Fourteen percent (7/50) demonstrated complete congruence; 74% (37/50) had at least one medication that either the physician was unaware the patient was taking or the physician thought the patient was taking but that was not part of the patient's regimen; 12% (6/50) had dose and/or frequency discrepancies. CONCLUSIONS: This study demonstrates significant disparity in a population where it is crucial for healthcare providers and patients to be in close agreement about intended medication regimens.

Kaushal R, Barker KN, Bates D. How can information technology improve patient safety and reduce medication errors in children's health care? Arch Pediatr Adolesc Med. September 2001;155:1002-1007.

BACKGROUND: Medication errors are common, costly, and injurious to patients. OBJECTIVE: To review the role of information technology in decreasing pediatric medication errors in both inpatient and outpatient settings. DESIGN: We performed a literature review of current information technology interventions. RESULTS: Several types of information technology will likely reduce the frequency of medication errors, although insufficient data exists for many technologies, and most available data come from adult settings. Computerized physician order entry with decision support substantially decreases the frequency of serious inpatient medication errors in adults. Certain other inpatient information technologies may be beneficial even though less evidence is currently available. These include computerized medication administration records, robots, automated pharmacy systems, bar coding, "smart" intravenous devices, and computerized discharge prescriptions and instructions. In the outpatient setting, where adherence is especially important, personalized Web pages and World Wide Web-based information have substantial potential. CONCLUSIONS: Medication errors are an important problem in pediatrics. Information technology interventions have great potential for reducing the frequency of errors. The magnitude of benefits may be even greater in pediatrics than in adult medicine because of the need for weight-based dosing. Further development, application, evaluation, and dissemination of pediatric-specific information technology interventions are essential.

Overhage JM, Perkins SM, Tierney WM, McDonald CJ. Controlled trial of direct physician order entry: effects on physicians' time utilization in ambulatory primary care internal medicine practices. J Am Med Inform Assoc July-August 2001;8:361-371.

OBJECTIVE: Direct physician order entry (POE) offers many potential benefits, but evidence suggests that POE requires substantially more time than traditional paper-based ordering methods. The Medical Gopher is a well-accepted system for direct POE that has been in use for more than 15 years. The authors hypothesized that physicians using the Gopher would not spend any more time writing orders than physicians using paper-based methods. DESIGN: A randomized controlled trial of POE using the Medical Gopher system in 11 primary care internal medicine practices. MEASUREMENTS: The authors collected detailed time use data using time motion studies of the physicians and surveyed their opinions about the POE system. RESULTS: The authors found that physicians using the Gopher spent 2.2 min more per patient overall, but when duplicative and administrative tasks were taken into account, physicians were found to have spent only 0.43 min more per patient. With experience, the order entry time fell by 3.73 min per patient. The survey revealed that the physicians believed that the system improved their patient care and wanted the Gopher to continue to be available in their practices. CONCLUSIONS: Little extra time, if any, was required for physicians to use the POE system. With experience in its use, physicians may even save time while enjoying the many benefits of POE.

Honigman B, Lee J, Rothschild J, et al. Using computerized data to identify adverse drug events in outpatients. J Am Med Inform Assoc. May-June 2001;8:254-266.

OBJECTIVE: To evaluate the use of a computer program to identify adverse drug events (ADEs) in the ambulatory setting and to evaluate the relative contribution of four computer search methods for identifying ADEs, including diagnosis codes, allergy rules, computer event monitoring rules, and text searching. DESIGN: Retrospective analysis of one year of data from an electronic medical record, including records for 23,064 patients with a primary care physician, of whom 15,665 actually came for care. MEASUREMENT: Presence of an ADE; sensitivity and specificity of computer searches for ADE. RESULTS: The computer program identified 25,056 incidents, which were associated with an estimated 864 (95 percent confidence interval [CI], 750-978) ADES. Thus, the ADE rate was 5.5 (CI, 5.2-5.9) per 100 patients coming for care. Furthermore, in 79 (CI, 68-89) ADEs, the patient required hospitalization, resulting in an estimated rate of 3.4 (CI, 2.7-4.3) admissions per 1,000 patients. The sensitivity of the search methods for identifying ADEs was estimated to be 58 (CI, 18-98) percent, and the estimated specificity was 88 (CI, 87-88) percent. The positive predictive value was 7.5 (CI, 6.5-8.5) percent, and the negative predictive value was 99.2 (CI, 95.5-99.98) percent. Compared with age and gender-matched controls with no positive screen, patients with ADEs had twice as many outpatient visits and were taking nearly three times as many drugs. Antihypertensives, ACE-inhibitors, antibiotics, and diuretics were associated with 56 (CI, 47-65) percent of ADES. Among ADEs, 23 (CI, 16-32) percent were life-threatening or serious, and 38 (CI, 29-47) percent were judged preventable. CONCLUSION: Computerized search programs can detect ADEs, and free-text searches were especially useful. Adverse drug events were frequent, and admissions were not rare, although most hospitals today do not identify them. Thus, such detection programs demonstrate "value-added" for the electronic record and may be useful for directing and assessing the impact of quality improvement efforts.

Li YC, Kuo HS, Jian WS, et al. Building a generic architecture for medical information exchange among healthcare providers. Int J Med Inf May 2001;61:241-246.

Due to the inability to exchange clinical information among hospitals, continuity of care cannot be maintained and a tremendous amount of medical resource has been wasted. This paper describes an architecture that would facilitate exchange of clinical information among heterogeneous hospital information systems. It is dubbed 'Medical Information Exchange Center' or MIEC as part of a six-year Health Information Network Project hosted by the Department of Health. MIEC was designed so that it is innovative yet technically feasible today. It is convenient for authorized users yet secure enough so people can trust and has minimal impact to participated hospitals. Authorized users will be able to access information through two web-based interfaces directed to physician and non-physician users respectively. Hospitals are connected through a virtual private network to exchange patient information and users need to obtain a private key from the certificate authority in order to securely connect to MIEC. A pilot project was conducted to demonstrate the feasibility of this architecture and the problems encountered were discussed

Honigman B, Light P, Pulling RM, Bates DW. A computerized method for identifying incidents associated with adverse drug events in outpatients. Int J Med Inf. April 2001;61:21-32.

INTRODUCTION: In inpatients, computer monitors have been used to improve the detection of adverse drug events (ADEs). However, similar programs have not been available in outpatients. OBJECTIVE: To describe an approach for detecting incidents suggesting that an ADE may have occurred in outpatients by adapting methods from inpatient computer monitoring and developing terminology searches of electronic medical records. METHODS: One year of information from the outpatient electronic medical record (EMR) at one hospital and its clinics was reviewed. Altogether, 23064 patients and 88514 visits were identified. Patient demographics, medical problem lists, ICD-9 claims, patient allergies, medication history and all clinic visit notes were extracted and merged. We then searched for incidents suggesting that an ADE might be present using four methods: ICD-9 claims, new allergies, computer rules linking laboratory data to known medication exposures, and a medical terminology lexicon (M2D2). In this report, we describe how these search methods were developed to allow for ADE identification. CONCLUSION: The ability to carry out such quality-related work is an example of the benefits of the outpatient EMR that may not be apparent to those institutions considering adopting it.

Schafer SL Prescribing for seniors: it's a balancing act J Am Acad Nurse Pract 01-MAR-2001; 13(3): 108-12

PURPOSE: To present a rational approach to prescribing for seniors, balancing the need for and number of medications. DATA SOURCES: Selected evidence-based reviews and research articles and the author's own experience. CONCLUSIONS: Whenever possible, alternatives to medication therapy should be considered as the initial treatment of choice; however, medications should be prescribed when indicated and not withheld due to a patient's age. Reducing the number of medications reduces the risk for adverse drug reactions and drug-to-drug interactions. IMPLICATIONS FOR PRACTICE: Careful review of an older patient's medication list prior to initiating new therapy is necessary. Follow-up care to review the efficacy and monitor any potential side effects is crucial. Timely discontinuation of a drug when therapeutic usefulness is surpassed is equally important.

Leipzig RM - Prescribing. Keys to maximizing benefit while avoiding adverse drug effects. Geriatrics - 01-FEB-2001; 56(2): 30-4; quiz 35

When prescribing for older patients, some physicians are overly cautious, and this strategy can result in a less than optimal treatment outcome. The reluctance to treat aggressively is understandable because the geriatric population is susceptible to adverse drug reactions. The key to maximizing therapy lies in individualizing it as much as possible. There are a number of steps physicians can take to ensure that their patients are not being undertreated. These steps include regular reevaluations of dosages and plasma drug concentrations, recognition and understanding of drug side effects, and avoidance of certain agents. Close monitoring allows physicians to minimize risks, maximize benefits, and get the most out of what modern medications can do to help older patients.

Tamblyn R; Laprise R; Hanley JA; Abrahamowicz M; Scott S; Mayo N; Hurley J; Grad R; Latimer E; Perreault R; McLeod P; Huang A; Larochelle P; Mallet L Adverse events associated with prescription drug cost-sharing among poor and elderly persons. JAMA 2001 Jan 24-31;285(4):421-9

CONTEXT: Rising costs of medications and inequities in access have sparked calls for drug policy reform in the United States and Canada. Control of drug expenditures by prescription cost-sharing for elderly persons and poor persons is a contentious issue because little is known about the health impact in these subgroups. OBJECTIVES: To determine (1) the impact of introducing prescription drug cost-sharing on use of essential and less essential drugs among elderly persons and welfare recipients and (2) rates of emergency department (ED) visits and serious adverse events associated with reductions in drug use before and after policy implementation. DESIGN AND SETTING: Interrupted time-series analysis of data from 32 months before and 17 months after introduction of a prescription coinsurance and deductible cost-sharing policy in Quebec in 1996. Separate 10-month prepolicy control and postpolicy cohort studies were conducted to estimate the impact of the drug reform on adverse events. PARTICIPANTS: A random sample of 93 950 elderly persons and 55 333 adult welfare medication recipients. MAIN OUTCOME MEASURES: Mean daily number of essential and less essential drugs used per month, ED visits, and serious adverse events (hospitalization, nursing home admission, and mortality) before and after policy introduction. RESULTS: After cost-sharing was introduced, use of essential drugs decreased by 9.12% (95% confidence interval [CI], 8.7%-9.6%) in elderly persons and by 14.42% (95% CI, 13.3%-15.6%) in welfare recipients; use of less essential drugs decreased by 15.14% (95% CI, 14.4%-15.9%) and 22.39% (95% CI, 20.9%-23.9%), respectively. The rate (per 10 000 person-months) of serious adverse events associated with reductions in use of essential drugs increased from 5.8 in the prepolicy control cohort to 12.6 in the postpolicy cohort in elderly persons (a net increase of 6.8 [95% CI, 5.6-8.0]) and from 14.7 to 27.6 in welfare recipients (a net increase of 12.9 [95% CI, 10.2-15.5]). Emergency department visit rates related to reductions in the use of essential drugs also increased by 14.2 (95% CI, 8.5-19.9) per 10 000 person-months in elderly persons (prepolicy control cohort, 32.9; postpolicy cohort, 47.1) and by 54.2 (95% CI, 33.5-74.8) among welfare recipients (prepolicy control cohort, 69.6; postpolicy cohort, 123.8). These increases were primarily due to an increase in the proportion of recipients who reduced their use of essential drugs. Reductions in the use of less essential drugs were not associated with an increase in risk of adverse events or ED visits. CONCLUSIONS: In our study, increased cost-sharing for prescription drugs in elderly persons and welfare recipients was followed by reductions in use of essential drugs and a higher rate of serious adverse events and ED visits associated with these reductions.

Walton RT, Harvey E, Dovey S, Freemantle N. Computerised advice on drug dosage to improve prescribing practice. Cochrane Database Syst Rev. 2001;1:CD002894.

BACKGROUND: Maintaining therapeutic concentrations of toxic drugs is a complex task. Several computer systems have been designed to help doctors determine optimum drug dosage. Significant improvements in health could be achieved if computer advice was shown to be beneficial. OBJECTIVES: To assess whether computer support for drug dosage benefits patients and hence whether it should be more widely available. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register (June 1996), MEDLINE (1966 to June 1996), EMBASE (1980 to June 1996), hand searched the journal Therapeutic Drug Monitoring (1979 to June 1996), reference lists of articles and contacted experts in the field. SELECTION CRITERIA: Randomised trials, interrupted time series and controlled before and after studies of computerised advice on drug dosage. The participants were health professionals responsible for patient care. The outcomes were: any objectively measured change in the behaviour of the health care provider (such as changes in the dose of drug used); any change in the health of patients, resulting from computer support (such as adverse reactions to drugs). DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Fifteen trials involving 1229 patients were included. The drugs studied were theophylline, warfarin, heparin, aminoglycosides, nitroprusside, lignocaine, oxytocin, fentanyl and midazolam. Interventions usually targeted doctors although some studies attempted to influence prescribing by pharmacists and nurses. All included studies took place on acute medical conditions in hospital settings. Although all studies used reliable outcome measures, sample size was often small and only two studies reported a sample size calculation. Computer support for drug dosage gave significant benefits reducing: 1. The time to achieve therapeutic control (standardised mean difference -0.44, 95% CI -0.70 to -0.17); 2. Toxic drug levels (risk difference -0.12, 95% CI -0.24 to -0.01); 3. Adverse reactions (risk difference -0.06, 95% CI -0.12 to 0.00); 4. Length of hospital stay (standardised mean difference -0.32, 95% CI -0.60 to -0.04). There was a tendency for computer support to result in higher doses of drugs, although this did not reach statistical significance. REVIEWER'S CONCLUSIONS: This systematic review provides evidence to support the use of computer assistance in determining drug dosage. Further clinical trials are necessary to determine whether the benefits seen in specialist applications can be realised in general use.

Shu K, Boyle D, Spurr C, et al. Comparison of time spent writing orders on paper with computerized physician order entry. Medinfo 2001;10:1207-1211.

Computerized physician order entry (CPOE) has been shown to improve quality, and to reduce resource utilization, but most available data suggest that it takes longer to enter orders using CPOE. We had previously implemented a CPOE system, and elected to evaluate its impact on physician time in the new setting. To do this, we performed a prospective study using random reminder methodology. Key findings were that interns spent 9.0% of their time ordering with CPOE, compared to 2.1% before, although CPOE saved them an additional 2% of time, so that the net difference was 5% of their total time. However, this is counterbalanced by decreased time for other personnel such as nursing and pharmacy, and by the quality and efficiency changes. We conclude that while CPOE has many benefits, it represents a major process change, and organizations must factor this in when they implement it.

2000

Gurwitz JH; Field TS; Avorn J; McCormick D; Jain S; Eckler M; Benser M; Edmondson AC; Bates DW. Incidence and preventability of adverse drug events in nursing homes. Am J Med 2000 Aug 1;109(2):87-94

PURPOSE: Adverse drug events, especially those that may have been preventable, are among the most serious concerns about medication use in nursing homes. We studied the incidence and preventability of adverse drug events and potential adverse drug events in nursing homes.METHODS: We performed a cohort study of all long-term care residents of 18 community-based nursing homes in Massachusetts during a 12-month observation period. Potential drug-related incidents were detected by stimulated self-report by nursing home staff and by periodic review of the records of nursing home residents by trained nurse and pharmacist investigators. Each incident was classified by 2 independent physician-reviewers, using a structured implicit review process, by whether or not it constituted an adverse drug event or potential adverse drug event (those that may have caused harm, but did not because of chance or because they were detected), by the severity of the event (significant, serious, life-threatening, or fatal), and by whether it was preventable. Examples of significant events included nonurticarial rashes, falls without associated fracture, hemorrhage not requiring transfusion or hospitalization, and oversedation; examples of serious events included urticaria, falls with fracture, hemorrhage requiring transfusion or hospitalization, and delirium. RESULTS: During 28,839 nursing home resident-months of observation in the 18 participating nursing homes, 546 adverse drug events (1.89 per 100 resident-months) and 188 potential adverse drug events (0.65 per 100 resident-months) were identified. Of the adverse drug events, 1 was fatal, 31 (6%) were life-threatening, 206 (38%) were serious, and 308 (56%) were significant. Overall, 51% of the adverse drug events were judged to be preventable, including 171 (72%) of the 238 fatal, life-threatening, or serious events and 105 (34%) of the 308 significant events (P < 0.001). Errors resulting in preventable adverse drug events occurred most often at the stages of ordering and monitoring; errors in transcription, dispensing, and administration were less commonly identified. Psychoactive medications (antipsychotics, antidepressants, and sedatives/hypnotics) and anticoagulants were the most common medications associated with preventable adverse drug events. Neuropsychiatric events were the most common types of preventable adverse drug events. CONCLUSIONS: Adverse drug events are common and often preventable in nursing homes. More serious adverse drug events are more likely to be preventable. Prevention strategies should target the ordering and monitoring stages of pharmaceutical care.

Bedell SE; Jabbour S, et. al. Discrepancies in the Use of Medications, Their Extent and Predictors in an Outpatient Practice. Arch Intern Med. 2000;160:2129-2134

Background Misuse of medications is a major cause of morbidity and mortality. Few studies have examined the frequency of, and factors associated with, discrepancies between what doctors prescribe and what patients take in actual practice.

Patients and Methods Patients' medication bottles and their reported use of medications were compared with physicians' records of outpatients seen between November 1997 and February 1998 in a private practice affiliated with an academic medical center in Boston, Mass. Three hundred twelve patients from the practices of 5 cardiologists and 2 internists who were returning for their routine follow-up visits were included.

Main Outcome Measure The presence of discrepancies based on comparing medication bottles with medical records.

Results Discrepancies were present in 239 patients (76%). The 545 discrepancies in these patients were the result of patients taking medications that were not recorded (n = 278 [51%]); patients not taking a recorded medication (n = 158 [29%]); and differences in dosage (n = 109 [20%]). Overall, discrepancies were randomly distributed among different drugs and discrepancy types with no discernible pattern. On multivariate analysis, patient age and number of recorded medications were the 2 most significant predictors of medication discrepancy.

Conclusions Discrepancies among recorded and reported medications were common and involved all classes of medications, including cardiac and prescription drugs. Older age and polypharmacy were the most significant correlates of discrepancy. The pervasiveness of discrepancies can have significant health care implications, and action is urgently needed to address their causes. Such action would likely have a positive impact on patient care.

Hanlon JT, Fillenbaum GG, Schmader KE, Kushibhatla M, Horner RD. Inappropriate drug use among community-dwelling elderly. Pharmacotherapy. May 2000;20:575-582

This study examined inappropriate drug use defined by updated criteria among respondents in the second and third in-person waves of the Duke Established Populations for Epidemiologic Studies of the Elderly. Information about sociodemographics, health status, access to health care, and drug use was determined by in-home interviews. Drug use was coded for therapeutic class and appropriateness by applying explicit criteria. Among participants, 27% of the second and 22.5% of the third in-person wave took one or more inappropriate agents. Of these drugs, the most common therapeutic classes were central nervous system and cardiovascular. Longitudinal multivariate analyses found that persons taking several prescription drugs, those having continuity of care, those who previously took inappropriate drugs, and those with many health visits were most likely (p<0.05) to use inappropriate drugs. We conclude that inappropriate drug use is common among community-dwelling elderly.

Gandhi TK, Burstin HR, Cook EF, et al. Drug complications in outpatients. J Gen Intern Med. March 2000;15:149-154.

OBJECTIVE: Outpatient drug complications have not been well studied. We sought to assess the incidence and characteristics of outpatient drug complications, identify their clinical and nonclinical correlates, and evaluate their impact on patient satisfaction. DESIGN: Retrospective chart reviews and patient surveys. SETTING: Eleven Boston-area ambulatory clinics. PATIENTS: We randomly selected 2,248 outpatients, 20 to 75 years old. MEASUREMENTS AND MAIN RESULTS: Among 2,248 patients reporting prescription drug use, 394 (18%) reported a drug complication. In contrast, chart review revealed an adverse drug event in only 64 patients (3%). In univariate analyses, significant correlates of patient-reported drug complications were number of medical problems, number of medications, renal disease, failure to explain side effects before treatment, lower medication compliance, and primary language other than English or Spanish. In multivariate analysis, independent correlates were number of medical problems (odds ratio [OR] 1.17; 95% confidence interval [95% CI] 1.05 to 1.30), failure to explain side effects (OR 1.65; 95% CI, 1.16 to 2.35), and primary language other than English or Spanish (OR 1.40; 95% CI, 1.01 to 1.95). Patient satisfaction was lower among patients who reported drug complications (P <.0001). In addition, 48% of those reporting drug complications sought medical attention and 49% experienced worry or discomfort. On chart review, 3 (5%) of the patients with an adverse drug event required hospitalization and 8 (13%) had a documented previous reaction to the causative drug. CONCLUSIONS: Drug complications in the ambulatory setting were common, although most were not documented in the medical record. These complications increased use of the medical system and correlated with dissatisfaction with care. Our results indicate a need for better communication about potential side effects of medications, especially for patients with multiple medical problems.

1999

Cohen, JS. Ways to minimize adverse drug reactions. Individualized doses and common sense are key. Postgrad Med Sep 1999;106(3):163-8, 171-2

The great majority of adverse drug reactions are dose-related and occur in patients taking standard doses of medications. These facts suggest that for many patients, standard drug doses may be excessive. The principle of variability among individuals, which requires tailoring the dose to the patient, needs to be reasserted in clinical medicine to reduce the incidence of side effects. Physicians should obtain patients' histories of drug reactions and have at hand information on the full range of effective drug doses, including data on low doses gathered in prerelease and postrelease drug studies. Whenever possible, manufacturers should provide a range of doses and breakable tablets to facilitate flexible dosing.

Rollman BL; Gilbert T; Lowe HJ; Kapoor WN; Schulberg HC. The electronic medical record: its role in disseminating depression guidelines in primary care practice. Int J Psychiatry Med 1999;29(3):267-86

OBJECTIVE: Using the Agency for Health Care Policy and Research Depression Guideline Panel's recommendations as its focus, this article describes a step-by-step approach for disseminating a paper-based depression guideline to primary care physicians via a commercially available electronic medical record (EMR) system. METHOD: Description of the author's approach to disseminate an evidence-based depression treatment guideline to a group of primary care physicians using a commercially available EMR system and to evaluate the results. RESULTS: We review clinical considerations and practical barriers faced in this process with the expectation that our experiences can guide others attempting to disseminate psychiatric treatment guideline via EMR systems. CONCLUSIONS: The EMR offers critical efficiencies in disseminating state-of-the-art clinical practice guidelines and in directing the primary care physicians' use of them. Still, well-designed, randomized controlled trials are necessary to demonstrate their effectiveness at enhancing patient outcomes for major depression in primary care settings.

1998

Miller LG. Herbal medicinals: selected clinical considerations focusing on known or potential drug-herb interactions. Arch Intern Med 1998 Nov 9;158(20):2200-11
Herbal medicinals are being used by an increasing number of patients who typically do not advise their clinicians of concomitant use. Known or potential drug-herb interactions exist and should be screened for. If used beyond 8 weeks, Echinacea could cause hepatotoxicity and therefore should not be used with other known hepatoxic drugs, such as anabolic steroids, amiodarone, methotrexate, and ketoconazole. However, Echinacea lacks the 1,2 saturated necrine ring associated with hepatoxicity of pyrrolizidine alkaloids. Nonsteroidal anti-inflammatory drugs may negate the usefulness of feverfew in the treatment of migraine headaches. Feverfew, garlic, Ginkgo, ginger, and ginseng may alter bleeding time and should not be used concomitantly with warfarin sodium. Additionally, ginseng may cause headache, tremulousness, and manic episodes in patients treated with phenelzine sulfate. Ginseng should also not be used with estrogens or corticosteroids because of possible additive effects. Since the mechanism of action of St John wort is uncertain, concomitant use with monoamine oxidase inhibitors and selective serotonin reuptake inhibitors is ill advised. Valerian should not be used concomitantly with barbiturates because excessive sedation may occur. Kyushin, licorice, plantain, uzara root, hawthorn, and ginseng may interfere with either digoxin pharmacodynamically or with digoxin monitoring. Evening primrose oil and borage should not be used with anticonvulsants because they may lower the seizure threshold. Shankapulshpi, an Ayurvedic preparation, may decrease phenytoin levels as well as diminish drug efficacy. Kava when used with alprazolam has resulted in coma. Immunostimulants (eg, Echinacea and zinc) should not be given with immunosuppressants (eg, corticosteroids and cyclosporine). Tannic acids present in some herbs (eg, St John wort and saw palmetto) may inhibit the absorption of iron. Kelp as a source of iodine may interfere with thyroid replacement therapies. Licorice can offset the pharmacological effect of spironolactone. Numerous herbs (eg, karela and ginseng) may affect blood glucose levels and should not be used in patients with diabetes mellitus.

1997

Hanlon JT, Schmader KE, Koronkowski MJ, et al. Adverse drug events in high risk older outpatients. J Am Geriatr Soc August 1997;45:945-948.

OBJECTIVE: To describe the prevalence, types, and consequences of adverse drug events (ADEs) in older outpatients with polypharmacy. DESIGN: A cohort study. SETTING: General Medicine Clinic at the Durham Veterans Affairs Medical Center. PATIENTS: A total of 167 high risk (taking > or = 5 scheduled medications) ambulatory older veterans who participated in a year long health service intervention trial. MEASUREMENTS: Potential ADEs were identified by asking patients during closeout interviews whether, in the past year, they had experienced any side effects, unwanted reactions, or other problems from any medication. All reported medications and corresponding adverse experiences were assessed for plausibility by a research clinical pharmacist using two standard pharmacological textbooks and categorized by predictability, therapeutic class, and organ system. RESULTS: Eighty self-reported ADEs involving 72 medications taken by 58 (35%) of 167 patients were textbook confirmed. Seventy-six of 80 (95%) ADEs were classified as Type A (predictable) reactions. Cardiovascular (33.3%) and central nervous system (27.8%) medication classes were most commonly implicated. Gastrointestinal (30%) and central nervous system (28.8%) ADE symptoms were common. Sixty-three percent of patients with ADEs required physician contacts, 10% emergency room visits, and 11% hospitalization. Twenty percent of medications implicated with ADEs required dosage adjustments, and 48% of ADE-related medications were discontinued. No significant differences (P > .05) were observed when ADE reporters (n = 58) and nonreporters (n = 109) were compared. CONCLUSION: Predictable ADEs are common in high risk older outpatients, resulting in considerable medication modification and substantial healthcare utilization.

Beers MH. Explicit criteria for determining potentially inappropriate medication use in the elderly: an update. Arch Intern Med. July 28 1997;157:1531-1536.

This study updates and expands explicit criteria defining potentially inappropriate medication use by the elderly. Additional goals were to address whether adverse outcomes were likely to be clinically severe and to incorporate clinical information on diagnoses when available. These criteria are meant to serve epidemiological studies, drug utilization review systems, health care providers, and educational efforts. Consensus from a panel of 6 nationally recognized experts on the appropriate use of medication in the elderly was sought. The expert panel agreed on the validity of 28 criteria describing the potentially inappropriate use of medication by general populations of the elderly as well as 35 criteria defining potentially inappropriate medication use in older persons known to have any of 15 common medical conditions. Updated, expanded, and more generally applicable criteria are now available to help identify inappropriate use of medications in elderly populations. These criteria define medications that should generally be avoided in the ambulatory elderly, doses or frequencies of administrations that should generally not be exceeded, and medications that should be avoided in older persons known to have any of several common conditions.

1994

Willcox SM, Himmelstein DU, Woolhandler S. Inappropriate drug prescribing for the community-dwelling elderly. JAMA. July 27 1994;272:292-296.

OBJECTIVE--To examine the amount of inappropriate drug prescribing for Americans aged 65 years or older living in the community. DESIGN--Cross-sectional survey of a national probability sample of older adults. SETTING--The 1987 National Medical Expenditure Survey, a national probability sample of the US civilian noninstitutionalized population, with oversampling of some population groups, including the elderly. SUBJECTS--The 6171 people aged 65 years or older in the National Medical Expenditure Survey sample, using appropriate weighting procedures to produce national estimates. MAIN OUTCOME MEASURES--Incidence of prescribing 20 potentially inappropriate drugs, using explicit criteria previously developed by 13 United States and Canadian geriatrics experts through a modified Delphi consensus technique. Three cardiovascular drugs identified as potentially inappropriate were analyzed separately since they may be considered appropriate for some noninstitutionalized elderly patients. RESULTS--A total of 23.5% (95% confidence interval [CI], 22.4% to 24.6%) of people aged 65 years or older living in the community, or 6.64 million Americans (95% CI, 6.28 million to 7.00 million), received at least one of the 20 contraindicated drugs. While 79.6% (95% CI, 77.2% to 82.0%) of people receiving potentially inappropriate medications received only one such drug, 20.4% received two or more. The most commonly prescribed of these drugs were dipyridamole, propoxyphene, amitriptyline, chlorpropamide, diazepam, indomethacin, and chlordiazepoxide, each used by at least half a million people aged 65 years or older. Including the three controversial cardiovascular agents (propranolol, methyldopa, and reserpine) in the list of contraindicated drugs increased the incidence of probably inappropriate medication use to 32% (95% CI, 30.7% to 33.3%), or 9.04 million people (95% CI, 8.64 million to 9.44 million). CONCLUSION--Physicians prescribe potentially inappropriate medications for nearly a quarter of all older people living in the community, placing them at risk of drug adverse effects such as cognitive impairment and sedation. Although most previous strategies for improving drug prescribing for the elderly have focused on nursing homes, broader educational and regulatory initiatives are needed.

1991

Morrow D; Leirer V; Altieri P; Tanke E. Elders' schema for taking medication: implications for instruction design. J Gerontol 1991 Nov;46(6):P378-85

We examined whether elders share a schema for taking medication and if instructions are better understood and recalled when organized to match this pre-existing schema. Experiment 1 investigated if elders agree on how to group medication information into categories, and if they agree on an order for arranging this information. Elders tended to organize information into three categories, arranged in the following order: General information about the medication (purpose), How to take (dose and schedule), and Outcomes (emergency information). In Experiment 2, we compared instructions that were: (a) compatible with this schema in terms of grouping and order, (b) compatible only in terms of grouping (category order was changed), and (c) incompatible, not matching the model in terms of either grouping or order. Memory for medication information increased with the compatibility of the instructions to the model. Elders also preferred the more compatible instructions. The findings suggest that elders possess a schema for taking medication, which they use to understand and recall medication instructions.

Gurwitz JH; Avorn J. The ambiguous relation between aging and adverse drug reactions. Ann Intern Med Jun 1991;114(11):956-66

PURPOSE: To examine the evidence for a relation between advancing patient age and the risk for adverse drug reactions. DATA SOURCE: A computer-assisted search of the English-language literature (MEDLINE, 1966 to 1990) followed by selective review of all pertinent articles. STUDY SELECTION: Studies that stratified data on adverse drug reactions by patient age were screened for review. Article selection was not limited by study design; the relation between age and the occurrence of adverse drug reactions did not have to be a primary focus of the study. DATA EXTRACTION: Pertinent data were abstracted from the results of case-control and cohort studies and from clinical trials. The methodologic strengths and weaknesses of these studies are discussed with particular reference to gerontologic issues. RESULTS OF DATA SYNTHESIS: Most studies have neglected the issue of whether the increased frequency of adverse drug reactions in the elderly is attributable to age alone or to the fact that older patients are more likely to have coexisting illnesses and to be taking several medications. Studies that combine all drug exposures for each patient and report the risk for any adverse effect provide little useful information about the risks associated with specific drug therapies in the elderly. The association between age and the risk for adverse drug reactions is best examined for individual pharmacologic agents. However, the exclusion of elderly subjects from clinical trials makes the determination of age effects impossible in many studies. Where subjects do represent an adequate age range, most studies fail to control for important clinical differences among subjects of different ages to distinguish the independent effects of chronologic age. CONCLUSION: Conventional clinical wisdom suggests that the risk for adverse drug reactions increases with advancing age, but available data do not confirm this "truism" of geriatric medicine. The inter-individual variability of the aging process, including the non-uniform nature of the pharmacokinetic and pharmacodynamic changes that occur with aging, indicates that clinical reality is far more complex. Patient-specific physiologic and functional characteristics are probably more important than any chronologic measure in predicting both adverse and beneficial outcomes associated with specific drug therapies.

1990

Col N, Fanale JE, Kronholm P. The role of medication noncompliance and adverse drug reactions in hospitalizations of the elderly. Arch Intern Med. April 1990;150:841-845.

We interviewed 315 consecutive elderly patients admitted to an acute care hospital to determine the percentage of elderly hospital admissions due to noncompliance with medication regimens or adverse drug reactions, their causes, consequences, and predictors. Eighty-nine of the elderly admissions (28.2%) were drug related, 36 due to noncompliance (11.4%), and 53 due to adverse drug reactions (16.8%). One hundred three patients had a history of noncompliance (32.7%). Factors statistically associated with a higher risk of hospitalization due to noncompliance were poor recall of medication regimen, seeing numerous physicians, female, medium income category, use of numerous medications, and having the opinion that medications are expensive. Factors associated with an increased risk of an admission due to an adverse drug reaction were use of numerous different medications, higher medication costs, receiving Medicaid, and not receiving any home services. In conclusion, many elderly admissions are drug related; noncompliance accounting for a substantial fraction of these. Elders at high risk of being noncompliant are identifiable using a variety of criteria. Economic factors were important in predicting admissions due to noncompliance as well as adverse drug reactions.

1986

Murray MD; Darnell J; Weinberger M; Martz BL. Factors contributing to medication noncompliance in elderly public housing tenants. Drug Intell Clin Pharm 1986 Feb;20(2):146-52

A study examined the extent and correlates of noncompliance in 155 predominantly elderly public housing tenants. Data were gathered through in-home interviews; only data from tenants taking prescribed medications on a regularly scheduled basis (n = 140) were analyzed. Noncompliance was significantly (p less than 0.05) associated with taking more than five prescribed medications, an inability to read prescription and auxiliary labels, and difficulty opening flip-off type medication container lids. The results indicate that attempts to reduce the total number of prescription drug products used in these elderly residents by carefully scrutinizing the need for each prescription drug may enhance compliance. Pharmacists could assist in the detection of elderly patients at risk for medication noncompliance (five or more total prescription medications) by assessing the patients' ability to read labels on prescription containers for all new drug additions and refills, and by having them try to open a flip-off container lid.

Darnell JC; Murray MD; Martz BL; Weinberger M. Medication use by ambulatory elderly. An in-home survey. J Am Geriatr Soc 1986 Jan;34(1):1-4

The elderly residents of an urban subsidized apartment building were interviewed in their apartments to determine a comprehensive medication profile. The interviews were conducted by doctor of pharmacy candidates, and 155 residents (81.2%) participated. Compliance was similar to rates previously reported (49.3%), and adverse drug reactions were common (29.1%). Other findings included: compliance did not decrease with advancing age; most elderly individuals could open child-resistant containers (83.4%), read standard container labels (79.7%), and identify teaspoon (97.3%) and tablespoon (88.5%) quantities; inability to open easy-open (flip-off) containers decreased compliance (P = .03); men were more compliant than women (68.4 v 42.4%, P = .006) but were taking fewer medications (3.3 per male v 5.0 per female); only 12.6% of respondents thought they were taking too much medication but when they did compliance diminished (P = .003); medications were infrequently shared (5.6% of respondents reported sharing); and only 6.4% of respondents reported medication expense as a concern.

Hutchinson TA, Flegel KM, Kramer MS, Leduc DG, Kong HH. Frequency, severity and risk factors for adverse drug reactions in adult out-patients: a prospective study. J Chronic Dis 1986;39:533

To provide information on the frequency of adverse drug reactions in ambulatory patients we used intensive telephone surveillance to detect suspected reactions in 1026 patients seen at an internal medicine group practice over a 1-year period. Two hundred and ninety-two suspected reactions were detected. The majority of suspected reactions were mild, causing predominantly worry or discomfort. We used a published algorithm to assess the suspected reactions for drug causation with the following results: 40 (14%) unlikely; 193 (66%) possible; 56 (19%) probable; and 3 (1%) definite. The rate of probable or definite reactions was 49/1026 (5%) per patient and 58/3330 (2%) per drug course. Surprisingly, neither the age of the patient nor the number of other drugs he was taking modified the risk of a reaction to an individual newly-started drug. Our data suggest that fear of adverse reaction should not usually be a major factor in therapeutic decision making for an ambulatory patient even when the patient is old or already on multiple drugs.