Charles D. Hepler

Preventable Drug-Related Hospital Admissions

OBJECTIVE: To estimate the prevalence of preventable drug-related hospital admissions (PDRAs) and to explore if selected study characteristics affect prevalence estimates. METHODS: Keyword search of MEDLINE (1966–December 1999), International Pharmaceutical Abstracts (1970–December 1999), and hand search. Two reviewers independently selected studies published in peer-reviewed journals and extracted crude prevalence estimates and study characteristics. Trials had to specifically address consequences of drug therapy requiring hospital admission and include a quantitative preventability assessment. Stratified analysis and meta-regression were used to explore the association between study characteristics and prevalence estimates. DATA SYNTHESIS: Fifteen studies reported a median PDRA prevalence of 4.3% (interquartile range [IQR] 3.1–9.5%). The median preventability rate of drug-related admissions was 59% (IQR 50–73%). No evidence of publication bias related to study size could be determined. Because the individual study results were highly heterogeneous (Cochrans Q = 176, df = 14; p < 0.001), no meta-analytic summary estimate was computed. Stratified analysis suggested an association between prevalence estimates and 3 study characteristics: exclusion of first admissions (readmission studies: average PDRA prevalence of 14.0 %, estimated prevalence OR = 3.7); mean age of admissions >70 (OR = 2.1); and inclusion of “indirect” drug-related morbidity, such as omission errors or therapeutic failure (OR = 1.9). There was little evidence of other associations with prevalence estimates, such as selection of specific hospital units, exclusion/inclusion of planned admissions, country, and specified methods of PDRA case ascertainment. CONCLUSIONS: Drug-related morbidity is a significant healthcare problem, and a great proportion is preventable. Study methods in prevalence reports vary and should be considered when interpreting findings or planning future research.

Clinical pharmacy, pharmaceutical care, and the quality of drug therapy.

Background. Because of concerns about patient safety and the quality of health care in America, in particular about drug therapy, pharmacists have unprecedented opportunities to increase their value and significance. When defining clinical pharmacy and pharmaceutical care, pharmacists long ago recognized the need to improve the safety and effectiveness of drug therapy.

Research: Improving Drug Therapy for Patients with Asthma-Part 1: Patient Outcomes

OBJECTIVE To evaluate the effects of a therapeutic outcomes monitoring (TOM) program on selected process and outcome measures. DESIGN Prospective, controlled, multicenter study. SETTING Community pharmacies throughout Denmark (16 intervention, 15 control). PATIENTS Five hundred patients with asthma aged 16 to 60 years and treated in primary care. INTERVENTION TOM is a community-based program for pharmaceutical care. Using a structured, seven-step, cyclical outcome improvement process, TOM pharmacists identify and resolve (or refer) problems with drug therapy that, if not addressed, might result in therapeutic failure or adverse effects. Equal emphasis is placed on the patients perspective (e.g., coping, control, and empowerment) and the professionals perspective (e.g., adherence, patient knowledge, and therapeutic problems). TOM requires cooperation among pharmacists, patients, and physicians. MAIN OUTCOME MEASURES Asthma symptom status, days of sickness, health-related and asthma-specific quality of life, use of health care services and resources, and satisfaction with health care and pharmacy. INTERMEDIATE OUTCOME AND PROCESS MEASURES: Peak expiratory flow rate (PEFR), knowledge of asthma and asthma medications, inhalation errors, and drug therapy problems in the TOM group. RESULTS The mean individual differences for TOM and control patients were tested. Beneficial effects were found for the following outcome measures: asthma symptom status, days of sickness, and health-related and asthma-related quality of life. Satisfaction with health care and pharmacy varied throughout the course of the project, with no significant difference between groups at the final evaluation. Although not statistically significant, differences in use of services were considered to be clinically significant and encouraging. Beneficial effects were found for knowledge of asthma and medications, inhalation errors, drug use and drug therapy problems. No significant differences were found for PEFR. CONCLUSION The project demonstrated that therapeutic outcomes monitoring by community pharmacists is an effective strategy for improving the quality of drug therapy for asthma patients in primary health care.

Pharmaceutical care versus traditional drug treatment. Is there a difference

The purpose of drug therapy should be to improve the length and quality of peoples lives. Availability of safe and effective drug products has improved the management of both acute and chronic diseases toward those objectives. Drug therapy is, perhaps, the most frequent mode of therapy for most illnesses. About two-thirds of office visits to US physicians result in new or renewed prescriptions,lI,2] Drugs also may be the most heavily studied therapeutic modality. Perhaps because of drug marketing laws in developed nations, drug therapy has a strong scientific basis. Despite extensive scientific knowledge, however, an expanding literature shows that we often fail to control the risks of drug therapy. There is reason to believe that eventually the most important difference between traditional drug treatment and pharmaceutical care may be that pharmaceutical care improves patient outcomes and reduces total costs of care. The idea of pharmaceutical care is, in part, a response to the failures of traditional drug treatment, but is more importantly an approach to improving peoples length and quality of life. It is primarily an idea about how health professionals and patients should integrate their work to obtain the outcomes important to patients and clinicians. It is simultaneously an idea about how pharmacists should practice clinically in cooperation with patients and other professionals,l3-6] 1. Adverse Outcomes of Drug Therapy

Regulating for Outcomes as a Systems Response to the Problem of Drug-Related Morbidity

OBJECTIVE To describe the evidence that preventable adverse outcomes of drug therapy are prevalent in the United States and Europe, to describe the causes of this problem, to outline a systems response that would correct or improve the problem, to discuss pharmacys contribution to that solution, and to propose a strategy for implementation. SUMMARY The causes of the widespread problem of preventable drug-related morbidity (PDRM) that have been identified in the literature constitute system failure. Health professionals can understand an individual patients care system if they organize their thinking about systems as efficiently as they organize their thinking about medical or pharmaceutical problems. Six essential system characteristics are proposed, based on the PDRM literature. Regulations should mandate regular patient and system performance assessments--specifically, that health professionals (1) identify, resolve, and document specific pharmacotherapy problems; (2) assess system performance and identify recurring root causes of problems; and (3) document assessments, problems found, actions taken, and follow-up. These regulations would, in essence, mandate individual quality improvement (QI) programs. QI and pharmaceutical care require similar processes of decisions and actions, one from a practice (multipatient) perspective and the other from a patient perspective. CONCLUSION Health care accreditation agencies are moving toward regulation for outcomes. Pharmacy managers should embrace and regulatory boards should participate in this movement. Such regulations would clarify pharmacys role in support of safe and effective pharmacotherapy and would constitute a commitment to pharmaceutical care as public service. A widely adopted system of measuring and improving the quality of medication use and outcomes could eventually lead to quality benchmarks in the community pharmacy setting, which would more firmly establish the value of the pharmacist in pharmacotherapy.

Clinical Trial of Topical Erythromycin in Inflammatory Acne

Sixty-nine informed subjects participated in a split-face, double-blind trial of topical erythromycin base 2% in Vehicle/N® versus Vehicle/N® alone. All subjects had grades II or III acne as described by Pillsbury. Study solutions were assigned to a randomly selected side of the subjects face. Solutions were applied twice daily. Inflammatory lesion counts were performed by the same investigator during the eight weeks of study at biweekly intervals. The difference in inflammatory lesion counts from beginning to end of study for each side of the face was compared utilizing Students paired t-test There was not a statistically significant difference in mean inflammatory lesions at the end of eight weeks (D̅ = 1.46, t = 1.36, df 68). There was, however, a significant difference at two and six weeks (D̅ = 2.59, t = 3.72, df 68; D̅ = 1.41, t = 2.03, df 68). Observed differences in lesion counts were not considered to be clinically significant.

Application of system-level root cause analysis for drug quality and safety problems: a case study.

BACKGROUND Automated surveillance indicators are used to identify problems with drug therapy. A previous study automated 39 indicators of possible drug-related emergency department visits and hospitalizations. These indicators were used to investigate the quality and safety of drug use in a large health care coalition in Florida. This study describes a method of capturing this input with an aim of applying it to a root cause analysis (RCA), which may be useful for improving system-level flaws and weaknesses in medication use. OBJECTIVE To apply results of a computerized surveillance system containing selected indicators of potential drug-related emergency department and hospital admissions to an RCA for evaluation. Such evaluation might prove effective in determining criteria useful in improving the quality and safety of systemic responses to individual types of drug therapy problems. METHODS This was a case study that brought together a study group of 6 coalition stakeholders to evaluate findings from 4 indicators. The indicators represented problems in the prescribing, adherence, and monitoring steps in the ambulatory care medication use system. The RCA included the following procedures: brainstorming of possible system failures, organizing proposed system failures into groups and corresponding system levels, voting to prioritize proposed system failures, tree diagramming to illustrate how the system failures are interconnected among system levels, and determining whether system conditions or failure sequences are common among indicator types. RESULTS The group judged 3 themes to be important contributors to drug-related problems identified by the 4 indicators, including lack of patient knowledge, patient nonadherence to medical recommendations, and lack of medication management systems. The group believed that these barriers were interconnected and the result of subsystem influences. CONCLUSION Drug therapy problems represented by the indicators have certain system failures, flaws, or defects in common, allowing them to occur and persist. RCA may be a useful method for evaluating population-level indicator findings to identify potential failures with the medication use system and develop interventions.