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Assessing the appropriateness of physician prescribing for geriatric outpatients. Development and testing of an instrument.

OBJECTIVE: In a randomized, controlled trial evaluating the impact of clinical pharmacists' consultations on physicians' prescribing decisions, a seven-member physician/pharmacist panel developed an instrument to characterize and quantify the full range of drug-prescribing problems. The instrument was tested for validity and reliability. SAMPLE: The instrument was applied in reviewing prescribing for 236 geriatric outpatients. METHODS: To ensure internal validity of the instrument, five panel meetings were devoted to reaching a consensus on procedures, categories, criteria, and scoring. Each case was evaluated independently by two reviewers and each drug in the regimen was evaluated for drug-drug interactions, dosage, schedule, allergic reactions, therapeutic duplication, use of drugs without established diagnoses, and inappropriate drugs for the patient's clinical conditions; discrepancies were adjudicated by the panel chairperson. Self-reported adverse effects of 60 study patients who were interviewed, and hospital readmissions of all study patients were used to test the external validity of the instrument. RESULTS: Inter-rater reliability improved over time, reaching a high of 97.1 percent after six months. A positive association was determined between the prescribing scores and the number of reported adverse effects (rho = 0.28, p = 0.02). Although the number of patients with drug-related hospital readmissions was too few to establish a significant association between the prescribing scores and readmissions, the findings were expected. CONCLUSIONS: Given current requirements for drug utilization reviews in hospitals, health maintenance organizations, and Medicaid programs, this instrument may prove to be very useful.

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Impact of inappropriate drug use among hospitalized older adults.

OBJECTIVE: Criteria for inappropriate drug use developed by Beers have been widely used in drug utilization reviews as the basis for educational materials and to assess the quality of prescribing. However, there is inconclusive evidence that these criteria can impact on patient outcomes. The objective of this study was to evaluate the impact of inappropriate drug use on all-cause mortality, adverse drug reactions (ADRs) and length of stay among in-hospital patients. METHODS: We performed a retrospective, cohort study on 5,152 patients aged 65 years or older admitted to 81 hospitals in Italy between 1997 and 1998. Inappropriate drug use was defined by 2003 Beers criteria. Outcomes of the study were: (a) in-hospital mortality; (b) incidence of ADR occurring during hospital stay; (c) length of hospital stay 13 days or more. RESULTS: The mean age of 5,152 participants was 78.8 years (standard deviation = 8.4 years), and 2,463 (47.8%) were men. During hospital stay, 1,475 (28.6% of the study sample) patients received one or more inappropriate drugs. After adjusting for potential confounders, use of inappropriate drugs was not associated significantly with either mortality [odds ratio (OR) 1.05; 95% confidence intervals (CI): 0.75-1.48], ADR (OR 1.20; 95% CI: 0.89-1.61) or length of stay 13 days or more (OR 1.09; 95% CI: 0.95-1.25). CONCLUSIONS: This study did not show any significant effect of inappropriate drug use defined by Beers 2003 criteria on health outcomes among hospitalized older adults. Further studies conducted in different settings, using additional health outcomes and alternate measures of inappropriate drug use, are needed.

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Plasma protein fraction and albumin use: the effect of medical staff education.

A 6-week audit evaluating the use of plasma protein fraction and albumin was conducted and study data demonstrated that these colloids were being inappropriately prescribed. The P & T Committee decided to use educational rather than restrictive methods to improve colloid prescribing. Follow-up audits were performed, one immediately following staff education and another 1 year after the first audit. Although the educational actions employed in this drug utilization review appeared to have an immediate impact, the effect was not sustained long-term, indicating the need for periodic medical staff education. Methods of effective educational intervention as reported in the literature are discussed.

Colloids↗

Serotonin reuptake inhibitors and the adequacy of antidepressant treatment.

OBJECTIVE: To determine whether the use of serotonin reuptake inhibitors (SSRIs) improves antidepressant medication prescribing patterns for both psychiatric and non-psychiatric physicians. DATA SOURCES/SETTING: Drug utilization review of 4,103 prescriptions for antidepressant medications with patients diagnosed with depressive disorders over an eighteen-month period from the formulary records of a large insurance company. DESIGN: Using standards developed for clinical guidelines, variation in trial and treatment adequacy between drug types and physician specialty was studied. PRINCIPAL FINDINGS: Thirty-five percent of initial antidepressant trials were not prescribed for an adequate duration or at an adequate dosage level. SSRIs were more likely to be prescribed adequately than any other antidepressant reviewed. Psychiatrists were more likely to prescribe antidepressants at an adequate dosage level, whereas non-psychiatric physicians were more likely to attain adequate duration of treatment. CONCLUSIONS: A greater reliance on SSRIs may increase the likelihood of maintaining adequacy in antidepressant treatments. Although higher in cost than other treatment choices, their lower side effect profile is likely to maximize patient satisfaction and physician and patient adherence to guidelines. In order to ensure effective and efficient antidepressant usage, such patterns must be identified and appropriate performance improvement strategies (e.g., Total Quality Improvement, critical pathways) may be employed.

Antidepressive Agents↗

Managing prescription drug costs.

This article reviews prescription drug cost trends, touching on issues such as cost versus value, demographic changes, direct-to-consumer advertising, effects of the Internet and disease management. The author also discusses pharmacy benefit managers, as well as various utilization management strategies like benefit plan design and the use of formularies.

Cost Control↗

How pharmacists respond to on-line, real-time DUR alerts.

OBJECTIVE: To quantify the type and frequency of drug utilization review (DUR) alerts sent by one claims processor to pharmacists; identify how pharmacists respond to these on-line, real-time DUR messages; and quantify the interventions taken by these pharmacists as a result of these alerts. DESIGN: Retrospective analysis of Medicaid claims from July 1, 1995, through June 30, 1996. SETTING: State of Delaware. PARTICIPANTS: 55,000 Medicaid recipients served by 170 participating pharmacies and 2,000 physicians. INTERVENTIONS: All on-line DUR alerts sent to pharmacists and the pharmacists' responses were categorized by alert type and analyzed by drug class. MAIN OUTCOME MEASURES: Pharmacists' response (dispensed prescription, contacted prescriber, talked with patient, consulted own reference sources) and drug classes. RESULTS: During the study period, 807,017 claims generated 83,260 DUR alerts involving 73,554 (9.1%) prescriptions. Prescriptions were not dispensed in 20.9% of cases because of the DUR message. Prescriptions were dispensed 17.7% of the time after the pharmacist contacted the prescriber, in 20.6% of cases after the pharmacist talked with the patient, and 37.2% of the time after reviewing internal resources. Action taken by pharmacists varied among and within DUR criteria categories. Specific examples of alerts generated in high-frequency and high-profile areas are reviewed, some of which generated inconsistent responses. CONCLUSION: Among Delaware Medicaid providers, drug alerts resulted in pharmacists not dispensing prescriptions in a surprising percentage of situations. Pharmacists' responses varied according to the drug class involved and the type of alert received.

Drug Interactions↗

Prescribing practices of outpatient child psychiatrists.

OBJECTIVE: This study was designed to assess outpatient child psychiatrists' prescribing practices. METHOD: Of 1,422 outpatients in two public, university affiliated settings in New York and Ohio, the charts of 146 medicated and 126 nonmedicated randomly selected patients were reviewed for demographic variables, DSM-III-R diagnoses, medications prescribed, and charted prescription rationales. RESULTS: Fifteen percent of the 800 outpatients seen in a 1-month period in New York, and 19% of the 626 outpatients seen in a 1-year period in Ohio were prescribed medication. Patients medicated by clinic psychiatrists were significantly more likely than nonmedicated patients to be psychotic and to have been hospitalized previously, and significantly less likely to have adjustment disorder. Using standards employed by drug utilization review committees, medications were prescribed appropriately in approximately 90% of cases. Of concern, 65% of patients given antipsychotics in New York and 67% in Ohio were not psychotic; the primary target symptom in such cases was aggression. CONCLUSIONS: Prescribing practices appeared to be appropriate, although the use of antipsychotic medications in nonpsychotic children is a concern for the field of child psychiatry. The strong similarity of practices in two independent and geographically remote sites suggests the findings are generalizable to providers in other public, university affiliated settings.

Adolescent↗

Clinical pharmacists' impact on prescribing in an acute adult psychiatric facility.

An analysis is presented of data collected to evaluate the impact of a clinical pharmacy service on an acute psychiatric admitting unit. Retrospective longitudinal drug utilization reviews (RLDUR) were performed one year apart (pre- and post-implementation of services) on the same treatment team. Process measures significantly affected include (percent reduction): total drugs/patient (33.9), number of antipsychotic drugs/patient (38.0), number of anticholinergics started on admission/patient (53.2), and number of doses/patient/d (42.4). Other drug-use parameters significantly affected include: a 42-percent increase in the mean dosage expressed as chlorpromazine equivalents, and a 47-percent reduction in the number of patients on low potency antipsychotic medications. Beneficial outcome was reflected by a faster rate of discharge or transfer to a less restrictive ward environment in the pharmacy study population. The study population also demonstrated a 55.8-percent decrease in their readmission rate to the facility over a one-year follow-up period. Clinical pharmacy services positively affect both process and outcome health care measures.

Acute Disease↗

Impact of an aminoglycoside kinetic service on aminoglycoside use in a community hospital.

The effectiveness of an aminoglycoside monitoring service in improving the prescribing patterns of physicians in the hospital was evaluated. A drug utilization review (DUR) done as part of routine monitoring demonstrated a deficiency in eight of 19 elements based on national DUR standards. An aminoglycoside monitoring program developed by the Pharmacy Department was then implemented. A comparative DUR demonstrated significant improvement in five previously deficient elements, a trend towards improvement in two elements, and no change in one element. We conclude that a concurrent drug monitoring program with aggressive pharmacy participation improves prescribing patterns by physicians.

Aminoglycosides↗

Validation of diagnostic codes within medical services claims.

OBJECTIVES: Few studies have attempted to validate the diagnostic information contained within medical service claims data, and only a small proportion of these have attempted to do so using the medical chart as a gold standard. The goal of this study is to determine the sensitivity and specificity of medical services claims diagnoses for surveillance of 14 drug disease contraindications used in drug utilization review, the Charlson comorbidity index and the Johns Hopkins Adjusted Care Group Case-Mix profile (ADGs). STUDY DESIGN AND SETTING: Diagnoses were abstracted from the medical charts of 14,980 patients, and were used as the "gold standard," against which diagnoses obtained from the administrative database for the same patients were compared. RESULTS: Conditions associated with drug disease contraindications with the exception of hypertension and chronic obstructive pulmonary disease (COPD) showed a specificity of 90% or higher. Sensitivity of claims data was substantially lower, with glaucoma, hypertension, and diabetes being the most sensitive conditions at 76, 69, and 64%, respectively. Each of the 18 disease conditions contained in the Charlson comorbidity index showed high specificity, but sensitivity was more variable among conditions as well as by coding definitions. Although ADG specificity was also high, the vast majority of ADGs had sensitivities of less than 60%. CONCLUSION: The administrative data was found to have diagnoses and conditions that were highly specific but that vary greatly by condition in terms of sensitivity. To appropriately obtain diagnostic profiles, it is recommended that data pertaining to all physician billings be used.

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[Research on antiemetics: an Italian model of success].

At the beginning of the 80's the Italian Group for Clinical Research (G.O.I.R.C.) identified chemotherapy-induced nausea and vomiting as one of the most distressing adverse events, and decided to plan and execute clinical trials on antiemetics in order to reduce this negative impact on patients. Therefore, some consecutive double-blind randomized trials were conducted on cisplatin-treated patients. The first was a dose-finding study on four different high-doses of domperidone, followed by a study comparing two different high-doses of metoclopramide, and a study comparing the addition of a corticosteroid to high-dose metoclopramide with respect to metoclopramide alone. Finally, a study demonstrating that a combination of a higher dose of metoclopramide (3 mg/kg x 2) plus dexamethasone and diphenhydramine was significantly superior with respect to a lower dose of metoclopramide (1 mg/kg x 4) combined with methylprednisolone was carried out. With the introduction of the 5-HT3 receptor antagonists the interest for antiemetic therapy increased and other Italian gynecological and medical oncology centres became involved in the antiemetic research. The Italian Group for Antiemetic Research was formed in 90's and its first study demonstrated the superiority of a combination of a 5-HT3 receptor antagonist plus dexamethasone with respect to the standard three drug combination of high doses of metoclopramide in the prevention of cisplatin-induced acute emesis. In the following years, the Group contributed to the identification of the best antiemetic prophylaxis for acute emesis induced by moderately emetogenic chemotherapy, and for delayed emesis induced by cisplatin. Also a drug utilization review on antiemetics in clinical practice has recently been carried out. Today, the interest of the Group is concentrated in studying the optimal antiemetic prophylaxis for delayed emesis induced by moderately emetogenic chemotherapy. The rules always followed by the Italian Group for Antiemetic Research are: --complete independence of judgement on the efficacy and the tolerability of antiemetic drugs from the pharmaceutical companies; --priority of ethical problems in designing clinical trials; --strict adherence to the methodological problems of antiemetic research and--complete autonomy concerning the study planned, the data computerization and the data elaboration. In the last twelve years approximately 70 Italian centres have enrolled their patients into the studies of the Italian Group for Antiemetic Research.

Antiemetics↗

Pharmacotherapy quality improvement in the managed care setting.

Physician partnering, value-added relationships, and integrated delivery systems with risk/incentive arrangements are emerging in managed care. These arrangements require time-sensitive program information that can be used in continuous quality improvement programs. Components of any clinical intervention program designed to improve the quality of pharmacotherapy are on a continuum, from those that are primarily individual patient focused to those that are disease or system/process focused. Components include case management, patient profile review, brand to generic drug conversion, targeted therapeutic evaluations, provider profiling, and pharmacoeconomic analysis. All health care professionals involved in pharmacotherapy need to be involved in implementation of these quality improvement programs.

Cost Control↗

Changing prescribing patterns: a program of physician education.

A drug utilization review identified significant inappropriate use of second-generation cephalosporins at a 700-bed community teaching hospital. As a result, an educational program designed to modify physician prescribing patterns was developed as a cost-containment measure. Educational guidelines listing indications and contraindications for cefamandole and cefoxitin and comparing their costs with those of first-generation cephalosporins were placed in patient records, and physician use of these agents was reviewed before, during, and after the intervention. The rate of combined appropriate use of cefamandole and cefoxitin increased from 30 to 58% during the study. A change from the second-generation cephalosporins to therapeutically equivalent, less-expensive drugs was noted in 28% of patients' medical records within 48 hours after placement of the guidelines. This educational program proved to be a low-cost method of successfully altering the prescribing patterns of physicians.

Cephalosporins↗

Evaluation of amitriptyline use for depression when prescribed by internists and psychiatrists.

The efforts involved in structuring and implementing a drug utilization review (DUR) program that was designed to assess the use of amitriptyline for depression when prescribed by internists and psychiatrists is described. In-depth audit criteria were used to identify deviations from the criteria for each group. An immediate goal of this amitriptyline DUR program is to apply the results of the study toward the implementation of a targeted, multifaceted educational program. The design of the DUR program should emphasize the individual needs of each of the two study groups.

Amitriptyline↗

Pharmacy benefit management: enhancing the applicability of pharmacoeconomics for optimal decision making.

Previous research indicates that in order to make pharmacoeconomic information applicable and useful for pharmaceutical benefit management (PBM) companies, several aspects need to be considered and improved. These include: timely availability of information, head-to-head comparators, peer-reviewed publications, independent sponsorship of pharmacoeconomic studies, use of relevant populations in research and published pharmacoeconomic models, and pharmacoeconomics training for pharmaceutical companies' sales personnel. In addition to these measures, guidelines have been playing an important role in improving the applicability of pharmacoeconomic information. This paper examines the progress to date in enhancing the applicability of pharmacoeconomics for optimal PBM decision making. The greatest improvements have been made in enhancing the quality of pharmacoeconomic research and the quality of peer-reviewed publications. Direct comparator studies are starting to emerge, but in limited numbers. The need for additional training of pharmaceutical representatives and PBM staff members remains a critical issue.

Cost-Benefit Analysis↗

A model for improving medication use in home health care patients.

OBJECTIVES: (1) To develop a model for the identification and resolution of problems associated with suboptimal medication use in elderly patients receiving home health care; (2) To select the most important identifiable problems and develop structured procedures for their resolution. DESIGN: Expert panel review, problem selection, and development of a problem resolution model and guidelines. SETTING: Home health care. PARTICIPANTS: A panel with expertise in home health nursing, pharmacy, clinical pharmacology, gerontology, pharmacoepidemiology, and health services research. INTERVENTIONS: A list of potential problems associated with the most frequently used classes of drugs was compiled for review by the panel. Problems that were controversial or that could not be identified in the home care setting were excluded. Panel members individually ranked the remainder. Detailed procedures for identification and resolution of the 15 top-ranking problems were developed. MAIN OUTCOME MEASURES: Not applicable. RESULTS: Potential medication problems were defined by both drug use and symptoms or clinical signs associated with specific adverse effects, to ensure that clinically relevant problems would be identified. The model developed for problem assessment and resolution was centered on the drug utilization review (DUR) coordinator and the attending home health nurse. Following guidelines developed by the panel, the DUR coordinator advises the home health nurse about identified problems and how to resolve them. One of these practitioners, usually the nurse, then contacts the attending physician to explain their concerns, offer potential solutions, and request instructions. CONCLUSION: A potentially useful model for the identification and resolution of medication problems in the home health care setting was developed. This model is currently being evaluated in a randomized controlled trial.

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An examination of histamine-2 receptor antagonist use by Medicaid recipients in Wisconsin long-term care facilities.

The Wisconsin Drug Utilization Review Project used Medicaid claims data to examine the use of long-term, full doses histamine-2 receptor antagonists (H2RAs) among long-term care facility (LTCF) residents, ie, doses exceeding 800 mg per day of cimetidine or 150 mg per day of ranitidine for 12 weeks or more. Additional information about a small but representative sample of patients was obtained from consultant pharmacists by mail questionnaire. Of approximately 35,000 residents, there were 1,046 receiving long-term, full-dose H2RAs during 1984 at a cost of +405,848. No differences were noted between treated patients and the overall LTCF population by gender, age, level of care, or geographic locality. Among 387 patients receiving therapy for the last 3 months of 1984, over one half received antacids and over 20% received nonsteroidal anti-inflammatory drugs concurrently. According to survey respondents, almost one half of the patients had no diagnosis amenable to treatment by H2RAs. Diagnostic procedures conducted within 30 days prior to the initiation of H2RAs were hemoglobin/hematocrit assessment (performed on 53% of patients), stool testing (34%), radiological exam (23%) and endoscopy (8%). The results suggest that there is widespread use of long-term full-dose H2RAs in LTCFs for undocumented, inappropriate, and poorly supported diagnoses. Such findings are of concern to all persons charged with monitoring drug use in nursing homes because of the implications for both quality and cost of care. Information from this study will be used in designing a program to reduce inappropriate utilization of H2RAs, and Medicaid claims data will be used to monitor trends in utilization.

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