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Drug utilization review in ambulatory settings: state of the science and directions for outcomes research.

There are escalating national pressures to analyze pharmaceutical outcomes and to develop drug-related clinical guidelines. These interests coincide with passage of the Medicaid Rebate Law (OBRA, 1990), which mandates the implementation of prospective and retrospective drug utilization review (DUR) programs by Medicaid in 1993. This report investigates DUR programs that target outpatient drug therapies. The authors present a conceptual framework that identifies the factors influencing drug prescribing and the range of potential patient outcomes. Current types of DUR interventions and their applications are described, in addition to problems that hinder implementation or evaluation of DUR programs. DUR evaluation studies are reviewed, and a critique identifies the limitations of available DUR research. The authors recommend an expanded DUR policy research agenda, strongly suggesting that priority be given to studies in the following areas: DUR criteria development and validation; prevalence of prescribing problems and their association with patient outcomes; efficacy, toxicity and costs of therapeutic alternatives; and DUR program evaluation. The overall conclusion is that the state of the science pertaining to DUR is not well developed. The potential of DUR may not be realized due to the lack of resources needed to design, implement, and evaluate effective programs. Instead, DUR efforts may be limited to cost-containment issues without due consideration of quality-of-care outcomes. The authors call for rigorous evaluation efforts to inform DUR design and implementation, thereby assuring more rational prescribing and enhancing patient outcomes.

Ambulatory Care Facilities↗

Evaluation of drug utilization and prescribing errors in infants: a primary care prescription-based study.

The purpose of this study is to evaluate the drug utilization trends and to describe the prevalence and type of medication-related prescribing errors in infants treated at primary care health centers in Bahrain. Prescriptions issued for infants were collected over a 2-week period in May 2004 from 20 health centers. Prescribing errors were classified as omission (minor and major), commission (incorrect information) and integration errors. Medications were classified according to the British National Formulary. In infants with a mean age of 6.5 months (+/-3.1) drugs per prescription were 2.52 (+/-1.1). Paracetamol and sodium chloride nasal drops were the topmost prescribed systemic and topical drugs, respectively. In 2282 prescriptions, 2066 (90.5%) were with omission (major), commission, and integration errors. In 54.1% of prescriptions with omission errors, length of therapy was not specified in 27.7%, and in 12.8% the dosage form was not stated. In 43.5% of prescriptions with errors of commission, dosing frequency (20.8%) and dose/strength (17.7%)-related errors were most common. Errors of integration such as potential drug-drug interaction comprised 2.4% of all prescribing errors. The proportion of drugs prescribed irrationally were: contraindicated medications, notably chlorpheniramine, promethazine, and corticosteroids (16.1%); medications prescribed on a p.r.n. basis (13.3%); missed information regarding strength of medications (2.8%); medications prescribed over extended periods (2.7%); low dosing frequency (2.6%); supratherapeutic doses (2.3%); excessive dosing frequency (0.8%). Irrational drug therapy in infants, with prescribing errors were apparent in primary care practice, which may be related to a lack of drug information, pharmacovigilance programme, and nonadherence to basic principles of prescribing. Establishing a national drug policy and pharmacovigilance programme for promoting rational drug use are to be considered. There is also a need to evaluate the effectiveness of interventions by measuring the outcomes.

Bahrain↗

Effect of formulary policy decisions on antimicrobial drug utilization in British Columbia.

BACKGROUND: Formularies are used routinely for management of drug expenditures yet evaluations of their impact remain rare. The objective of this study was to analyse the impact of addition or deletion of antimicrobials from the provincial formulary on drug utilization. METHODS: We obtained data from the British Columbia PharmaNet database on all outpatient oral antimicrobial prescriptions from 1996 to 2000 and converted them to their defined daily dose (DDD) equivalents according to the ATC system. Trends in utilization associated with a changing formulary status of new antimicrobial agents were analysed. Maximum likelihood estimation was used to determine the rate of increase in utilization resulting from addition to the formulary. Models were adjusted for seasonal and temporal trends as well as serial correlation. RESULTS: During this time period, clarithromycin was on formulary, later delisted, and then relisted again. Valaciclovir and famciclovir were also added to the formulary. During the time clarithromycin was off the formulary, the rate of change in its monthly consumption was 0.0061 DDD/1000 population/day; following its relisting, the rate of change increased by 818% to 0.0560 DDD/1000 population/day (P=0.002). After the listing of valaciclovir on the formulary, the rate of change in its monthly consumption increased 57% from a baseline of 0.0014 to 0.0022 DDD/1000 population/day (P=0.07). A similar effect was seen with the addition of famciclovir to the formulary whereby the rate of change in monthly consumption increased from 0.0008 (before addition to the formulary) to 0.0018 (after addition to the formulary) (P </= 0.001). CONCLUSIONS: Listing of antimicrobials on provincial or countrywide formularies is followed temporally with increased utilization. However, before governmental agencies can institute reference-based pricing or co-payment programmes, the effect of such a programme on the emergence of antimicrobial resistance and on patient outcomes needs further study.

Anti-Bacterial Agents↗

Effects of pregnancy on antiepileptic drug utilization.

Pregnancy is associated with characteristic changes in the disposition of antiepileptic drugs; recent findings on this aspect of drug utilization are presented. In one study involving 48 pregnancies, the mean level-dose ratio of phenytoin decreased by 34%. In another study of 111 patients, phenytoin clearance increased gradually over the first 32 weeks of pregnancy and reached twice the preconception value. In two studies with phenobarbital, levels tended to decrease, although this effect was less pronounced than for phenytoin. Similarly for primidone, pregnancy had little effect on steady-state levels; however, levels of phenobarbital formed from primidone exhibited large decreases during pregnancy followed by increases after delivery. This effect was quite consistent. Carbamazepine clearance tended to increase to a relatively small extent. Limited data indicate that valproate levels decrease by 30 to 40% during pregnancy. The mechanisms responsible for these effects have not been elucidated and possibly include decreased bioavailability or compliance, increased metabolic clearance, or decreased plasma protein binding. Since the patient at risk of an increase in seizure frequency cannot be identified prior to conception, therapeutic monitoring is imperative during and after pregnancy.

Anticonvulsants↗

Prospective drug utilization evaluation of three broad-spectrum antimicrobials: cefepime, piperacillin-tazobactam and meropenem.

BACKGROUND: Cefepime, piperacillin-tazobactam and meropenem are among the broadest-spectrum and most expensive antimicrobials. AIM: To evaluate guidelines for appropriate use of these drugs. METHODS: We developed guidelines for use of these antibiotics, and conducted a two-phase drug utilization evaluation. We included all patients who received one of the study drugs during two 3-month periods, with an educational intervention in the intervening period. Appropriateness was determined for initiation of treatment, and for adaptation or continuation of established treatment. RESULTS: Overall, 205 patients received 271 courses with one of these antibiotics, for a total of 709 defined daily doses (DDD) of cefepime, 543 of piperacillin-tazobactam, and 680 of meropenem (8.3, 6.3 and 7.9 DDD/1000 admission days, respectively). Of these 271 courses, 234 were appropriate (86%). Treatment was continued for > or =5 days in 60%, of which 88% were appropriate (NS). Of the 271 courses, 210 (77%) were empirical (83% appropriate), while 61 (23%) were based on a relevant culture result (97% appropriate) (p < 0.001). Appropriateness differed significantly between departments (p < 0.001), and between the two phases (p < 0.001). The major difference between the two surveys was a decrease in meropenem usage (p < 0.05). DISCUSSION: The vast majority of courses with cefepime, piperacillin-tazobactam and meropenem are empirically selected and continued, underlying the importance of an optimal initial choice. Antibiotic guidelines, in conjunction with formal infectious disease consultation, can contribute to more appropriate use of these drugs.

Anti-Bacterial Agents↗

Comparing period prevalences with application to drug utilization.

Period prevalence is frequently measured in studies based on administrative data such as that from health maintenance organizations. For example, treated prevalence and drug utilization prevalence are important measures that are typically defined in relationship to a specified time period. Often one wishes to compare administrative data with period prevalences based on national surveys. It may also be of interest to compare period prevalences from two (or more) different data sources. This comparison is not straightforward owing to the problem of "person-time at risk." This article reviews the values and drawbacks of period prevalence as compared with cumulative incidence. L ife table methodology is described for comparing period prevalence data from administrative databases with survey results. This technique can be extended to the comparison of period prevalence observations from two or more administrative data bases. Examples are given pertaining to hypnotic drug use and the treatment of schizophrenia.

Cross-Sectional Studies↗

Epidemiology of contact allergy: an estimation of morbidity employing the clinical epidemiology and drug-utilization research (CE-DUR) approach.

Clinical epidemiology (CE) is considered unable to estimate morbidity concerning either contact sensitization (CS) or allergic contact dermatitis (ACD) at the population level. Drug-utilization research (DUR) methods estimate the morbidity of suitable diseases based on prescription data for disease-specific drugs. Our objective was to estimate population figures for incidence and prevalence of ACD and CS based on sales data for patch test material in Germany and on patient data from the Information Network of Departments of Dermatology (IVDK). Approximately 600000 standard series are sold per year in Germany, according to the 2 main manufacturers. This raw sales figure was corrected for certain effects (discarded preparations, proportion of formerly patch-tested patients, proportion of patients with ACD seeking medical advice) to obtain an estimate of the denominator of patients eligible for patch testing annually, and combined with patch test results from the Information Network of Departments of Dermatology (IVDK). In 17.8% (of 9266 IVDK patients) ACD was established. Extrapolated to the general population, an incidence of ACD of between 1.7 and 7 per 1000 per year was estimated, depending on whether conservative or more liberal assumptions concerning the above effects were made. Of 78067 IVDK patients tested between 1992 and 2000, 46.8% had at least 1 positive reaction (+ to + + +), and 22.7% had at least 1 stronger positive reaction (+ + or + + +). The 9-year prevalence of CS was estimated to lie between 4.0% and 16.6% for the first outcome, and between 2.0% and 8.1% for the second. Concerning single allergens, 1.9-4.5 million individuals are probably sensitized to nickel, and 1.4-3.4 million to fragrance mix among the German population of 82 million inhabitants. The morbidity data found in this study are in good accordance with data from population-based epidemiological studies. In comparison to these, the CE-DUR approach seems to be an economically feasible method to estimate continuously the population impact of ACD and CS.

Allergens↗

Medicines and culture--a double perspective on drug utilization in a developing country.

A double perspective, one medical-pharmacological and one social-anthropological, is used to understand the logic of drug utilization among practitioners and outpatients at a health unit in Sri Lanka. Both negative and positive aspects of local prescribing practices are highlighted. Western pharmaceuticals are integrated into therapeutic choices for outpatients in Sri Lanka by means of the Ayurvedic theory of balance and practitioners' and patients' behaviour in consultations results in their expectations being met, even if they do not use the same set of health ideas and interpretations of health intervention. The healing power ascribed to Western pharmaceuticals is described and their possible risks discussed from both a biomedical and an anthropological point of view.

Adult↗

Drug utilization review: dipyridamole plus aspirin antiplatelet therapy.

To assess whether dipyridamole was being used appropriately in providing antiplatelet therapy at the San Diego VAMC, a drug utilization review was conducted. Concomitant aspirin therapy was required for dipyridamole to be considered effective in the disease states reviewed. Seventy-three patients on antiplatelet therapy were evaluated, using dosing criteria established through a literature review. Our data indicated tht based on the criteria, only 11% of patients received dipyridamole in appropriate doses; it was underdosed in 89% of patients, and in 19% of patients, it was used when not indicated. In addition, 19% of patients did not receive concomitant aspirin therapy. Results suggest hat dipyridamole is not used optimally in providing antiplatelet therapy to patients in this institution.

Aspirin↗

Trends in consumption of calcium channel blockers in the Czech Republic during 1993-1999 and comparison with selected countries: drug utilization study.

OBJECTIVE: To determine the patterns of consumption in calcium channel blockers (CCB) groups in the Czech Republic between 1992 and 1999 and make a comparison with selected countries. METHODS: This was part of a drug utilization study using WHO methodology [Anatomical Therapeutic Chemical classification/defined daily doses (ATC/DDD)]. The wholesale data collected by drug distributors were used. Utilization was calculated as the DDDs for 1000 inhabitants per day. In focus was the consumption of short-acting nifedipine. Comparison with wholesale data from Finland, Norway, Germany and Australia was made. RESULTS: There was a decreasing tendency to use short-acting nifedipine in the Czech Republic over the period 1993-1999. Four years after publication of warning evidence, short-acting nifedipine still accounted for 23% of all calcium channel blockers in our country. The abundance of second-generation CCBs increased from less than 1% in 1993 to 43% in 1999. The consumption of short-acting nifedipine in the Czech Republic and Germany is probably three times more frequent than in Nordic countries and Australia. CONCLUSIONS: Consumption of short-acting nifedipine in the Czech Republic 4 years after recognition of its risks still remains very high. This suggests that implementation of clinical trial results to clinical practice is very slow and ineffective.

Calcium Channel Blockers↗

Drug utilization by the 30-64 year-old people in two cities in the Federal Republic of Germany in 1984.

A study has been done to describe and compare the drug utilization profiles of the 30-64 yr-old populations in two cities in the Federal Republic of Germany. Subjects from two community surveys, based on random samples in 1984, from the communities of Augsburg in the south, and Luebeck in the north, were asked to bring to interview any medications taken in the preceding seven days. Total drug use in the two communities was very similar. Women took more drugs than men. The drug categories used by at least 5% of men were analgesics/antirheumatics and antihypertensives. The prevalence of use of different drug categories by men was remarkably similar in the two cities, and the only significant difference was a greater consumption of antihypertensive drugs by Luebeck men (9.8%) compared to Augsburg men (6.3%). The drugs taken by at least 5% of women were sex hormones, analgesics/antirheumatics, antihypertensives, thyroid preparations, psychotropics, cardiac drugs and antihypotensives. Consumption by Augsburg women was significantly greater for sex hormones, cardiac drugs, thyroid drugs, and migraine drugs, whereas Luebeck women consumed significantly more antihypertensives. The high use of thyroid drugs by Augsburg women (11%) is indicative of the high frequency of endemic goitre in the southeastern quarter of the FRG. Although it has been shown from sales data that the FRG has a high consumption of cardiac glycosides, the 6% prevalence of use of preparations of them by 30-64 yr-old Augsburg women represents more precise exposure information and reflects a relatively young group of users.

Adult↗

Impact of reference-based pricing for angiotensin-converting enzyme inhibitors on drug utilization.

BACKGROUND: Increasing copayments for higher-priced prescription medications has been suggested as a means to help finance drug coverage for elderly patients, but evaluations of the impact of such policies are rare. The objective of this study was to analyze the effect of reference-based pricing of angiotensin-converting enzyme (ACE) inhibitors on drug utilization, cost savings and potential substitution with other medication classes. METHODS: We analyzed 36 months of claims data from British Columbia for 2 years before and 1 year after implementation of reference-based pricing (in January 1997). The 119,074 patients were community-living Pharmacare beneficiaries 65 years of age or older who used ACE inhibitors during the study period. The main outcomes were changes over time in use of ACE inhibitors, use of antihypertensive drugs and expenditures for antihypertensive drugs, as well as predictors of medication switching related to reference-based pricing. RESULTS: We observed a sharp decline (29%) in the use of higher-priced cost-shared ACE inhibitors immediately after implementation of the policy (p < 0.001). After a transition period, the post-implementation utilization rate for all ACE inhibitors was 11% lower than projected from pre-implementation data. However, overall utilization of antihypertensives was unchanged (p = 0.40). The policy saved $6.7 million in pharmaceutical expenditures during its first 12 months. Patients with heart failure or diabetes mellitus who were taking a cost-shared ACE inhibitor were more likely to remain on the same medication after implementation of reference-based pricing (OR 1.12 [95% confidence interval, CI, 1.06-1.19] and 1.28 [95% CI 1.20-1.36] respectively). Patients with low-income status were more likely than those with high-income status to stop all antihypertensive therapy (OR 1.65 [95% CI 1.43-1.89]), which reflects a general trend toward discontinuation of therapy among these patients even before implementation of reference-based pricing. INTERPRETATION: Reference-based pricing in British Columbia achieved a sustained reduction in drug expenditures, and no changes in overall use of antihypertensive therapy were observed. Further research is needed on the overall health and economic effects of such policies.

Aged↗

Heart failure drug utilization patterns for Medicaid patients before and after a heart failure-related hospitalization.

The authors examined heart failure (HF) drug utilization patterns in Medicaid patients before and after a HF-related hospitalization. This was a retrospective claims analysis of Kansas Medicaid beneficiaries hospitalized for HF between July 1, 2000, and March 31, 2001. HF drugs were tracked 6 months prior and 6 months following the admission. Angiotensin-converting enzyme (ACE) inhibitor doses were compared with target ranges. The cohort of 135 patients had a mean age of 53.6 years and was predominantly female (66.7%) and Caucasian (70.4%) with a high prevalence of cardiovascular comorbidities. Before hospitalization, less than one third of patients were receiving ACE inhibitors, angiotensin receptor blockers, beta blockers, digoxin, or vasodilators. Following hospitalization, increased utilization was observed for beta blockers, digoxin, and angiotensin receptor blockers, but overall usage remained low. ACE inhibitors and vasodilator use remained constant. ACE-inhibitor doses were below target ranges before and after hospitalization. In this Medicaid cohort, HF-related hospitalizations did not lead to improved HF therapy.

Adult↗

Drug utilization review of concomitant use of specific serotonin reuptake inhibitors or clomipramine with antianxiety/sleep medications.

Side effects of some antidepressants include anxiety and insomnia. A retrospective drug utilization review was conducted to determine the amount of concurrent use of an antidepressant with medication that may counteract these side effects. Texas Medicaid claims data for 1993 included more than 30,000 patients receiving a specific serotonin reuptake inhibitor (SSRI) or clomipramine. A total of 35.0% of these patients were also taking a medication that could be used to relieve anxiety or induce sleep, and 15.2% of the total were receiving once-daily dosing of the latter type of medication. Concomitant use of SSRIs or clomipramine with trazodone occurred in 7.7% of the patients.

Anti-Anxiety Agents↗