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What does the Medicare prescription drug legislation mean for the American cardiologist?

The Medicare Modernization Act of 2003 authorized the most sweeping changes to the Medicare and Medicaid programs since their inception in 1965. One key feature, a prescription drug benefit, will begin enrolling seniors in November 2005, and the benefit will begin in January 2006. This benefit will have complex and largely unknown effects on medication adherence in the elderly. It has a complex system of copayments and deductibles and subsidy eligibility requirements, as well as a "donut hole." Drug coverage for people dually eligible for Medicare and Medicaid will change greatly. Medicare beneficiaries will have to choose from a large, bewildering choice of prescription plans and many will turn to their physicians for advice. This article details the background, benefits, and expected impact of all of these aspects of the new Medicare Part D prescription drug benefit.

Aged↗

Primary care in the treatment of functional gastrointestinal symptoms in Japan: prescription preferences and impression of results.

BACKGROUND: Functional gastrointestinal (GI) disorders are common in primary care. However, proper pharmacological approaches have not yet been established. The reason for a lack of proper approaches may be attributable to the lack in clarity of their pathogenesis and pathophysiology. Meta-analysis of pharmacological approaches to functional GI disorders failed to identify the solid cluster of patients' symptoms. AIM: The aim of this study is to assess the perspective of primary care doctors concerning prescriptions for functional GI symptoms, evaluate the efficacy of the drugs prescribed, and the need for medication for these symptoms. METHOD: Questionnaires were sent to primary care doctors, and a total of 149 responses were obtained. Efficacy of each medication was evaluated by the number of doctors favouring the category, and the respective impressions of prescriptions given. RESULTS: Symptoms of heartburn were well controlled by anti-secretory drugs (H2RAs and PPIs), while appetite loss and abdominal gurgling were not controlled by any medications. CONCLUSIONS: This survey reveals differences in need for various prescription drugs in functional GI symptoms.

Abdominal Pain↗

Food and Drug Administration surveillance of dermatology-related and nondermatology-related prescription drug advertising in the USA, 2000-2003.

BACKGROUND: Spending on advertising of prescription medicines in the U.S.A. is increasing by nearly a billion dollars yearly. The Food and Drug Administration (FDA) is legally mandated to regulate pharmaceutical advertising in the U.S.A. Prior studies have documented inaccuracies in pharmaceutical advertisements, in the U.S.A. and the rest of the world. OBJECTIVES: To assess trends in FDA surveillance of dermatology-related prescription drug advertising, and to investigate pharmaceutical companies' responses to FDA regulatory actions. METHODS: We analysed all FDA citations of prescription drug advertisements issued during 2000-2003, and responses from cited companies to our mailed requests for follow-up information. RESULTS: Twenty-four dermatology-related drugs from 21 companies accounted for 30 (15.2%) of the 198 letters sent by the FDA; of these, 18 letters cited advertisements or promotions of these medications for dermatology-related uses. The most common violation cited overall was insufficient communication of risk (32.4% overall, 33.9% dermatology-related). Most FDA letters cited physician-targeted advertising (71.6% overall, 62.1% dermatology-related). The number of dermatology-related letters sent declined by 69.2% from 2000 (n=13) to 2003 (n=4), paralleling the 69.6% decline in the total number of letters sent (n=79 in 2000, n=24 in 2003). Compared with 2000, the FDA took longer to issue citation letters in 2003 for advertisements overall [hazard ratio (HR) 0.47, 95% confidence interval (CI) 0.27-0.72, P=0.001], although this trend was not present for dermatology-related advertisements (HR 1.12, 95% CI 0.39-3.29, P=0.83). Eight of the 16 companies (50%) that received requests from the authors for information replied. Seven of the eight (87.5%) reported complying with FDA requests to discontinue the cited advertisements, while one (12.5%) reported disagreeing with the citation and successfully clarifying the issue with the FDA. CONCLUSIONS: Dermatology-related advertisements accounted for 15.2% of FDA citations of pharmaceutical advertisements between 2000 and 2003. Recent controversy over pharmaceutical advertising may lead to changes in pharmaceutical advertising practices and surveillance of pharmaceutical advertising in the U.S.A.

Advertising↗

Computer-based drug management in a bone marrow transplant unit: a suitable tool for multiple prescriptions even in critical conditions.

Drug prescription or administration errors are the most common causes of adverse events for hospital patients. Computer-based systems can be effective in reducing these errors. The aim of this study was to assess whether computer-based systems are easily exploitable even in critical conditions. The oral and handwritten system for drug management was completely replaced by a computer-based system in our bone marrow transplant unit, chosen because: (i) the intensive treatments could test the efficiency of the system; (ii) the very frequent occurrence of complications and emergencies could test the flexibility of the system; and (iii) the pre-existing system could be used as comparison. From May to November 2002, 41 patients were repeatedly admitted to undergo high-dose chemotherapy, autologous/allogeneic stem cell transplantation or because of severe complications. In 27 consecutive admissions, 2264 drug prescriptions (average, 29 drugs/patient admission) and 36 786 drug administrations (39.8/patient/d) were carried out. Despite the large number of procedures, the computerized system effectively replaced the oral and handwritten transmission of information among medical staff, pharmacists and nurses, and lowered the error risks. In addition, it contributed to medical updating through warnings on potential problems in case of multiple drug prescriptions, and gave the pharmacy a valuable tool to monitor drug use.

Adult↗

Prescription of oral corticosteroids in near-fatal asthma patients: relationship with panic-fear, anxiety and depression.

Oral corticosteroids are the most effective drugs for illness management, especially in near-fatal asthma (NFA) patients. Prescription of oral corticosteroids in other groups of asthmatic patients has been shown to be related not only to clinical features of the illness, but also to psychological variables, what suggests the need to investigate this relationship specifically in NFA patients. Forty-two NFA patients aged 18--83 were interviewed to collect data on sociodemographics, clinical features and psychological variables, specifically panic-fear, anxiety and depression; 45.2% had been prescribed oral corticosteroids and 54.8% had not been prescribed this type of medication. Only frequency and severity of symptoms (odds ratio=3.14; 95% confidence interval=1.27-7.79; p=0.013) and state-anxiety (odds ratio=1.03; 95% confidence interval=1.03-1.29; p=0.015) emerged as significant risk indicators for the prescription of oral corticosteroids. These preliminary results in NFA patients confirm previous reports about the relationship between prescription of oral corticosteroids and psychological variables in asthmatic patients. State-anxiety could increase the magnitude of breathing difficulties, and thus imply the need for more effective medications for its management, but further research is necessary to reject other possible explanations.

Administration, Oral↗

Randomized controlled trial of an informatics-based intervention to increase statin prescription for secondary prevention of coronary disease.

OBJECTIVE: Suboptimal treatment of hyperlipidemia in patients with coronary artery disease (CAD) is well documented. We report the impact of a computer-assisted physician-directed intervention to improve secondary prevention of hyperlipidemia. DESIGN AND SETTING: Two hundred thirty-five patients under the care of 14 primary care physicians in an academically affiliated practice with an electronic health record were enrolled in this proof-of-concept physician-blinded randomized, controlled trial. Each patient with CAD or risk equivalent above National Cholesterol Education Program-recommended low-density lipoprotein (LDL) treatment goal for greater than 6 months was randomized, stratified by physician and baseline LDL. Physicians received a single e-mail per intervention patient. E-mails were visit independent, provided decision support, and facilitated "one-click" order writing. MEASUREMENTS: The primary outcomes were changes in hyperlipidemia prescriptions, time to prescription change, and changes in LDL levels. The time spent using the system was assessed among intervention patients. RESULTS: A greater proportion of intervention patients had prescription changes at 1 month (15.3% vs 2%, P=.001) and 1 year (24.6% vs 17.1%, P=.14). The median interval to first medication adjustment occurred earlier among intervention patients (0 vs 7.1 months, P=.005). Among patients with baseline LDLs >130 mg/dL, the first postintervention LDLs were substantially lower in the intervention group (119.0 vs 138.0 mg/dL, P=.04). Physician processing time was under 60 seconds per e-mail. CONCLUSION: A visit-independent disease management tool resulted in significant improvement in secondary prevention of hyperlipidemia at 1-month postintervention and showed a trend toward improvement at 1 year.

Adult↗

Regulating opioid prescribing through prescription monitoring programs: balancing drug diversion and treatment of pain.

Social policies have evolved to address the associated concerns related to the public health crises of drug abuse and undertreated pain. Prescription monitoring programs (PMPs) have been used for many years in this effort but are undergoing re-evaluation and restructuring in light of changes in technology as well as changes in our understanding of the collateral impact of such programs. We reviewed the state of PMPs in the United States and highlighted recent changes in these programs that have occurred nationally. The current changes occurring in California, with the most physicians of any U.S. state as well as the oldest triplicate-based serialized prescription program, are reviewed, with focus on the transition to tamper-resistant prescriptions that use security paper forms. Future trends for PMPs are described, including the potential for widespread use of electronic prescribing, which is gaining favor with the Drug Enforcement Agency.

Analgesics, Opioid↗

Simulated discharge system of prescription and long-term drug treatment in a psychiatric hospital.

The drug sheets of patients resident in a psychiatric hospital for more than 1 year were reviewed. The simulated discharge system involving the re-writing of drug sheets every 12 weeks was in operation, but there was only a slight increase in prescription changes at the time of renewal; 35.4% of prescriptions had been unchanged for 1 year and 4.3% for 5 years. A high proportion of long-term prescriptions were for purgatives, hypnotics and neuroleptics.

Antidepressive Agents↗

Effect of an educational program for general practitioners on Gotland on the pattern of prescription of psychotropic drugs.

During the years 1983-1984, an educational program was given to all general practitioners on the island of Gotland. This report evaluates changes in prescription habits from 1982 to 1985. To correct for general trends that occurred simultaneously, the prescription habits were compared to the habits in the rest of Sweden. Both on Gotland and in Sweden as a whole, the use of antidepressants increased from 1982-1985, but significantly more on Gotland. In 1982, the use of antidepressants was low on Gotland, 54% of that in the rest of Sweden. After the educational programs, Gotland reached 77% of the use in the rest of Sweden. In 1982, the use of lithium was 123% of that in the rest of Sweden. After the educational programs, the use of lithium was unchanged, and a small increase of 5.6% was seen in the rest of Sweden. After the educational programs, the prescription of sedatives on Gotland decreased (-8.2%), and an increase of 4.5% was seen in the rest of Sweden. The use of major tranquilizers also decreased significantly (-23%) on Gotland. Even in the rest of Sweden, a significant but much smaller decrease was seen: -13%. On Gotland the frequency of hypnotics remained stable from 1982-1985, and a significant increase was seen in the rest of Sweden.

Antidepressive Agents↗

Critical steps in fluoroquinolones and carbapenems prescriptions: results from a prospective clinical audit.

Antibiotic misuse is associated with emergence of resistance and high expenditures. Fluoroquinolones (FQ) and carbapenems (CP) are drugs with considerable potential of resistance development and its disseminated use is a concern. We undertook a prospective clinical audit to evaluate prescriptions of FQ and CP in a multistep process. Each prescription was unfolded in the following steps: indication for antimicrobial therapy; adequacy of initial prescription, dosage and route; previous cultures; and parenteral-oral transition. There was no antibiotics indication in 8.9% of FQ and 1.5% of CP group (p = 0.07). In CP 25.8% of initial schemes were inappropriate (21% in FQ). Lack of switch to oral therapy comprised 25% of monthly costs of FQ. Inadequacy in initial choice accounted for 13.6% of CP expenses. We concluded that, in spite of infection control restrictive policies, inappropriateness of antibiotic usage is worrisome. Clinical audit in a multistep approach may identify possible flaws in this process.

Anti-Bacterial Agents↗

Templates for analysis of individual-level prescription data.

The advent of large population-based prescription databases has enabled us to study drug use with the individual user as our unit of analysis. This review presents three non-specific analytic templates that may be applied to individual-level prescription data. The ratio of prevalence odds to incidence rate can estimate the average duration for drug use. Limitations and pitfalls are discussed. Although it should be cautiously interpreted, it provides a reasonable ranking of drugs with respect to their retention in users. The Lorenz curve is an analytic tool to express skewness in drug use. It shows the proportion of drug use that is accounted for by percentiles of drug users, ranked according to their volume of drug intake. It may express the extent of heavy users as well as sporadic small-volume users and may, for example, be used to screen for an unsuspected abuse potential of a drug. The waiting-time distribution is a frequency distribution of first occurrences of drug use within a time-window. It forms the basis for a theoretical model for robust estimates of prevalence and incidence rate. On an intuitive level, it displays visual correlates of epidemiological prescribing parameters such as period prevalence, point prevalence, incidence rate, duration, prescription renewal rate, relapse of treatments and seasonality. Each measure may be incorporated into an integral matrix that reflects various traits in utilization of every drug or drug class, thereby possibly finding abnormalities that suggest sub-optimal prescribing.

Data Interpretation, Statistical↗

A comparative analysis of nurse practitioners with and without prescriptive authority.

This article reports findings from a national random sample of nurse practitioners (NPs) who were actively practicing in adult primary care settings during 1986. An analysis of their demographic and practice characteristics revealed a statistically significant association between certain characteristics and the NPs' prescribing status. Nurse practitioners with prescriptive authority had more years of experience and were more likely to practice in rural or suburban areas and work in nongroup settings than NPs without prescriptive authority. These findings suggest that giving NPs' prescriptive authority may be an enabling factor that supports NP practice in medically underserved locations.

Drug Prescriptions↗

Identifying the drug seeker: the advanced practice nurse's role in managing prescription drug abuse.

PURPOSE: To provide advanced practice nurses (APNs) with a definition of drug-seeking behaviors, to identify the common signs and symptoms of drug-seeking behaviors, to furnish tips for managing interactions with and treatment of the drug-seeking patient, and to describe prescription parameters that will help APNs avoid legal ramifications. DATA SOURCES: A review of the current scientific and clinical literature regarding interaction with and treatment of patients who abuse prescription drugs. CONCLUSIONS: A basic understanding of drug-seeking behaviors and adherence to appropriate procedures for prescribing controlled medications are essential for APNs to maintain their safe prescribing habits; carry on with quality, effective care; and continue the advancement of their profession. IMPLICATIONS FOR PRACTICE: As primary care providers, APNs must be aware of the potential complications resulting from interacting with patients who may be seeking prescription drugs for recreational or illicit use, rather than for legitimate reasons.

Attitude to Health↗

Prescriptive patterns of nurse practitioners and physicians.

PURPOSE: To compare the prescriptive patterns of nurse practitioners (NPs) and physicians in a primary care setting for the treatment of sinusitis, bronchitis, musculoskeletal injury, and back pain. DATA SOURCES: One hundred charts were reviewed for each condition for a total of 400 charts (200 of the charts were for NP providers, and 200 were for physician providers). CONCLUSIONS: While the mean scores of the differences in prescriptive patterns were found to be statistically significant in only one instance, the overall findings indicate slight differences in the administration of medications for patients. Additionally, NPs prescribed more over-the-counter medications and provided more nonpharmacotherapeutic interventions for their patients than the physicians. IMPLICATIONS FOR PRACTICE: The results, although statistically significant in only one category, indicate that NPs may be more cautious in their prescriptive interventions and provide more teaching for patients.

Adolescent↗

How the FDA and the ADA affect development of prescription drugs for oral care.

The patient-consumer, the health professional, and the producer are all essential in the world of prescription drugs for oral care. Also essential are the Food and Drug Administration (FDA) and the American Dental Association (ADA). The FDA is charged with reviewing new-drug applications in the United States and approving those drugs that are proved safe and effective. The FDA also controls prescription-drug advertising and promotion. The ADA applies professional standards in judging all submitted dental drugs. Those drugs accepted by ADA's Council on Dental Therapeutics may display the ADA seal in labeling and advertising. All advertising for accepted products must be cleared by the ADA. An example of a prescription drug approved by the FDA and accepted by the ADA is 0.12 percent chlorhexidine gluconate oral rinse (Peridex). This drug followed the FDA's investigational-drug (IND) regulations before final approval as a treatment for gingivitis.

American Dental Association↗

A decline in mupirocin resistance in methicillin-resistant Staphylococcus aureus accompanied administrative control of prescriptions.

Susceptibility to mupirocin was assessed in methicillin-resistant Staphylococcus aureus isolates selected from eras corresponding to differences in usage rate and prescription policies at a Veterans Affairs medical center. The eras studied encompassed from the time of introduction of the drug to its widespread use, through recommended judicious use, and finally to subsequent stringent administrative control. Prescriptions declined from 3.0 to 0.1 per 1,000 patient days. Precipitous declines first in the numbers of isolates with high-level resistance (from 31% to 4%) and then in those with low-level resistance (from 26% to 10%) accompanied prescription control.

Bacterial Proteins↗

Improving doctors' prescribing behaviour through reflection on guidelines and prescription feedback: a randomised controlled study.

BACKGROUND: It is difficult to put research findings into clinical practice by either guidelines or prescription feedback. AIM: To study the effect on the quality of prescribing by a combined intervention of providing individual feedback and deriving quality criteria using guideline recommendations in peer review groups. METHODS: 199 general practitioners in 32 groups were randomised to participate in peer review meetings related to either asthma or urinary tract infections. The dispensing by the participating doctors of antiasthmatic drugs and antibiotics during the year before the intervention period provided the basis for prescription feedback. The intervention feedback was designed to describe the treatment given in relation to recommendations in the national guidelines. In each group the doctors agreed on quality criteria for their own treatment of the corresponding diseases based on these recommendations. Comparison of their prescription feedback with their own quality criteria gave each doctor the proportion of acceptable and unacceptable treatments. MAIN OUTCOME MEASURE: Difference in the prescribing behaviour between the year before and the year after the intervention. RESULTS: Before intervention the mean proportions of acceptably treated asthma patients in the asthma group and urinary tract infection (control) group were 28% and 27%, respectively. The mean proportion of acceptably treated patients in the asthma group was increased by 6% relative to the control group; this difference was statistically significant. The mean proportions of acceptable treatments of urinary tract infection before intervention in the urinary tract infection group and asthma (control) group were 12% for both groups which increased by 13% in the urinary tract infection group relative to the control group. Relative to the mean pre-intervention values this represented an improvement in treatment of 21% in the asthma group and 108% in the urinary tract infection group. CONCLUSIONS: Deriving quality criteria of prescribing by discussing guideline recommendations gave the doctors a basis for judging their treatment of individual patients as acceptable or unacceptable. Presented with feedback on their own prescribing, they learned what they did right and wrong. This provided a foundation for improvement and the process thus instigated resulted in the doctors providing better quality patient care.

Asthma↗

Prescription of oxygen concentrators: adherence to published guidelines.

The indications for the prescription of oxygen concentrators have been assessed in 82 patients against the Department of Health guidelines, except that only one set of blood gas and spirometry measurements was required if the patient's condition was stable. Of the 49 patients recommended for this treatment by a chest physician, 41 (82%) fulfilled the requirements, compared with only 11 of 33 patients where the concentrator was recommended by a general practitioner or non-specialist physician. Eleven patients died within one month of prescription. The results show that many patients are being prescribed oxygen concentrators without assessment and underline the importance of full assessment and attention to prognosis before prescription.

Adult↗