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Drug prescription in diabetic patients in Stockholm in 1992 and 1995--change over time.

OBJECTIVE: To describe and compare the distribution of prescribed drugs in diabetic patients between 1992 and 1995. METHODS: Two cross-sectional surveys of a random selection of medical records of diabetic patients, from three community health centres (CHCs) in the Stockholm metropolitan area, were carried out. The age of the subjects ranged from 20 to 84 years. The number of prescriptions of pharmaceutical preparations given to the diabetic patients was noted, as well as classification of the diabetes, the metabolic outcome, and concomitant hypertension. RESULTS: Between 1992 and 1995, the use of oral antidiabetics increased significantly from 43 to 57% of the patients and the rate of treatment with diet only decreased from 30 to 20%. Combination treatment with oral drugs and insulin rose significantly from 1 to 8% of the patients. However, the greatest increase observed between 1992 and 1995 concerns cardiovascular drugs. The prescription rate of ACE inhibitors increased from 5 to 21%, of loop diuretics from 19 to 28%, of ASA from 9 to 21%, and of lipid-lowering agents from 1 to 7%. There was also a considerable variation between the three CHCs. Despite the more aggressive diabetic treatment strategies, the metabolic state was unchanged and unsatisfactory for 40-50% of the patients. CONCLUSIONS: There have been major changes towards more active pharmacological treatment regarding antidiabetic, cardiovascular, and lipid-lowering agents.

Adolescent↗

Medical-legal issues in headache: penal and civil Italian legislation, working claims, social security, off-label prescription.

Primary headaches can be considered simultaneously as symptom and disease itself, while secondary headaches are expressions of a pathological process that can be systemic or locoregional. Because of its subjective features, headache is often difficult to assess and quantify by severity, frequency and invalidity rate, and for these reasons it has often been implicated in legal controversies. Headache has seldom been considered in the criminal law, except when it represents a typical symptom of a disease whose existence can be objectively assessed (i. e. raised intracranial pressure). Therefore, in civil legislation it is not yet coded to start claiming for invalidity compensation. In particular, one of the most debated medical-legal questions is represented by headaches occurring after head injury. Headache is often the principal symptom at the beginning of several toxic chronic syndromes, with many implications, especially in working claims, and, more recently, it may be referred to as one of the most frequent symptoms by victims of mobbing (i. e. psychological harassment in the workplace). The National Institute for Industrial Accident Insurance (INAIL) scales (instituted by the law 38/2000) mention the "Subjective cranial trauma syndrome" and give an invalidity rate evaluation. With reference to other headache forms, no legislation really exists at the present time, and headache is only considered as a symptom of a certain coded disease. Requests for invalidity social pension and the question of off-label prescriptions (drug prescription for a disease, without formal indication for it) are other controversial matters.

Disability Evaluation↗

Validity of parental-reported questionnaire data on Danish children's use of asthma-drugs: a comparison with a population-based prescription database.

The aim of this study was to examine the validity--estimated as the sensitivity, specificity, and predictive values--of questionnaire-based parental reporting on Danish children's use of asthma drugs. Within a population-based cross-sectional study on the association between asthma and dental anxiety, we compared parental answers on their children's use of asthma drugs during the past 12 months with National Health Service (NHS) data from a prescription database on prescriptions of inhaled beta 2-agonists, inhaled corticosteroids, or both for a period of 14 months preceding the date of posting the parental questionnaires. In four municipalities in North Jutland County, Denmark, in 2001, parents of 1273 children between the ages of 6 and 8 years completed the questionnaire. For frequency of use, the sensitivity increased from 57.9% (95% confidence interval [CI]: 47.8-67.3%) for the answer 'Every day' to 91.6% (95% CI: 84.3-95.7%) when the answers 'Every day', 'Often', and 'Sometimes' were combined. The specificity exceeded 95.9% (95% CI: 94.6-96.9%) for all answers. The positive predictive value (PPV) increased from 64.4% (95% CI: 56.1-72.0%) when the answers 'Every day', 'Often', and 'Sometimes' were combined to 94.8% (95% CI: 85.9-98.2%) for the answer 'Every day'. The negative predictive value (NPV) both exceeded 96.7% (95% CI: 95.5-97.6%) for all answers. Questionnaire-based parental reporting on children's one-year asthma-drug use appears to be valid in epidemiological research depending on the study question and design.

Anti-Asthmatic Agents↗

PTSD, depression, prescription drug use, and health care utilization of Chinese workers affected by the WTC attacks.

This study assessed the impact of the World Trade Center (WTC) attacks on emotional problems, prescription drug usage, and utilization of medical and mental health services within the Chinese community in lower Manhattan. We administered a survey to 148 randomly selected Chinese workers affected by the WTC attacks in March 2003. Although nearly half of the respondents had elevated PTSD and/or elevated depression scores, only a few (4.4%) had talked to a counselor. However, nearly all (86%) reported having visited a physician at least once since September 11, 2001. Individuals with elevated PTSD scores were significantly more likely to have gone to a physician after 9/11. They were also more likely to have received prescription drugs and to indicate an interest in counseling after 9/11 than individuals with low PTSD scores. The findings highlight the role of the primary care physician as gatekeeper for mental health symptoms after a disaster. They further suggest that primary care physicians should use screening tools for depression and posttraumatic stress after a major disaster and that they should be sensitive to potential emotional problems that are associated with somatic complaints.

Adult↗

Interdisciplinary perceptions of the dietitian's legal responsibility for lethal dietary prescription errors for patients with end-stage renal disease.

OBJECTIVE: To determine intergroup and intragroup consensus for interdisciplinary perceptions of dietitians' legal responsibility for lethal dietary prescription errors. DESIGN: Survey research was conducted by a mail questionnaire containing four hypothetical cases in which the dietitian provides a lethal amount of dietary potassium for an anephric patient. SETTING: Of the 90 New York State end-stage renal disease facilities contacted, 64 returned one or more questionnaires. SUBJECTS/SAMPLES: Usable questionnaires were tabulated from 51 registered dietitians, 39 registered head nurses, and 43 physician-medical directors. MEASURES: Consensus was recognized when 60% or more of the responses occurred in one extreme collapsed and dichotomized category of "yes" or "no" regarding the dietitian's legal responsibility. STATISTICAL ANALYSES PERFORMED: Intergroup and intragroup consensus levels were compared by frequency, mean, standard deviation, and Scheffe test of differences. RESULTS: The triad groups met varying levels of consensus on all four scenarios, with dissenting opinions by nurses on two scenarios. The dietitians and the physician-medical directors had mirror-image perceptions that the dietitian was not legally accountable for two cases of following foreseeably lethal dietary prescriptions "as written." Eight dietitians viewed the dietitian as legally nonculpable for causing a patient's death because of the dietitian's sole incompetence or carelessness in making a serious calculation error. Nurses met the highest levels of agreement and perceived the dietitian to be legally accountable for all four cases. The nurses, in contrast to the dietitians and physician-medical directors, held opinions of dietitian legal responsibility as consistent with the standard of care expectations of prudent health care professionals defined by professional malpractice jurisprudence. APPLICATIONS/CONCLUSIONS: The data indicate that to protect both the patient and the professional, there is a notable need for greater understanding dietetics jurisprudence.

Dietetics↗

Physiologic responses to recumbent versus upright cycle ergometry, and implications for exercise prescription in patients with coronary artery disease.

To clarify the influence of body position on exercise prescription, 14 men (mean age +/- standard deviation 60.0 +/- 6.1 years) with coronary artery disease who underwent randomized recumbent and upright cycle ergometer tests to volitional fatigue were studied. At 100 watts, heart rate (HR), systolic blood pressure, oxygen consumption (VO2), rate pressure product and rating of perceived exertion were greater (p less than 0.05) in the upright than in the recumbent position. At peak exercise, however, these variables were not significantly different. Regressions of relative HR versus VO2 for recumbent and upright cycle ergometry were comparable: y = 1.24x - 32.7 and y = 1.26x - 31.5, respectively, where y = % maximal VO2, and x = % maximal HR. These findings indicate that recumbent exercise prescriptions may be based on the peak HR and VO2 values obtained during upright cycle ergometry, and vice versa. However, differences in the cardiorespiratory responses at submaximal exercise preclude the interchangeability of upright and recumbent training work rates.

Aged↗

Fate of a ferrous sulfate prescription.

Prescriptions for ferrous sulfate, 300 mg, were filled with eight different preparations by 15 pharmacies. Only three types of pills had a reasonably rapid dissolution time in acid media and these were all obtained from university-associated pharmacies. Some form of "slow release" or "enteric coat" feature was present in the pills and capsule supplied by private pharmacies and the Veterans Administration Hospital pharmacy. Adding the phrase "not enteric-coated" to the prescription effected no change in the type of pill supplied. Prices were highly variable, even for the same preparation, and although all generic pills were cheaper than brand-name pills, the "supermarket" type pharmacies charged as much or more for the pills as individually owned pharmacies.

Costs and Cost Analysis↗

Remedying the Achilles heel of behavior research and therapy: prescriptive matching of intervention and psychopathology.

Recent calls for eclecticism in clinical practice have been fueled by the putative limitations of behavioral techniques in treating a variety of psychological problems. However, calls for such integration do not appear to be justified for two related reasons. First, the precise conditions under which behavioral interventions are and are not effective have not yet been adequately delineated. Consequently, rejection of behavioral interventions in favor of relatively indiscriminate application of cognitive strategies is premature. Second, behavior therapy has as its hallmark a thorough grounding in inductive empiricism, while cognitive/dynamic theories are wholly based in deductive rationalism. As a result, wholesale acceptance of alternative theories and techniques by behaviorists is both inconsistent and retrogressive. Cognitive interventions have their place, but only when cognitive distortions have been specifically identified. Therefore, refinement of behavioral treatments into prescriptive interventions is warranted. The parameters of prescriptive behavior therapy are described in this paper.

Behavior Therapy↗

Local control, TCD50 and dose-time prescription habits in radiotherapy of head and neck tumours.

Clinical data on head and neck tumours presented by Withers et al. (The hazard of accelerated tumour clonogen repopulation during radiotherapy. Acta Oncol. 27: 131-146, 1988) are reexamined. Recently it was argued that the relationship between TCD50 and treatment time might be influenced by the practice of prescription [3,4]. This paper investigates the role of local tumour control rate in the interpretation of the data. In the genuine data set local tumour control rates were replaced by either tumour failure rate or by random numbers. TCD50 values were calculated from the original and these manipulated data and related to treatment duration. TCD50 increases with about 0.48 Gy/day in all cases. This unexpected result is explained by the lack of a dose-response relationship which causes a highly significant correlation between TCD50 and prescribed dose. Consistently, multiple regression analysis reveals a significant impact of prescribed dose (p < 0.0001) on TCD50 but not of treatment duration (p > 0.05). The increase of TCD50 with treatment time reflects solely dose-time prescription habits. The data provide no significant evidence either for an impact of treatment duration or for repopulation during radiotherapy in head and neck tumours. From this lack of evidence it may not be concluded that treatment duration is an unimportant parameter in radiotherapy.

Dose-Response Relationship, Radiation↗

Switching drugs from prescription-only to over-the-counter availability: economic benefits in the United Kingdom.

Recent years have seen suggestions that legislation restricting certain drugs to prescription-only availability should be relaxed. This paper estimates the economic benefits of such changes, with specific reference to two drugs recently switched in the United Kingdom: Ioperamide and 1% topical hydrocortisone. The findings suggest that making these products available from the pharmacy without a prescription has resulted in substantial benefits by reducing costs to consumers and saving general practitioners' time. In view of these benefits, the disadvantages of such changes should be evaluated.

Administration, Topical↗

OPADE: optimization of drug prescription using advanced informatics.

The computerized drug prescription system (CDPS) is an old, almost obsolete, dream, and numerous researchers have developed prototypes or even full fledged packages. But few systems are currently used in clinical practice. The OPADE project, presented in this paper, aims at developing a computerized system which allows for optimization of drug prescription from a medical, patient compliance and economical point of view; the system will be adapted to different European countries, integrated and customized to local medical practice so as to insure user acceptance.

Computer Systems↗

Prescription drug advertising: trends and implications.

Prescription drug advertisements which appeared in two leading American medical journals in 1972, 1977 and 1982 were analyzed to discover possible trends in advertising. The 5016 ads examined showed that ads for the diuretic-cardiovasculars, especially the beta-adrenergic blocking agents and the slow channel inhibitors, as well as the analgesics, had increased, while ads for the anti-infectives and tranquilizers had diminished. The average amount of space allocated for each ad had increased. On the average, most ads (69%) depicted neither male nor female patients in their graphics, and a trend of increased neutrality was observed. When the hormones were excluded, an average of 21% of the ads showed male patients and 10% showed females. Since a relationship was discerned between the leading drugs advertised and the leading prescriptions filled, it was concluded that advertising does have some effect on the prescribing behavior of practitioners. The findings suggest that great investment in advertising is necessary in order to achieve high levels of sales for such drugs as Valium (diazepam) which do not have a clear-cut ameliorative effect on a specific physiological condition. On the other hand, it was suggested that saturation advertising would not significantly enhance the sales of such drugs as Dyazide (triamterene and hydrochlorothiazide) because of its well established therapeutic value in the control of hypertension. Ten advertising companies, on the average, had purchased 67% of all advertising space and five had purchased almost half (47%). The same two pharmaceutical companies were among the top five advertisers and the same five were among the top ten for the three years studied.

Advertising↗

The influence of patient and physician gender on prescription of psychotropic drugs.

There is a wealth of evidence that more psychotropic drugs are prescribed to female than to male patients. We studied the psychotropic drug prescription of 15 male and 9 female physicians to 2493 patients in the Ambulatory Care Clinic of a University hospital. The relative odds (RO) of benzodiazepine prescription to a female compared to a male patient was the same when the physician was a male or a female (adjusted RO: 1.8; 95% CL: 1.5-2.1). But female patients were significantly more likely to be prescribed psychotropic drugs of all types from a female than from a male physician (adjusted RO: 1.3; 95% CL: 1.0-1.7). Information on patient diagnosis or on severity of symptoms would be needed to determine whether the present results reflect gender differences in medical care needs, overprescription of psychotropic drugs to females or underprescription of psychotropic drugs to males.

Attitude of Health Personnel↗

Predictors of prescriptions for management of fatigue among veterans with multiple sclerosis.

OBJECTIVE: To determine predictors of fatigue-modifying medication use. DESIGN: Cross-sectional cohort. SETTING: Veterans Health Administration (VHA) facilities. PARTICIPANTS: Veterans with multiple sclerosis (MS) in the VHA in the northwestern United States from 1995 to 2000. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A self-administered survey distributed by mail sought information from veterans with MS about demographics, symptoms, barriers to care, and disease characteristics. The variables were compared with prescriptions for fatigue-modifying medications during the study period. RESULTS: Of 1032 patients, 451 (44%) completed the survey, and 306 (68%) reported moderate or high fatigue levels. Only 40% of the 306 were prescribed fatigue-modifying medications. Those using specialized fatigue services or who received care at tertiary centers were more likely to receive fatigue treatments. Patient-perceived barriers to accessing care and other patient characteristics were not associated with prescription rates. CONCLUSIONS: Fatigue is undertreated among veterans with MS. However, there is considerable variability in the provision of fatigue care. Interventions to improve the quality and uniformity of fatigue care are warranted.

Adult↗

Treatment of depressive disorders in split versus integrated therapy and comparisons of prescriptive practices of psychiatrists and advanced practice registered nurses.

This study examined the differences in adherence to medication for the treatment of depressive mood disorders whether the patient was involved in split or integrated therapy and if the patient was being treated by a psychiatrist or an advanced practice registered nurse (APRNs) in psychiatry with prescriptive authority. The sample consisted of 122 adults ages 20-60 who carried a diagnosis of major depression, dysthymia, or bipolar II disorder, voluntarily treated in the private sector. Chi-square was the measure used to assess differences in adherence. Adherence was determined by documentation from chart reviews, retrospectively, of the prescriptions for psychotropic medication for a period of up to nine months for each patient included in the research. Six psychiatrists and six APRNs volunteered to collect data from their private practices. Findings demonstrated no statistically significant differences in patient's adherence to medication if they were in split or integrated treatment or if either psychiatrists or an APRN treated them. Psychiatrists used more of secondary class of antidepressants and more antianxiety agents than did the APRNs. The nurses spent more time with patients, using more integrated therapy, than did the psychiatrists.

Adult↗

Effect of phenytoin on mood and declarative memory during prescription corticosteroid therapy.

BACKGROUND: In humans and animals, corticosteroid excess is associated with impairment in declarative memory and changes in hippocampal structure. In animals, phenytoin pretreatment blocks the effects of stress on memory and hippocampal histology, although no studies have examined the use of phenytoin to prevent corticosteroid-associated memory changes in humans. Mood changes are also common with corticosteroids, but few treatment data are available. This report examines whether phenytoin can prevent mood or declarative memory changes secondary to bursts of prescription corticosteroids. METHODS: Thirty-nine patients with allergies or pulmonary or rheumatologic illnesses and given systemic corticosteroid therapy were randomized to receive either phenytoin (300 mg/day) or placebo concurrently with the corticosteroids. Mood was assessed with the Hamilton Rating Scale for Depression, Young Mania Rating Scale, and Activation (ACT) subscale of the Internal State Scale; declarative memory was assessed with the Rey Auditory Verbal Learning Test (RAVLT) at baseline and after approximately 7 days of corticosteroid plus phenytoin or placebo therapy. RESULTS: The two groups were similar in age, gender, education, and corticosteroid dose. The phenytoin-treated group showed significantly smaller increases on the ACT, a mania self-report scale, than the placebo-treated group. Groups did not differ significantly on RAVLT change scores. CONCLUSIONS: This is the first placebo-controlled study to examine whether a medication can prevent mood and memory changes secondary to corticosteroids. Phenytoin blocked the hypomanic effects of prescription corticosteroids; however, phenytoin did not block the declarative memory effects of corticosteroids.

Adrenal Cortex Hormones↗

The decision-making process of US Food and Drug Administration advisory committees on switches from prescription to over-the-counter status: a comparative case study.

BACKGROUND: The US Food and Drug Administration (FDA) and FDA advisory committees have been under increasing scrutiny as a result of media attention to safety concerns. OBJECTIVE: This article compares the decision-making process of the FDA's Nonprescription Drugs Advisory Committee (NDAC) in 3 cases of a proposed switch from prescription to over-the-counter (OTC) status involving a nicotine replacement therapy product, 2 statins, and an emergency oral contraceptive. METHODS: This comparative case study reviewed written transcripts and slides from 4 NDAC committee meetings and a digital video disc recording of a later meeting held to reconsider one of the proposed switches. The focus was on the committee's discussion and deliberation processes. Content analysis and iterative coding were used to assess the level of participation by committee members and the extent to which committee discussion adhered to both the key draft list questions provided by the FDA and the published DeLap criteria for switches from prescription to OTC status. Other major themes and discussion topics were identified, and the voting process was analyzed. RESULTS: In the absence of clearly defined meeting procedures, the advisory committees developed their own procedural standards. There were major differences between meetings in terms of the extent of discussion of the key draft list questions and adherence to the DeLap principles, discussion of other themes and topics, and voting methods. In each case, at least 1 major topic of discussion was not directly related to safety, efficacy, or self-use. Additional identified themes were the public health significance of a switch to OTC status, costs, and access. CONCLUSIONS: Variability in processes created discrepancies in the decision-making criteria used by the NDAC committees. There is a need to establish structured procedures to achieve an optimal level of uniformity and transparency in advisory committee processes.

Advisory Committees↗

Compliance with refilling prescriptions for atypical antipsychotic agents and its association with the risks for hospitalization, suicide, and death in patients with schizophrenia in Quebec and Saskatchewan: a retrospective database study.

OBJECTIVE: The objective of this analysis was to describe the patterns of compliance with atypical antipsychotics among patients with schizophrenia in actual practice in 2 Canadian provinces and to examine the relation between degrees of compliance and the risks of hospitalization, suicide, and death. METHODS: Adults with a diagnosis of schizophrenia who filled at least 1 prescription for risperidone, olanzapine, or quetiapine were identified in the Quebec public prescription drug insurance plan database (from July 1, 2001, to December 31, 2004) and the Saskatchewan Health database (from January 1, 1999, to December 31, 2003). Compliance was assessed based on the medication possession ratio, which was estimated as the proportion of days for which medication was available over each month of follow-up (> or = 80% = good compliance; 50%-79% = moderate compliance; < 50% = poor compliance). The association between the early and long-term effects of compliance and the risks of hospitalization, suicide, and death were examined using Cox regression, with adjustment for baseline age, sex, and use of antidepressants, sedatives, and lithium (Quebec only). RESULTS: respective 41,754 and 3291 patients were identified from the Quebec and Saskatchewan databases. Approximately half of the patients in each cohort were male and were aged < 45 years. Many patients had good compliance over the full follow-up period (Quebec, 61%; Saskatchewan, 45%); however, poor compliance was seen in 23% of patients from Quebec and 34% of those from Saskatchewan. Compared with poor compliance, the long-term effect of good compliance was associated with a significantly decreased risk of all-cause hospitalization (Quebec: adjusted hazard ratio [HR] = 0.60; 95% CI, 0.57-0.64; Saskatchewan: adjusted HR = 0.81; 95% CI, 0.69-0.95) and psychosis-related hospitalization (Quebec: adjusted HR = 0.37; 95% Cl, 0.34-0.40; Saskatchewan: adjusted HR = 0.45; 95% CI, 0.32-0.64). The Quebec data also indicated a significant association between good versus poor compliance and a decreased risk of death (adjusted HR = 0.58; 95% CI, 0.51-0.66) and suicide (adjusted HR = 0.68; 95% CI, 0.55-0.84) that was not observed in Saskatchewan. CONCLUSION: In this retrospective analysis of patients with schizophrenia in Quebec and Saskatchewan, good compliance with atypical antipsychotic medications was associated with substantial reductions in the risk for all-cause and psychosis-related hospitalizations.

Adult↗