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Biomedical subjects

E Hemminki

Publications and source records attributed to E Hemminki.

At least 181 records · Page 10Linked to original sources
PubMed1981

Quality of reports of clinical trials submitted by the drug industry to the Finnish and Swedish control authorities.

The purpose of the present study was to investigate the quality of trials used in support of applications for licensing drugs. All applications for psychotropic drugs received by the Finnish and Swedish drug control authorities in the years 1965, 1970, 1974, and 1975 were studied. In addition, a random sample of applications for "other drugs" was selected in Finland. All reports of clinical trials on the therapeutic efficacy of the drugs were included. Many trials were uncontrolled, and in controlled trials major drawbacks in the quality of the trial design and in the accuracy of reporting were often found. The number of patients in each controlled trial was small, and the majority of trials concerned selected groups of patients. Measures of effectiveness were often such that it was impossible to establish the overall benefit of the drug. Treatment times were short. Adverse effects were handled separately and were not adequately combined with efficacy. When a decision about licensure of a drug is made, it is not enough to know that the drug affects body systems, but its therapeutic value should also be established. The trials attached to the applications for licensing did not usually do that.

Clinical Trials as Topic↗
PubMed1981

Noninvestigational use of unapproved drugs--experience from the Scandinavian countries.

In the Scandinavian countries it is possible to use unapproved drugs for treatment purposes with special permission from the drug control authorities (individual licenses). The Scandinavian practice and the problems connected with it are described. The basic principle underlying the laws and regulations has been and is the same in each country: unapproved drugs should be used only in exceptional cases for special reasons. However, the practice has become different: many individual licenses have been granted, giving physicians much greater opportunity to prescribe drugs of their choice than the apparently tight Scandinavian licensing laws and practices would suggest. The great number of individual licenses has become an administrative problem and has also undermined the principle underlying the law.

Drug Utilization↗
PubMed1981

Number and type of psychotropic drugs on the Scandinavian market in 1950-1977.

This article describes the number and types of psychotropic drugs on the market in Denmark, Finland, Norway, and Sweden from 1950-1977. The total number of drugs on the market in each country depended greatly on how psychotropic drugs were defined, but trends with time and differences between the countries were less affected by this definition. The number of drugs was highest in Finland and lowest in Norway. In all countries, the number of drugs increased from 1950 to the mid-1960s, most abruptly in Finland. They then quickly decreased in Finland and Sweden, but remained fairly constant in Denmark and Norway. The number of different active substances was much smaller than the number of drugs, and the differences between the countries were also smaller. The proportions of combination and hidden psychotropic drugs in relation to all psychotropics were considerable in Finland and Sweden, and the varying numbers of combination drugs contributed greatly to the wide differences in the number of drugs. From the medical point of view, far too many drugs were on the market in that period.

Drug Combinations↗
PubMed1981

Drug reimbursement in four Nordic countries.

The purpose of the present study was to describe the reimbursement systems in use for the reimbursement of medicaments purchased within the state compulsory health (sickness) insurance systems in four Nordic countries, and to study whether and how reimbursement for drug consumption. During the study period drug reimbursement has been selective in Denmark and Norway, but in Finland and Sweden it had been a mixture of selective (free drugs) and unselective (partially reimbursed drugs). The use of drug reimbursement as a control measure to regulate the quality and quantity of drug consumption has not been explicit. With the exception of monetary costs, the objectives of the control have not been explicitly stated, and administrative practices have sometimes been arbitrary. Even though at first sight the Finnish, Norwegian and Swedish systems of free medications may appear alike, a more detailed analysis of diseases and drugs showed tht the comprehensiveness and contents of the schemes differed. The differences seemed largely of an administrative nature. The financial costs of drug reimbursement had risen rapidly and varied from one country to another, being highest in Sweden.

Denmark↗
PubMed1981

Adverse reactions to antibiotic drugs: the present scope of the problem in outpatient care and possibilities for improvement.

This study provides estimates of the frequency of adverse reactions due to antibiotic therapy and the effectiveness of two approaches in reducing them. Calculations were made of the extent of decrease in adverse reactions if physicians prescribed the drug of choice, and if antibiotics were prescribed only when necessary. The risks of adverse reactions and the estimates of unnecessary prescribing were obtained from the published medical literature. The number of prescriptions and the diseases treated were obtained from a commercial data source (IMS America). It was estimated that on average one antibiotic prescription per inhabitant was prescribed in outpatient care, that 7.6 percent of the population had adverse reaction due to antibiotic therapy, and that 1.4 percent had a serious reaction in 1974 in the United States. If physicians had prescribed the drug of choice, the number of adverse reactions would have been reduced by 37 percent. If antibiotics had been prescribed only when necessary, but the pattern of prescribing different antibiotics had been the same, one third of the adverse reactions would have occurred. If physicians had prescribed the drug of choice and only when necessary, about one fifth of the adverse reactions would have occurred. The actual number of avoidable adverse reactions may be larger or smaller than these estimates, but the magnitude of the effect indicates an area for concern.

Anti-Bacterial Agents↗
PubMed1980

Study of information submitted by drug companies to licensing authorities.

Reports of clinical trials included in applications submitted by drug companies to licensing authorities in Finland and Sweden in four different years were studied. Many reports were submitted, but most of the trials were uncontrolled and of poor quality. Many of the reports were unpublished, and thus, as the submissions are secret, were not available to doctors. These unpublished reports were in most respects as valuable as the published reports. Most of the reports included some information about adverse effects; the information was often deficient, but skilled analysis might increase its value. This study provides support for those who want to see public disclosure of the reports of trials submitted in licensing applications.

Clinical Trials as Topic↗
PubMed1980

Spontaneous abortions by occupation and social class in Finland.

A hospital discharge registry covering all general hospitals in Finland was used in the study of spontaneous abortions. Spontaneous abortions were analysed by the women's occupation and socio-economic class for 1973-75 inclusive. The risk of spontaneous abortion increased from social class 1 to 4 by about 50%. The occupational groups with an increased frequency of spontaneous abortions included industrial and construction work, agriculture, forestry and fishing, sales, transport and communication, services, and students and trainees. Decreased frequency of spontaneous abortions was noted among housewives, and in managerial and clerical occupations. The results suggest that socio-economic factors contribute to the rate of spontaneous abortions analogous to their known adverse effects on pre-term birth, birth weight and perinatal mortality.

Abortion, Spontaneous↗
PubMed1978

Routine administration of iron and vitamins during pregnancy: review of controlled clinical trials.

The purpose of this review was to determine whether routine administration of iron and vitamins during pregnancy had beneficial effects on birth weight, length of gestation, infant morbidity and mortality, and maternal morbidity and mortality. We searched for controlled clinical trials done in developed Western countries and reported in English, German, Finnish, and Scandinavian languages. Seventeen trials were found. In one trial, women who received vitamin B6 developed less dental caries. In another trial women receiving several different minerals and vitamins ahd fewer deliveries before the 40th week and less pre-eclampsia. In a third study, women receiving polyvitamin concentrate had less pre-eclampsia. None of the studies reported and benefit for other outcomes.

Birth Weight↗
PubMed1978

Prevention and treatment of premature labour by drugs: review of controlled clinical trials.

This review sought evidence from 18 controlled clinical trials about the benefits of drugs (hormones, ethanol or beta-sympathomimetic agents) used to prevent premature birth. Of the 16 trials comparing drug with placebo, 13 were judged to be methodologically adequate. In eight trials, drugs were given prophylactically and in five they were given therapeutically. Two of the therapeutic trials found the drug more effective than placebo in postponing delivery. However, only one therapeutic trial and one prophylactic trial found the drug to affect favourably the outcome for the infant. The side effects of the drugs were not systematically studied. Additional clinical trials are needed to justify the use of drugs to inhibit labour.

Adrenergic beta-Agonists↗
PubMed1978

Frequency of psychotropic drug prescribing for children in Tampere, Finland.

The purpose of the present study was to determine the frequency with which psychotropic drugs are prescribed for children under 10 years of age in outpatient care in Finland. This frequency was estimated from the reimbursements paid by the Social Insurance Office of Tampere City in 1974. Every third psychotropic drug prescribed for children born in 1965-74 was included. This resulted in 319 children with 375 psychotropic drug prescriptions. About 4% of children under 10 years old in the Tampere area had received within one years's time one or more psychotropic drugs in outpatient care. About half of the psychotropic drugs were prescribed by general practitioners. Sedatives were the most frequently prescribed drugs, especially in the younger are groups. Antidepressants and antiepileptics were common in the older age groups. The most commonly specified indications were fever and restlessness.

Ambulatory Care↗
PubMed1978

Prevention of low birth weight and pre-term birth: literature review and suggestions for research policy.

Mortality during the first week of life has greatly decreased in developed countries, but the gains have been unevenly distributed across socioeconomic groups and geographic areas. Among many explanations for these differences, low birth weight is shown to be significant in the United States, Sweden, and Finland. An imbalance between potential benefits to be gained and the paucity of experiments reporting on this is noted.

Birth Rate↗
PubMed1977

Regional coffee consumption and mortality from ischemic heart disease in Finland.

In Finland the mortality from ischemic heart disease is highest in North Karelia and lowest in Southwest Finland. In this study the consumption of coffee has been measured from the total sales in the different areas of Finland to see if it correlates with the mortality from heart disease. North Karelia had higher coffee sales per inhabitant than Southwest Finland. This finding reinforces the view that carefully controlled dietary studies are needed to establish the role of coffee in the mortality from ischemic heart disease.

Adolescent↗
PubMed1977

Content analysis of drug-detailing by pharmaceutical representatives.

Drug detailing is important in drug prescribing. This report describes a study made on drug presentations to groups of doctors in Helsinki. The method was silent observation of presentations given by medical representatives. Analysis of the content of the presentations revealed that side-effects and contraindications were often neglected; the drug presented was always recommended as the drug of choice; other forms of treatment were seldom mentioned. References to Finnish doctors doing clinical trials with the drugs were often made. Even though this study was restricted, its results show that drug detailing and its significance in post-graduate education call for more attention.

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