bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of early signals of drug‐induced stevens‐johnson syndrome in the WHO ADR database
Authors: Li Dakui , Lindquist Marie , Edwards I. Ralph 
Published: October 2006

AbstractThe WHO database of the Collaborating Programme for International Drug Monitoring, which currently contains data from 31 countries, was reviewed for all drug/Stevens‐Johnson syndrome associations. The total number of such reports was 1707, involving 106 medicines with three or more reports per drug. From this, 22 previously unreported signals were found. The average delay from the first report to a stronger signal involving three reports was 4.4 years, delay usually being due to confounding by other medicines excluding some reports from being included in the signal. Reports from, on average, 2.8 countries were required to make a signal, and it is concluded that the international database allows for an expedient way of finding strong adverse drug reaction signals of rare events.
Age and the spontaneous reporting of adverse reactions in the United Kingdom
Authors: Mann R. D. , Rawlins M. D. , Fletcher P. , Wood S. M. 
Published: October 2006

AbstractA study designed to investigate the relationship between age, spontaneous ADR reporting rates, general practice prescription volumes and population sizes has shown that, in the UK, from age 15 years and above, greater numbers of prescriptions are issued for females than for males; the sex difference in prescribing rates is most marked in respect of women during their reproductive years. ADR reporting rates are also much affected by age and, in respect of all ADRs, are highest in the fifth and sixth decades but appear to decline thereafter. Reporting rates of serious ADRs show a similar, though less pronounced trend, and again appear to decline in the ninth decade.
Prescription of non‐steroidal anti‐inflammatory drugs for children: A survey of Quebec physicians
Authors: Blancquaert Ingeborg R. , Gray‐Donald Katherine , Spitzer Walter O. , Zvagulis Inta , Pless I. Barry 
Published: October 2006

AbstractAn essential step in the assessment of the relative benefits and risks of a drug's use is the monitoring of its actual utilization in specific populations. However, few studies have documented the extent to which non‐steroidal anti‐inflammatory drugs (NSAIDs) are prescribed for children. We surveyed a sample of 1448 Quebec physicians by mailed questionnaire to estimate approximately how often and for which indications NSAIDs, excluding ASA and acetaminophen, had been prescribed over the past year for children under 16 years of age. The sample included all pediatricians and rheumatologists in the province, and a stratified random sample of general practitioners. A response rate of 81.5 per cent was achieved. The proportion of physicians prescribing NSAIDs varied with speciality and clinical condition. The highest proportions were recorded for dysmenorrhea and juvenile rheumatoid arthritis, followed by tendinitis/bursitis, musculoskeletal trauma and recurrent headaches. Patterns of use were also explored for conditions such as osteochondroses, chronic or recurrent limb and back pain, tooth abscess, and patent ductus arteriosus. These data indicate that NSAIDs are prescribed for conditions for which they are not currently recommended in the pediatric population. Further research is thus required regarding the implications of their use for a wider range of conditions.
Pharmacoepidemiology using a UK database of primary care records
Authors: Hall Gillian 
Published: October 2006

AbstractA number of large data resources in North America have been used successfully in pharmacoepidemiology for several years. The need for a similar resource in the UK has been identified for some time, but its development has only been possible as a result of large‐scale computerization of primary care record‐keeping. Currently, VAMP provides the only resource of this kind in Europe. This data resource has been proved capable of providing valuable research information and, consequent to recent upheaval, has a stable financial future.
Non‐steroidal anti‐inflammatory drugs and upper gastrointestinal bleeding, a post‐marketing surveillance case‐control study
Authors: Nobili A. , Mosconi P. , Franzosi Maria G. , Tognoni G. 
Published: October 2006

AbstractA post‐marketing surveillance case‐control study was set up and applied in an Italian hospital network to quantify the risk of upper gastrointestinal bleeding (UGB) and exposure to non‐steroidal anti‐inflammatory drugs (NSAIDs). During the period of study 441 cases of UGB and 1323 controls were recruited. The odds ratios associated with NSAIDs use were estimated for intake occurring over two different periods of time prior to hospital admission (i.e. during the preceding week and month). A strong association emerged for aspirin intake, both in the week (ORMLR = 11.2; 95% CI 7.8–16.9) and in the month (ORMLR = 6.9; 95% CI 4.6–10.2) preceding hospital admission. A significant increase in the risk of UGB and use of diclofenac, naproxen and ibuprofen, and indomethacin was also found in the two exposure periods considered, while for piroxicam a significant association was only apparent in the analysis of 1‐month exposure. As expected, paracetamol and pyrazolone derivatives were not associated with UGB. This pilot experience has shown the feasibility of setting up a multicentre post‐marketing surveillance programme and of establishing a network for drug monitoring within the Italian National Health Service, capable of providing a thorough evaluation of the benefit/risk profile of drugs.
Safety of fluoxetine: Comparison with fluvoxamine
Authors: Price John , Waller Patrick , Wood Susan , MacKay Angus 
Published: October 2006

AbstractThis review examines data on the safety of two 5‐HT reuptake inhibitors, fluoxetine and fluvoxamine. A comparison of the spontaneous reports of suspected adverse reactions to each drug sent to the UK Committee on Safety of Medicines has been made. This does not reveal important differences in their safety profile.
Prescribing patterns for combinations of warfarin and potentially dangerous interacting drugs in a large general practice population
Authors: Johnson Z. , Dack P. 
Published: October 2006

AbstractThe objectives of this study were to find what proportion of patients in a large general practice population were prescribed warfarin during a 1‐month period and to determine what proportion were simultaneously prescribed potentially dangerous interacting drugs. Data from prescriptions issued by GPs for the month of January 1991 to the segment of the population of the Eastern Health Board area entitled to free medical care were linked with individual age and sex data. Age and sex‐specific prescription rates for warfarin were calculated and the frequency of prescribing interacting drugs was computed for warfarin‐treated patients. The subjects of the study were residents of the Eastern Health Board who are entitled to free health care‐333 621 persons in all. Results were as follows. The crude warfarin prescription rate was 3.9 per 1000 (95% Cl: 3.7–4.1) and the rate increased with age, especially for men aged 65–74 in whom it was 15.5 per 1000 (95% Cl: 13.4–17.5). Of 722 patients on warfarin for more than 1‐month, 31.6% (95% Cl: 28.2–35.0) were prescribed at least one interacting drug concurrently, and 5.7% (95% Cl: 4.1–7.6) were prescribed more than one interacting drug. Non‐steroidal anti‐inflammatory drugs, including aspirin, accounted for 35.9% of the interacting drugs. It is concluded that combinations of warfarin and potentially interacting drugs are relatively commonly prescribed in this large general practice population.
Rate of venereal disease goinfections in women with vaginal candidiasis: Michigan medicaid
Authors: Gable Carol Brignoli , Holzer Susan Sedory , Engelhart Luella , Sarma Syam , Smeltz Frank , Schroeder Donald A. , Friedman Rhonda B. 
Published: October 2006

AbstractThis study was designed to address a concern about the conversion of vaginal imidazoles from prescription only to over‐the‐counter OTC status. The Food and Drug Administration (FDA) was concerned that women may misdiagnose a venereal disease as candidiasis and delay effective medical therapy for the venereal disease by using the OTC product. We conducted an epidemiology study in Michigan Medicaid (1984) to determine the rate of venereal disease in women with vaginal candidiasis. The Medicaid population was selected because it was high‐risk markers for sexually transmitted diseases (STD) — low socioeconomic status and a high proportion of blacks. We used the medical and pharmaceutical claims of a 5% random sample of 98,020 women aged from 10 to 60 years with vaginal infections, who were continuously enroled in Medicaid and had no other known medical insurance. We defined a candidiasis episode as beginning with a diagnosis or prescription for candidiasis and followed by a 2 week study period. We excluded episodes with antibiotic therapy or venereal disease in the preceding 2 weeks. The study population included 2518 women with 3507 candidiasis episodes. We used a conservative approach in defining venereal disease to include Trichomonas, chancroid, gonorrhoea, herpes, syphilis, pelvic inflammatory disease (PID) and non‐specific or unidentified STD. These venereal diseases were identified by diagnosis, specific prescription medication or antibiotic therapy for the disease during the 2 week study period. The incidence rate of venereal coinfections was 15.3% and the prevalence rate was 17.0%, predominantly Trichomonas, non‐specific or unidentified STD and PID. The prevalence rate varied with age (10–19 years and 20–40 years) and race (white and black women) from 12.6 to 20.8%. These prevalence rates are probably an overestimate for the general United States population because of the high‐risk population in Michigan Medicaid and the conservative approach used to identify venereal disease. In 1990 after reviewing this study and clinical trial data, the FDA approved prescription vaginal candidiasis medications for OTC use.
Crisis management: The medical director's response
Authors: Fitzgerald J. D. 
Published: October 2006

AbstractThis paper discusses the incidence and type of adverse drug reactions in relationship to their impact on a pharmaceutical company. It emphasizes that managing such a crisis requires skills in organizational processes that are not normally needed in the daily operation of a commercial enterprise. The role of the medical director is defined as it relates to the management of such a crisis. The key processes of managing complex interdisciplinary groups, and the problem of re‐evaluating the risk/benefit profile of the drug in question, within a constrained time frame and with an inadequate database are described. The principles of crisis communication skills are outlined. A case is made for giving a higher priority to crisis prevention by adopting certain straightforward precautions.
Causality assessment of adverse drug reactions using decision support and informatics tools
Authors: Hoskins Richard E. , Mannino Salvatore 
Published: October 2006

AbstractInformatics information organizing techniques have been applied to the causality assessment of adverse drug reactions since the 1970s. There has not appeared an easily applied and accurate method. The problem has to do with low quality and poorly organized input information or the attempted application of methods that are too rigid for some problems and inapplicable for others. Potentially the best current method, based on Bayesian probability, is difficult to use because of low quality or quantity of information. This handicap requires extrapolations which tend to result in a form of numerical global introspection. We suggest that the problem might be approached by using a generalized decision support algorithm which can be used with many different decision methods and proper informatics support for the immediate environment of the assessor in drug safety. The decision support algorithm we apply is based on an analytical hierarchical process algorithm implemented in the software CRITERIUM©. We give as an example the application of the algorithm to a suspected adverse drug reaction, cholestatic jaundice, as a result of treatment by chloropromazine. However, to support any decision‐making method, the information and informatics environment around the decision‐maker must be planned and developed. A set of requirements that best reflect adverse drug reaction causality assessment needs is discussed.
EURO‐ADR: Pharmacovigilance and research. A European perspective
Authors: Rawlins M. D. , Fracchia G. N. , Rodriguez‐Farré E. 
Published: October 2006

AbstractThis document presents the views of an Expert Group convened by the European Commission on pharmacovigilance in the European Community. The recommendations of the Expert Group for the development of pharmacovigilance are also presented.
Pharmacoepidemiology of warfarin use and deep venous thrombosis
Authors: Kurata John H. , Parker Charles , Kantor‐Fish Sandra , Deamer Robert , Ebert Emily , Nogawa Aki 
Published: October 2006

AbstractThree Southern California hospitals from the Center for Studies in Family Medicine research network participated in a study of the characteristics of patients using warfarin and of patients hospitalized with deep venous thrombosis. Computerized hospital and pharmacy data bases were searched to identify warfarin users and patients with deep venous thrombosis who received care between July 1987 and July 1990. Information on patients was abstracted from medical records.Of 337 warfarin users identified, 50% were male and the mean age was 51.6 years. The most common indications for warfarin therapy were cardiovascular conditions (45.8%) and deep venous thrombosis (31.8%). Warfarin therapy was initiated in the hospital for most patients (82%). Sensitivity to warfarin, as measured by the mean dose‐adjusted prothrombin time ratio, was 0.30. Female gender (p < 0.001) and increasing age (p = 0.03) were associated with increased sensitivity to warfarin (higher mean dose‐adjusted prothrombin time ratio). Regression analysis indicated that certain groups were significantly more sensitive to warfarin: females more than males (p < 0.0005); patients of other race/ethnicity more than blacks, hispanics, and whites (p < 0.05).Among the 114 patients hospitalized for deep venous thrombosis, there were 134 hospitalizations and 98 patients had only one hospitalization. Fifty‐eight per cent of the patients were male; the mean age was 44.2 years. The mean dose‐adjusted prothrombin time ratio was 0.28 for hospitalized patients.
Auditing drug therapy by peer review — the German experience
Authors: von Ferber Liselotte 
Published: October 2006

AbstractIt is known that traditional lecturing hardly ever leads to improvement in either the quality or cost‐effectiveness of everyday prescribing.In order, therefore, to improve their prescribing behaviour a group of physicians met to assess their prescribing routine for the second quarter of 1989. These discussions highlighted prescribing problems and allowed the development of pharmacotherapy guidelines tailored to the treatment situation which presents in primary health care practice. The prescription audit and review process was repeated so that the first comparison was between 1989 and 1990 and the second between 1989 and 1991.The study group consisted of 11 primary health care physicians and two advisors — one with a background in pharmacotherapy and the other with experience of group dynamics. The group met six times a year for two years. In undertaking the evaluations and comparisons special attention was paid to those drug groups in which the prescribed quantities suggested the possibility of irrational prescribing.Thus, the following problem areas were discussed and evaluated:
Prescribing of drugs of which the efficacy is not proven (e.g. drugs to enhance blood flow).
Prescribing psychotiopic drugs in combination.
Unnecessary prescribing of effective drugs (e.g. benzodiazepines, and H2 antagonists)
Excessively frequent prescribing in the elderly.
The cost‐effectiveness and usefulness of the review group process was also assessed.
It was found that in the course of a quarter of a year the 11 physicians treated 12,800 patients. In the first year of review (1989/1990) they saved 1,152,000 DM taking the four quarters together. In the second year the savings amounted to 1,381,000 DM. These savings were mainly the result of reduced prescription frequency and it was noted that the prescribing of less expensive drugs had only a minor effect.
Effect of federally mandated education policies on prescribing of isotretinoin to women of childbearing age
Authors: Heckbert Susan R. , Mtshali Glaudine , Platt Richard 
Published: October 2006

AbstractWe evaluated the effect of federally mandated educational interventions designed to reduce prenatal exposures to isotretinoin. We determined the number of isotretinoin courses prescribed at a health maintenance organization to women aged 15 through 44 between March 1987 and February 1990, and the number that had pre‐treatment pregnancy testing.The number of courses initiated without pre‐treatment testing fell by 54%, from 3.6 to 1.7 courses per month after educational programs were in place (p < 0.01). This decrease was principally due to a decrease in prescribing from 1.1 to 0.6 courses per 1000 women‐years (p < 0.002), although testing also increased from 51% (54 of 105) to 58% (21 of 36) of courses. These overall changes resulted from two distinct patterns of responses by physicians. Physicians who initially tested in over 40% of, courses (aggregate testing, 71% of courses (50 of 70)) reduced their collective prescribing from 5.0 to 0.3 courses per month and maintained a stable testing rate. In contrast, physicians who initially tested in fewer than 10% of courses increased their collective prescribing from 2.3 to 3.0 courses per month, and also increased testing from 6% (two of 32) to 56% (15 of 27) of courses.
PEM report number 1. Nicardipine
Authors: Inman William , Kubota Kiyoshi , Wilton Lynda , Pearce Gillian 
Published: October 2006

AbstractPatients (10,910) who had been treated with nicardipine by 5952 general practitioners between November 1986 and May 1988 have been studied by Prescription–Event Monitoring (PEM) for a period of one year. The events recorded on green forms were compared with three other calcium antagonists. The most frequent daily dose was 60 mg (59%). Nitrates had been co‐prescribed for 31% of the patients, diuretics for 28% and beta‐blockers for 23%.The rates of events occurring during the first month of treatment with nicardipine were compared with the mean rates recorded during the second to sixth month of treatment with 32 other drugs, including amlodipine, isradipine and diltiazem. The comparison was restricted to those events which had been experienced by 10 or more patients during the first month of treatment (rates in excess of one per 1000). A ‘signal’ was noted when this rate exceeded the second to sixth month average rate by a factor of three or more. Strong signals were recorded for all the well known side‐effects of nicardipine which include flushing (the commonest side‐effect), palpitations, tachycardia, faintness, headache, dizziness and tremor.Acute rashes, which were identified as an adverse reaction in the diltiazem study, were not seen in excess with nicardipine and heart block, which had been a rare but an important effect of diltiazem, was seen in only two patients.Accepting the limitations of a study of roughly 10,000 patients, which would be virtually certain to detect any event with a true frequency greater than about one in 3000, we have found no serious problems during the course of this PEM study.
PEM report number 2. Terodiline
Authors: Inman William , Clarke Joan , Wilton Lynda , Pearce Gillian , Veldhuis Gerritt Jan 
Published: October 2006

AbstractPatients (12,457) who had been treated by general practitioners between November 1986 and September 1987 have been studied by Prescription‐Event Monitoring (PEM) for a period of one year. The events recorded on green forms were compared with those recorded in 14 other PEM studies. Nearly 5000 of the patients were aged 70 or more. The most frequent indications for terodiline were incontinence (43%) and frequency (18%). The most frequent daily dose was 25 mg (62%). NSAIDs had been coprescribed for 11% of the patients, tranquillizers for 10% and diuretics and analgesics each for 7%.The rates of events occurring during the first month of treatment with terodiline were compared with the mean rates recorded during the second to sixth month of treatment. This analysis was restricted to events experienced by more than one per 1000 patients during the first month of treatment. A ‘signal’ was noted when this rate exceeded the second to sixth month base‐rate by a factor of three or more or when the first‐month rate exceeded the pooled base‐rate for other drugs by a similar amount. All the well known side‐effects of terodiline were encountered. They included dizziness, blurring of vision, dry mouth, retention of urine and tremor. A number of other events were signalled, especially by the comparison with other unrelated drugs. Noteworthy were confusion, drowsiness and headache. Medical and surgical conditions such as urinary tract infection, bladder cancer or surgery to the genitourinary tract were also signalled in large numbers, but were clearly related to treatment with terodiline because they were part of the indications for its use.We studied certain groups of events with special regard to the patient's age and the dose of terodiline. Confusion was obviously related to old age but not to dose. Drowsiness, in contrast, was linked to high dosage, but not to age. Blurring of vision was very obviously related to high dose and was more likely to be complained of by patients under the age of 60 years. Tremor was no obviously correlated either with age or dose of terodiline. We have also investigated a possible relation between the calcium‐antagonist effect of terodiline and a number of cardiovascular events, including syncope, cerebrovascular accident and transient ischaemic attacks. These might have been responsible for some of the unusually large numbers of falls, fractures or other injuries noted in the terodiline series.The medical records of 1176 patients who had died were carefully studied and the cause of death was established in 94% of patients.We were able to quantitate the side‐effects listed in the data sheet for terodiline. Dizziness, dry mouth, constipation, visual disturbances and retention all occurred during the first month with a frequency up to 10 per 1000 patients. Nausea, cited as a rare event, occurred in 8.5 per 1000. PEM detected a number of other unlisted events as likely to be causally related including drowsiness, confusion and headache.