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Providing drug information to health professionals and consumers: role and responsibility of the pharmaceutical manufacturer.

There is no law requiring any pharmaceutical firm to maintain a drug information center for their products. The package insert that accompanies the product is all that is legally mandated. Roche and other drug manufacturers provide these services because they believe it is in their own best interest and that of the users of their products to do so. Pharmacists are currently involved in providing drug information in numerous settings, particularly health sciences schools, hospitals, colleges, federal agencies and associations, as well as corporations. To date, they have been frequent users of company drug information services. It is hoped this discussion will stimulate anyone in need of product information to contact the manufacturer. They have the most complete data available on their products and are generally willing to share their information with other drug information services, practitioners and, in a more limited way, consumers.

Drug Industry↗

The UMLS project: making the conceptual connection between users and the information they need.

Conceptual connections between users and information sources depend on an accurate representation of the content of available information sources, an accurate representation of specific user information needs, and the ability to match the two. Establishing such connections is a principal function of medical librarians. The goal of the National Library of Medicine's Unified Medical Language System (UMLS) project is to facilitate the development of conceptual connections between users and relevant machine-readable information. The UMLS model involves a combination of three centrally developed Knowledge Sources (a Metathesaurus, a Semantic Network, and an Information Sources Map) and a variety of smart interface programs that make use of these Knowledge Sources to help users in different environments find machine-readable information relevant to their particular practice or research problems. The third experimental edition of the UMLS Knowledge Sources was issued in the fall of 1992. Current priorities for the UMLS project include developing applications that make use of the Knowledge Sources and using feedback from these applications to guide ongoing enhancement and expansion of the Knowledge Sources. Medical librarians are involved heavily in the direction of the UMLS project, in the development of the Knowledge Sources, and in their experimental application. The involvement of librarians in reviewing, testing, and providing feedback on UMLS products will increase the likelihood that the UMLS project will achieve its goal of improving access to machine-readable biomedical information.

Grateful Med↗

Perceptual structure of the desired functionality of internet-based health information systems.

With the emergence of the Internet, new health information systems are being designed and implemented that focus on coordination between providers, patients, payors and other constituents. While the importance of end user input in identifying the desired functionality of systems has long been recognized, very little work focuses on how users perceive the desired functionalities of these new systems to group together, and the implications of these groupings for the organization of functionalities into program modules and associated user interfaces. In this paper, we advance the construct, user based perceptual structure of desired functionality, in the context of these new coordination-intensive health information systems. Perceptual structure depicts how users perceive different desired system functions to group together. A conceptual framework is advanced which links perceptual structure to two broad categories of components, external coordination and internal coordination, which are related to prospective beliefs about system value. The framework is tested empirically via two field studies conducted by a hospital chain focusing on two major user groups, physicians and office administrators. The setting involves a proposed Internet-based health information system that links various constituencies in the service delivery chain. The empirically generated perceptual structure is found to be largely supportive of its conceptual counterpart. Implications for the design and development of this new class of systems, and public policy implications of such new systems are presented.

Consumer Behavior↗

Extracurricular activities: are they an effective strategy against drug consumption?

This work describes data obtained among 16,117 high-school students in fifteen Brazilian cities, involving participation in a number of extracurricular activities and consumption of drugs and alcohol. In the great majority of cases, no association was found between attendance of artistic-, community-, or sports-related activities and the use of these substances. On the other hand, a weak but constant negative association was found involving alcohol/drug consumption and attendance of religious activities. The authors discuss these findings in the light of some current preconceptions prevailing in Brazilian society: namely, that such activities constitute effective strategies for drug use prevention and the "idle" young persons tend to be potential drug users. They also discuss the implications that among students involved in religious activities drug and alcohol consumption was shown to become slightly lower.

Adolescent↗

Forfeiture of the profits and proceeds of drug crimes.

Drug trafficking is controlled by well-organized international criminal syndicates, whose only motives for becoming involved are to make profits and secure influence, which in turn help perpetuate illicit drug distribution networks. For example, one producer of illicit opium receives approximately $Can 650 for 10 kilograms of opium, from which one kilogram of heroin is produced and sold to end-users for up to $Can 12 million. The risks involved for those at the highest level of international criminal syndicates is extremely low since they are financiers who may never come in direct contact with illicit drugs or the law enforcement authorities. The proceeds of drug crimes are laundered through sophisticated international transactions often covered by legitimate operations. Current legislative provisions at both national and international levels are inadequate to support effective action to trace, freeze, seize and secure the forfeiture of the proceeds of crimes and to prosecute individuals who knowingly possess such proceeds. In pursuance of recent resolutions of the Commission on Narcotic Drugs, the Division of Narcotic Drugs of the United Nations Secretariat convened two expert group meetings, one in 1983 and the other in 1984, to consider ways and means of dealing with this problem. The meetings recommended the establishment of machinery that would facilitate, at both national and international levels, concerted action to deprive drug traffickers of the proceeds of their crimes. The annex to this article contains provisions recommended by the second expert group meeting for inclusion in an international instrument to supplement existing provisions of the international drug control treaties in order to deal more effectively with the profits of drug crimes.

Crime↗

HIV drug resistance and HIV transmission risk behaviors among active injection drug users.

HIV(+) injection drug users in clinical care may harbor and transmit drug-resistant HIV. We performed a retrospective study of HIV drug resistance and risk behavior among HIV(+) injection drug users in care to determine the number of needle-sharing events that involved and the proportion of sharing partners exposed to drug-resistant HIV. Among 180 HIV injection drug users, 55 (31%) reported injecting drugs in the previous month, and 22 of these (40%) shared needles and/or works 148 times with 296 partners, of whom 271 (92%) were thought to be HIV(-) or status unknown. Further, 55 (31%) drug users harbored resistant HIV, including 5 (3% of total) who also shared needles and/or works a total of 27 times with 44 partners (18% of all sharing events and 15% of all exposed partners). A small proportion of injection drug users receiving clinical care engage in injection risk behavior and carry resistant HIV; however, because of multiple partners and needle-sharing events, they expose a substantial number of individuals to drug-resistant HIV. Strategies to reduce injection drug use risk behaviors among patients in clinical care are needed to reduce the transmission of sensitive and resistant HIV.

Anti-HIV Agents↗

Factors contributing to self-reported drug use among London undergraduates 1971-72.

A questionnaire study of drug taking by 1113 London University undergraduates has been undertaken. This paper sets out to relate drug taking to student life. The variables which discriminate those who have tried illicit drugs from those who have not are conceptualised as representing alienation from study, distance from authority, and separation from parents. These variables are consistent with a general factor best labelled "non-conformity". The variables which seem to discriminate between degrees of involvement in psychoactive substances are ease of obtaining cannabis, estimated percentage of friends who use drugs, use of tobacco, seeing someone inject themselves, operational use of substances (i.e. use for purposes other than recreation or pleasure), and choice of future career. These variables represent four overlapping factors which affect involvement with psychoactive substances: contact with drugs, contact with drug users, identification with the user class, and within-class deviance. While non-conformity appears to be the factor in student life predisposing students to try illicit drugs, the factors which affect the degree of involvement with such substances seem relatively independent of student status.

Adult↗

Conspicuous consumption: characterizing high users of physician services in one Canadian province.

OBJECTIVES: To examine medical care use and costs, patterns of morbidity and co-morbidity, and other patient characteristics of high users of physician services in British Columbia. METHODS: This population-based study uses physician claims, hospital discharge summaries and vital statistics data linked at the level of the individual to compare characteristics of high users, other users and non-users of physician services in the Province of British Columbia, Canada. The study included all enrolled adults in the universal health care plan during fiscal year 1996/97. High users were defined as the most costly 5% of users of fee-reimbursed services. Key variables included age, sex, an ecological socio-economic status indicator and a comprehensive set of morbidity indicators, derived from the diagnoses recorded on the utilization records. RESULTS: The top 5% of users consumed a disproportionate 30% of spending on physician services. High users were overwhelmingly characterized by a significant burden of morbidity. Over 80% had at least six different types of morbidity during the study year compared with fewer than 20% of other users. High users were also much more likely to have major diagnoses that were both acute and chronic in nature. Co-morbidity involving psychosocial and chronic medical conditions was also very common. CONCLUSIONS: High users of physician services are overwhelmingly characterized by multiple and complex health problems. Policy tools based on a philosophy of deterrence such as cost-sharing are unlikely to have much impact on their costs and will likely do considerable harm.

Adolescent↗

An investigation of the applicability of the inventory, satisfaction with amplification in daily life, at 2 weeks post hearing aid fitting.

OBJECTIVE: To investigate the applicability of the self-report inventory, Satisfaction with Amplification in Daily Life (SADL), at 2 wk postfitting. DESIGN: The SADL was completed by two groups of hearing aid users, one fitted 2 wk before completion, the other at least 1 yr before. All SADLs were completed as a paper and pencil exercise, without involvement of an audiologist or other clinic staff. All the aid users were Government funded, all were fitted with the same model hearing aid, all were over the age of 60 yr, and all were fitted and counselled by the same two audiologists. Comparisons were made of the two groups' scores on each subscale and Global score, as well as on scores for each individual question. RESULTS: All scores for subscales, Global score, and individual questions were higher at 2 wk postfitting than at 1 yr. Significant differences were found for subscales Positive Effect (p < 0.05), Service and Cost (p < 0.025), Negative Features (p < 0.001), as well as for the Global score (p < 0.001). The only subscale not resulting in a significant difference was Personal Image (p > 0.10). It was noted that Negative Features, such as background interference, acoustic feedback, and problems with telephone use, apparently take longer to be observed than Positive Effects such as improved communication and good sound quality. By contrast with some other reported studies, these results all display a reduction in self-reported outcome, rather than stability, or even improvement, over time. Among other possibilities, this finding may suggest the SADL measures something different to that measured by other inventories. CONCLUSIONS: The results of this investigation suggest that, if the aim is to predict long-term satisfaction with aid fitting, 2 wk postfitting is too early for meaningful application of the SADL as an outcome measure. It is possible that an earlier stability in SADL scores might be obtained by inclusion of additional questions aimed at earlier detection of negative features. Such inclusions may detract from one of the SADL's advantages, namely its brevity. It also is suggested that the long-term value of self-report methods will depend on development of rigorous and scientifically acceptable administration procedures, including appropriate times for application.

Aged↗

[Syphilis in addicted pregnant women: better care through more awareness and contract between organizations involved].

Three women, aged 21, 20 and 30 years, were cocaine users and pregnant. There had been no prenatal monitoring until they reported with uterine contractions. Blood of the first two women was then tested; serology revealed active syphilis infections: their children had died in utero. The blood of the third woman had been tested as part of a street project; it revealed an active syphilitic infection but she could not be found for treatment. After delivery, the child showed withdrawal symptoms. The first and third women and the child of the third woman were treated with benzylpenicillin. The system for screening and treating drug-addicted pregnant women should be intensified.

Adult↗

A consultation leaflet to improve an older patient's involvement in general practice care: a randomized trial.

OBJECTIVE: To evaluate the effects of a programme to enhance the involvement of older patients in their consultations in general practice. DESIGN: Cluster randomized trial, in which data was collected from different cohorts. SETTING AND PARTICIPANTS: Twenty-five general practices in the south-east part of the Netherlands and their patients aged 70 years and over. INTERVENTION: Patients in the intervention group received a leaflet to help them prepare for the consultation. General practitioners (GPs) received an outreach visit to optimize older patients' involvement when visiting their GP. Patients in the control group received usual care. MAIN OUTCOME MEASURES: Questionnaires measuring involvement (COMRADE), enablement (Patient Enablement Index) and satisfaction with their care (EUROPEP). RESULTS: Pre-intervention 315 patients and post-intervention 263 patients were included. Subjects were satisfied with their involvement and the GP's behaviour during the consultation. No differences in effect as a result of the leaflet on involvement, enablement or satisfaction were found between the intervention and the control group. Of 318 patients who received the leaflet and visited their GP in the intervention period, 47 patients used the leaflet. These users were more accustomed to prepare themselves for consultations. Users reported more psychological problems than non-users. CONCLUSIONS: No relevant effects of the implementation programme on involvement, enablement or satisfaction were found. Other strategies are needed to enhance involvement of older patients in their care. Alternatively, older patients may perceive themselves sufficiently involved.

Aged↗

Influence of smokeless tobacco exposure on detoxification status and chromosomal damage in male and female habitues.

In India, a large number of tobacco chewers and masheri users are chronically exposed to tobacco genotoxicants. Detoxification processes involving cellular glutathione (GSH) and glutathione S-transferases (GST) determine the outcome of exposure to environmental mutagens including those present in tobacco. Hence, in this study, GSH levels, GST activity, GSTM1 genotype and cytogenetic damage were determined using lymphocytes from 114 smokeless tobacco habitues and controls. The study groups comprised of male tobacco chewers, female masheri users, and age- and sex-matched controls. Irrespective of the tobacco habit, GSH levels and GST activity were higher in females than in males. In both the groups of habitues, GSH levels were similar to those in controls, while a significant reduction in GST activity was observed in tobacco chewers only. The frequency of cytogenetic alterations was significantly elevated in both the groups of habitues with respect to controls. However, break-type aberrations were more frequent in tobacco chewers while gaps were commonly observed in masheri users. Differences in the nature of chromosomal alterations in the two groups of habitues appeared to be related to variation in total tobacco exposure and gender-related differences in the efficacy of the GSH/GST detoxification system.

Case-Control Studies↗

Direct comparison of time to AIDS and infectious disease death between HIV seroconverter injection drug users in Italy and the United States: results from the ALIVE and ISS studies. AIDS Link to Intravenous Experiences. Italian Seroconversion Study.

OBJECTIVE: To compare the rate of HIV disease progression in a sample of polydrug injectors (AIDS Link to Intravenous Experiences [ALIVE] study) with that in a sample of predominantly opiate injectors (Italian Seroconversion Study [ISS]). DESIGN: Prospective cohort studies of HIV-positive individuals whose date of seroconversion (SC) is known with a good degree of precision. The ALIVE study involves a community-based cohort of injection drug users (IDU) in the United States and the ISS reports on a clinic-based cohort of seroconverters in Italy with different exposure modalities to HIV. METHODS: Data from the two cohorts were combined. The date of SC was estimated as the midpoint in time between the last negative and the first positive HIV test. Time-to-event (i.e., AIDS or death from an infectious disease) statistical methods were used. Relative hazards (RH) of progression to event were adjusted by age at SC, gender, and year of SC. RESULTS: Of the 1003 IDUs (251 from ALIVE and 752 from ISS), 226 progressed to AIDS, and 146 died after AIDS or from an infectious disease; of these, 10 were without an AIDS diagnosis. The two groups of IDUs differed in terms of age at SC (median, 35 years for ALIVE and 25 years for ISS), proportion of women (24% versus 31%), race (7.6% versus 100% white), and year of seroconversion (i.e., ISS participants seroconverted, on average, earlier than ALIVE participants). Although the univariate analysis suggested possible differences for progression to AIDS, or to death from infectious disease between cohorts, multivariate analyses that adjusted for age showed no significant differences by cohort, gender, race, or time of seroconversion. The median time to AIDS for 25-year-old persons was 12.3 years for ALIVE and 11.8 years for ISS; for 35-year-old persons, it was 8.5 and 8.2 years, respectively. These estimates were similar to those for non-IDUs observed in the ISS and to those from large cohort of homosexual men. CONCLUSION: Our results confirm the importance of accounting for age when considering the incubation period for HIV infection. Despite differences in drug use characteristics, the similar median times to AIDS, for each age, between the two cohorts of IDUs and between the IDUs and the non-IDUs suggest a negligible effect of injection drug use on HIV progression.

Acquired Immunodeficiency Syndrome↗

Interprofessional collaboration with service users in the development of cancer services: the Cancer Partnership Project.

Patient and Public Involvement (PPI) is a cornerstone of UK National Health Service (NHS) policy. The Cancer Partnership Project (CPP) is the leading national PPI initiative in cancer care. The CPP espouses a "partnership" model, with a "Partnership Group" - collaborative service improvement groups formed of NHS staff and service users - in each of 34 cancer networks in England. These groups aim to enable service users to influence local cancer service development and thereby improve the effectiveness of services. We interviewed 59 cancer service users and NHS staff in a reflective evaluation of CPP. Groups were active and visible in 30 networks, their main activities being: providing an accessible source of consumer opinion; prolific networking and representation; patient information and communication projects; and lobbying for service improvements. The groups exhibited some significant tensions. The motivations of professional staff varied markedly, and "obligatory" involvement as part of a person's job was counter-productive when not coupled with a "personal" belief in the value of PPI. Other controversial areas were the disclosure by patients' of personal health and treatment experiences, and emotional attachment to the group. It was concluded that partnership groups represent a useful PPI model, but more attention generally should be paid to the complexities of PPI and timescales required for meaningful cultural change.

Adult↗

Prevalence of hepatitis A among drug users in north-eastern Italy. Is vaccination necessary in low prevalence areas?

BACKGROUND: The authors report on the prevalence of, and risk factors for, hepatitis A virus (HAV) in a group of drug users in Italy. METHODS: 404 heroin users were recruited and compared with a control group of 107 subjects in the general population. RESULTS: Drug users born in north-eastern Italy have a prevalence of anti-HAV similar to the control group. A much higher prevalence was found in drug users born in southern Italy. CONCLUSION: The similar prevalence of anti-HAV in drug users born in north-eastern Italy and in the general population, suggests that their lifestyle does not involve a substantial additional risk of HAV. The much higher prevalence found in drug users born in southern Italy is more likely to be related to infection during infancy.

Adult↗

Hepatotoxicity of antiretrovirals: incidence, mechanisms and management.

Hepatotoxicity is a relevant adverse effect derived from the use of antiretrovirals that may increase the morbidity and mortality among treated HIV-infected patients and challenges the treatment of HIV infection. Although several antiretrovirals have been reported to cause fatal acute hepatitis, they most often cause an asymptomatic elevation of transaminase levels. In addition to ruling out a variety of processes not related to the use of antiretrovirals or to the HIV infection, for appropriate management of the complication it is necessary to deduce the possible pathogenic mechanisms of the hepatotoxicity. Among these mechanisms, direct drug toxicity, immune reconstitution in the presence of hepatitis C virus (HCV) and/or hepatitis B virus (HBV) co-infections, hypersensitivity reactions with liver involvement and mitochondrial toxicity play a major role, although several other pathogenic pathways may be involved. Liver toxicity is more frequent among subjects with chronic HCV and/or HCB co-infections and alcohol users. Complex immune changes that alter the response against hepatitis virus antigens might be involved in the elevation of transaminase levels after suppression of the HIV replication by highly active antiretroviral therapy (HAART) in patients co-infected with HCV/HBV. The contribution of each particular drug to the development of hepatotoxicity in a HAART regimen is difficult to determine. The incidence of liver toxicity is not well known for most of the antiretrovirals. Although it is most often mild, fatal cases of acute hepatitis linked to the use of HAART have been reported across all families of antiretrovirals. Acute hepatitis is related to hypersensitivity reactions in the case of non-nucleosides and to mitochondrial toxicity in the case of nucleoside analogues. Alcohol intake and use of other drugs are other co-factors that increase the incidence of transaminase level elevation among HIV-infected patients. The management of liver toxicity is based mainly on its clinical impact, severity and pathogenic mechanism. Although low-grade HAART-related hepatotoxicity most often spontaneously resolves, severe grades may require discontinuation of the antiretrovirals, for example when there is liver decompensation, hypersensitivity reaction or lactic acidosis.

Alcohol Drinking↗

A comparison of health information on Florida's free-nets.

In the popular rush to provide electronic consumer health information, particularly via the Internet, one system has been largely overlooked-the free-net. Free-nets are often text-based systems from which users choose topics from "menus." While the World Wide Web can be more graphically appealing, it can also be overwhelming. Medical information resources are available to diverse populations through free-nets, which are convenient, free services. The amount of information and range of topics they offer are vast. A study of Florida's free-nets during a six-month period involved five free-net systems. Survey items included user demographics, interlibrary loan services, attitudes toward providing medical advice, and availability of medical librarian expertise. Comparisons include the number of user queries on medical and health-related free-net menus, user-friendliness, and the type of health information provided.

Computer Communication Networks↗

[Can court injunctions guarantee access to medicines in the public sector? The experience in the State of Rio de Janeiro, Brazil].

There are increasing numbers of legal suits concerning access to medicines brought against the Rio de Janeiro State Health Department. The situation indicated the need for a study to clarify the underlying issues. A sample of 389 court suits from January 1991 to December 2001 (stratified by year) was used. A cross-sectional design was used to describe and analyze the legal suits in relation to the responsibilities defined under the Unified National Health System (SUS). Results suggest major delays in court decisions. Most suits are filed by the Public Defender's Office for users of the National Health System. The most frequent cases involve medicines for the cardiovascular and nervous systems, many of which involve continuous use. Prescribing practices are institutionalized through the inclusion of the most frequently prescribed drugs in public financing lists, which makes rational drug use difficult to achieve. Municipalities are not fulfilling their responsibility to supply medicines to users, and the State is thus encumbered with these responsibilities. However, the State does not adequately supply medicines to the municipalities. The apparent lack of awareness among both lawyers and clients generates stress between the Executive and Judiciary branches and limits the resources for collective pharmaceutical services.

Brazil↗