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How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.

It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated in this article, the reporting of ADRs via e-mail would cause real problems for the drug safety units. Finally, they consider that telephone call centres should be restricted to a specific communication problem such as crisis management or Dear Dr letters.

Adverse Drug Reaction Reporting Systems↗

The cancer information service research consortium: an emerging laboratory for cancer control research.

The Cancer Information Service (CIS) was established in 1975 by the National Cancer Institute (NCI) to provide accurate, up-to-date information about cancer to the nation. Although the CIS has in the past served as a venue for cancer communications research, up until very recently the research capacity of the CIS was underutilized. In 1993, this situation changed dramatically with funding from the NCI to form the Cancer Information Service Research Consortium (CISRC). In this article the CISRC is described for the first time, including its research agenda and administrative structure. Early indications from the CISRC suggest that the CIS can serve as one of the premiere laboratories in the country for cancer communications and cancer control research. Several factors are suggested for the early success of the CISRC in sustaining this collaborative effort with the CIS. The progress that has been made by the CISRC could provide a useful model for other large health information programs to maximize their contributions to behavioral science and health promotion research, as well as to establish their own program of policy-relevant research.

Community-Institutional Relations↗

Information technologies within the cancer information service: factors related to innovation adoption.

CONCLUSIONS: This collaborative study, conducted by members of the Cancer Information Service Research Consortium Team for Evaluation and Audit Methods and the Network Analysis Advisory Board, is part of a larger project that evaluates the impact of communication structure on innovation within the contractual network of the Cancer Information Service (CIS). This study examines four different technological innovations with respect to the characteristics of relative advantage, compatibility, observability, complexity, trialability, adaptability, riskiness, disadvantage, computer knowledge, and acceptance. METHODS: Data were gathered from self-report questionnaires completed in May 1995 by organizational members (n = 82) within the National Cancer Institute's CIS, a geographically dispersed federal government health information program. RESULTS: Paired comparison t tests found that organizational members rate contrasting dimensions of an innovation differentially, depending on the nature of the specific technology. For example, significantly lower levels of riskiness were reported for computerization for communication (e.g., e-mail) than for computerization for telephone service or outreach. In addition, computerization for office management had significantly lower levels of riskiness than computerization for telephone service or outreach. With respect to complexity, computerization for communication had significantly lower ratings than did outreach. In terms of observability and trialability, computerization for communication had significantly lower ratings than for telephone service. With respect to relative advantage, computerization for office management had significantly lower ratings than all other areas of computerization. In terms of computer knowledge, ratings were significantly higher for communication than for all other areas of computerization. No significant differences were found between contrasting innovations for adaptability or acceptance. CONCLUSIONS: Results suggest that organizational members rate contrasting dimensions of an innovation differentially, depending on the nature of the specific innovation. Managers can employ this information as a diagnostic tool to evaluate the fit of an innovation, anticipate problems arising as a result of innovation, and modify innovations to reflect the changes that stakeholders deem necessary. Computerization efforts such as this one are at the cutting edge of efforts to improve the dissemination of information to the public. These efforts can result in considerable improvements in public health.

Automation↗

Telephone counseling as adjuvant treatment for nicotine replacement therapy in a "real-world" setting.

BACKGROUND: Physicians prescribing nicotine replacement therapy (NRT), or health plans covering NRT, often want their patients to receive adjuvant behavioral treatment. However, how to do that in a "real world" is unclear. This paper reports results from a public health program that uses proactive telephone counseling as support for physician advice and provides adjuvant treatment for NRT users. METHODS: Participants were NRT users (N = 8,832) who called the California Smokers' Helpline, a statewide cessation service that provides proactive counseling, one session before NRT use and multisessions after the smokers received NRT. After receiving NRT, some participants discontinued the counseling while others continued with follow-up sessions. A subset of the 8,832 participants (n = 664) was interviewed 13 months later for quitting status. RESULTS: After receiving NRT, 79% of the participants continued with counseling and received 4.2 sessions on average, while 21% of them received only one session. Overall, 82.8% of all participants made a quit attempt. Nicotine patch users were more likely to make an attempt than nicotine gum users (85.2% vs 66.3%), but the relapse probability was the same for these attempts. Those who received multiple counseling were more likely to make an attempt than those receiving single counseling (84.4% vs 77.1%) and were more likely to stay quit for 1 year (25.6% vs 16.1%). CONCLUSIONS: Proactive telephone counseling is a promising adjuvant treatment for NRT users in a "real-world" setting: a convenient referral service for supporting health plans or physicians who advise their patients to quit smoking.

Adolescent↗

A collaborative model of a county crisis intervention team: the Lake County experience.

A model is introduced for the classification of crisis intervention and disaster services as being clinic-based, ad hoc, school-oriented, disaster service based and integrative. An example is presented of an integrative-collaborative model that was developed in Lake County, Ohio to cope with situations of suicide, accidental death or natural disaster when they occur in rural areas and small towns. The Community Crisis Intervention Team (CCIT) was developed with characteristics specific to a collaborative model. The distinctive qualities of the CCIT are identified and discussed within the context of a case study of a postvention in a school setting following adolescent suicide.

Community Mental Health Services↗

Developmental and gender differences in anonymous support-seeking: analysis of data from a community help line for children.

Calls to a community help line for children were analyzed for developmental and gender trends in support-seeking during middle childhood. Results indicated that between the ages of 10 and 11 the nature of help-seeking by callers changed, with a shift toward more informational support-seeking and concern regarding interpersonal problems. This shift was particularly dramatic for girls. Gender differences in the type of support sought (informational vs. instrumental) were slight. Parallels with other studies of stress and coping in children are drawn.

Affective Symptoms↗

Peer support telephone dyads for elderly women: was this the wrong intervention?

Tested a preventive intervention in which peer telephone dyads were developed for low-income, community-living, elderly women with low perceived social support. After an initial assessment, respondents were randomly assigned to either an assessment-only control or received 10 weeks of friendly staff telephone contact. After a second assessment, participants receiving the staff contact were randomly assigned to continue that contact or were paired in dyads to continue phone contact with one another. Dependent variables were measures of perceived social support, morale, depression, and loneliness. All groups, particularly the staff contact group, showed some improvement in mental health scores over time, but there were no significant differences between intervention groups, or between intervention and assessment-only control groups. The results suggest that participation in the study and in personal assessment interviews at home were probably morale enhancing, and that additional telephone contact did not significantly add to that effect. Evidence also indicates that, in this sample, low perceived family support was significantly related to poor mental health, so it is possible that a program designed to increase friend support may have been the wrong intervention.

Aged↗

Comments on Heller, Thompson, Trueba, Hogg, and Vlachos-Weber, "peer support telephone dyads for elderly women".

Comments on the support intervention study with elderly women by Heller et al. (1991). The study highlights the need to determine what aspects of social support are most effective for particular populations. I discuss what basic research on supportive functions suggests for this population, and what kinds of knowledge are needed to best translate epidemiologic findings into intervention research designs. Related research on the effects of family vs. peer support is discussed, and processes that may help or hinder family support are proposed. Finally, I note some implications for further research on social networks of elderly persons, and approaches to increasing social companionship and social integration.

Aged↗

Let's hang up and try again: lessons learned from a social support intervention.

A support intervention by Heller et al. (1991) sought to improve the well-being of elderly women by providing friendly telephone contact with staff or peers. The failure of this thoughtful and carefully implemented intervention serves to highlight the difficulty of designing support interventions. Several lessons are discussed regarding the complexity of the support process, the utility of different research strategies, the importance of specifying the targeted focal point in the support process, the need to state models explicitly, the choice of measures, and the implications of select participant samples.

Aged↗

Peer support telephone dyads for elderly women: the wrong intervention or the wrong research?

Reaction to the intervention paper by Heller et al. (1990) places their work into a larger framework of social support interventions to make explicit the assumptions underlying the project. It is suggested that the intervention was constrained by the experimental design of the evaluation research and overlooked important features in the process of relationship development among dyads. In developing interventions designed to impact personal relationships, it is recommended that community psychologists (a) consider the context in which personal relationships are formed, maintained, and terminated; (b) use the power of their scientific inquiry to create, strengthen, or legitimize new social roles for people who are disenfranchised; (c) promote the use and legitimacy of research methods that compliment rather than dictate the nature of interventions.

Aged↗

Fine-tuning theory to the needs of the world: responding to Heller et al.

Comments on the Heller et al. telephone intervention with isolated elderly women are presented. The importance of addressing contextual factors involved in assessments of social support in community samples is discussed. Comparisons are drawn between the assessment of social support among an elderly sample and an assessment of social support among a sample of chronic illness patients. Three key issues are discussed: (a) Is a little support better than no support and is a little all we really need? (b) Is family support more important than friend support, at least to this population? (c) Can long-term relationships be replaced?

Adaptation, Psychological↗

Facilitating friendship formation in late life: puzzles and challenges.

Considerable evidence indicates that friendships contribute to the psychological well-being of older adults. Seeking ways to help lonely older adults form new friendships thus makes a good deal of sense, but as the disappointing results reported by Heller et al. (1991) indicate, translating this conceptually sound goal into a practical reality presents many challenges. This commentary seeks to build upon the authors' analysis of factors that may have undermined the success of their intervention by discussing the social contexts that may be most conducive to friendship formation in late life and by considering whether kin ties represent a more viable focus of intervention efforts than do peer ties.

Aged↗

Peer telephone dyads: putting conclusions on hold.

Commentary on Heller et al.'s (1991) peer telephone intervention for elderly women addresses three issues: (a) the sources and kinds of information needed to inform decisions about the choice of intervention; (b) the criteria used to evaluate the process and outcomes of support interventions; (c) the social psychological dynamics stimulated by the intervention protocol and by the particular form of the intervention. The latter two issues complicate interpretation of the study's findings and raise additional questions about whether and why the intervention was unsuccessful.

Aged↗

Support interventions for older adults: confidante relationships, perceived family support, and meaningful role activity.

The rationale and problems encountered in implementing a peer-support telephone intervention are described. The research conducted by Heller, Thompson, Trueba, Hogg, and Vlachos-Weber (1991) was based on epidemiological literature documenting the moral enhancing value of confidante relationships. However, that literature may be insufficiently precise to form the basis for an intervention without prior ethnographic study of the local target population. Furthermore, the positive effects of peer friendships may refer to long established relationships rather than to newly formed social ties. It is concluded that future support intervention research with older adults should concentrate on reinforcing meaningful role activities, and that greater attention should be given to strengthening indigenous ties before attempting to create new ones. While prior process research and formative evaluation are of value, we also emphasize the importance of well-controlled field studies in the ultimate test of intervention hypotheses.

Aged↗

A new technique for handling sexually abusive calls to telephone crisis lines.

Sexually abusive calls interfere with the legitimate functions of crisis lines and have detrimental effects on crisis line workers. This paper describes a new approach to responding to such calls in a way that meets the needs of the crisis line and encourages callers to seek therapeutic treatment for their problem. The proposed response is based on principles of covert conditioning and Ericksonian suggestions. A script of the response is presented along with a description of the rationale and suggested precautions for use with callers.

Female↗

Suicide: a review of calls to an adolescent peer listening phone service.

Calls about suicide to a teen peer listening phone service over a period of 5 1/2 years are described. The majority of those calling about suicide were females. The phone contacts were of longer duration and later in the evening than calls about other concerns. Those concerned with suicide also discussed other serious issues such as self-esteem, family problems, substance use, and abuse and were less likely to be calling "just to talk."

Adolescent↗

Role and functions of Poisons Information Centre.

The Poisons Information Centre (PIC) is a specialized unit providing information on prevention, early diagnosis and treatment of poisoning and hazard management. Most of the developed and many developing countries have well established poison control centres with poisons information service, patient management facility and analytical laboratory. In India, the National Poisons Information Centre (NPIC) was established in February, 1995 in the Department of Pharmacology at the All India Institute of Medical Sciences, New Delhi. The centre provides toxicological information and advice on the management of poisoned patients adopted to the level of the enquirer. The basis of this service are the databases on poisoning, drug reactions and also the continuous and systematic collection of data from the library. This information service is available round the clock. The PIC has the training responsibility extending to medical and other health professionals and community. The NPIC organized two successive training courses for medical professionals and para professionals at all health levels. Further, NPIC is a participant of INTOX project of IPCS/WHO, receiving regular yearly training on the use of INTOX database. Laboratory service is an essential component of a poisons control programme, providing analytical services on emergency basis to help in diagnosis and management. The NPIC is developing facilities for quick diagnosis of poisoning cases. Toxicovigilance and prevention of poisoning is another major function of PIC. The Centre has prepared manuals and leaflets on prevention and management cards on treatment of various poisonings. Thus the Centre provides a service with considerable health benefits, reducing morbidity and mortality from poisoning and gives significant financial savings to the community.

Child↗