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PubMed1997

Clinical pharmacology and therapeutics--past, present and future.

AIMS: To obtain information about the speciality of clinical pharmacology and therapeutics in the United Kingdom. METHODS: A survey of the views of 26 individuals in academic posts in clinical pharmacology and therapeutics was carried out by postal questionnaire. Response rate was 100%. RESULTS: Of 25 assessable responses of 25 centres, there were 35 academic staff of professorial status (median 2, range 0-5) and 61 staff of reader/senior lecturer status (median 2, range 0-5) but only 20 clinical staff in training grades in 19 institutions. All had extensive clinical commitments. Two-thirds of respondents considered that the speciality was stable locally and nationally. However, recruitment of trainees was poor with only 8% of responders having several good applicants for each post and 90% reported that recruitment had deteriorated in the last 5-10 years. Likely good future careers for clinical pharmacologists in training were considered by 75-80% of respondents to likely lie in the pharmaceutical industry or regulatory authorities. Greater flexibility is required to facilitate training in clinical pharmacology and therapeutics. CONCLUSIONS: Clinical pharmacology and therapeutics in the United Kingdom has a strong academic base but a sub-optimal age structure. Recent experience in recruitment into training posts was disappointing. This may reflect wider problems of recruitment into academic medicine in this country.

Forecasting↗
PubMed1986

From coercion to collaboration: two weeks in the life of a therapeutic community.

The purpose of this paper is to describe an aspect of the functioning of a therapeutic community conceptualized in terms of a sociotherapy framework as adumbrated, for example, by Edelson (1970), Rapoport (1960), and White et al. (1964). This approach, as distinct from group therapy, is concerned with the social system and social conditions that form the fabric of any given behavior. In the hospital context it is the therapeutic community that provides the fabric in which interpersonal and intergroup tensions can be addressed and clarified. We will illustrate this approach by detailing a discussion between therapy and nursing staff members who consult to, and participate in, the various group meetings of the Therapeutic Community Program (TCP), which together provide the framework of this particular community. Specifically, the discussion was about the evolving nature of the engagement between the community and a borderline patient, who attempted to alter the structure and functioning of an aspect of the community program in order to meet her own needs and avoid inner conflict. The discussion will focus on the way in which the community members adhered to existing structures and functioning, and were able to utilize staff consultation to this end, despite the patient's strong pressure on them to alter it. In describing this particular case we hope to illustrate how a well-functioning therapeutic community can "hold" one of its members in a manner that allows change to take place, and also serves as an important adjunct and facilitator to individual therapy.

Adult↗
PubMed1990

Coping with institutional life at the old people's therapeutic community.

A research project at a Finnish old people's home was carried out in 1983-1989, its aim being to explore whether therapeutic community principles can be applied to the institutional care of the elderly. Some aged seemed to adapt better to the community than others. In 1987 the group "excellent coping in institution" (N = 14) was formulated for this study, on the basis of favorable outcome, good adaptation to aging, nonproblematic behavior and a high subjective satisfaction with life. Using logistic regression analysis, the properties of this group were compared with the group "problem coping in institution" (N = 32). The following variables discriminated the excellent coping group best: therapeutic community activity, current mental health, and a socio-economically deprived childhood. This result suggested that active and mentally strong elderly coped better with the "homelike" therapeutic community method executed between 1983-87, which focused only on a pleasant atmosphere in which the old people could live together. Therefore the treatment policy has been partially reorganized since 1987, so as to include special attention for passive and mentally fragile residents. The modified therapeutic community that was developed seems to help coping in geriatric institutions if its working methods permit 1) active participation, 2) passive rest and reminiscence, and 3) support, holding, and even psychiatric intervention.

Adaptation, Psychological↗
PubMedDate not supplied

Risk assessment and therapeutic indices of artesunate and artelinate in Plasmodium berghei-infected and uninfected rats.

Artesunate (AS) is being developed as a potential agent for the treatment of severe and complicated malaria. A risk assessment of the therapeutic index and related hematological changes of AS and artelinate (AL) following daily intravenous injection for 3 days was conducted in Plasmodium berghei-infected and uninfected rats. The minimum doses of AS and AL for parasitemia suppression were 2.3 and 2.5 mg/kg, respectively, and the suppressive doses for half parasitemia (SD50) were 7.4 and 8.6 mg/kg, respectively. The maximum tolerated dose (MTD) for AS was 240 mg/kg with a therapeutic index of 32.6. The MTD for AL was 80 mg/kg with a therapeutic index of 9.3. Hematological changes were studied on days 1 and 8 after the final dosing. In both AS- and AL-treated rats, dose-dependent and rapidly reversible hematological changes (significant reductions in RBC, HCT, Hb, and reticulocyte levels) were seen in the peripheral blood. Bone marrow evaluation revealed a statistically significant reduction in the myeloid/erythroid ratio only at the highest dose of AS (240 mg/kg), albeit still within the normal ratio range (1.0-1.5:1.0). Looking at the respective therapeutic indices the authors have concluded that AS is much safer than AL. Both drugs induced hematological changes in rats that parallel the dose-dependent, reversible anemia and reticulocytopenia previously reported in animals and humans. However, no significant bone marrow depression was seen for either agent.

Anemia↗
PubMedDate not supplied

The experience of Therapeutic Touch in the lives of five postpartum women.

PURPOSE: To examine the experience of therapeutic touch in the lives of postpartum women. METHODS: Qualitative study of five postpartum women who participated in therapeutic touch for 2 months during home visits that focused on postpartum issues and concerns. The visits were audiotaped and transcribed. Data were coded and classified; linkages between categories were sought. RESULTS: Five themes or essences of the experience emerged: Feeling Relaxed, Feeling Open, Feeling Cared For, Feeling Connected, and Feeling Skeptical. CLINICAL IMPLICATIONS: The women and the researcher experienced many positive emotions during the home visits. Although it is unknown whether it was the visit, the interaction, or the therapeutic touch that helped the women feel cared for, the experience of participating in therapeutic touch seemed to add a dimension of mutual caring that added a special and unique quality to the home visit.

Adult↗
PubMed1996

Drug and Therapeutics Committees in Australia: expected and actual performance.

1. This study describes stakeholders' opinions on Drug and Therapeutics Committees (DTCs) and measures the composition, activities and perceived effectiveness of DTCs in Australia. 2. Focus groups explored the opinions of clinicians, consumers and administrators on the goals, objectives and strategies of DTCs. 3. A national survey was sent to 306 hospitals to collect data on the composition, committee processes, goals, objectives, educational activities, policies and decision making of DTCs. 4. Stakeholders believed the DTC should optimise therapeutic health outcomes for patients and economic outcomes for the hospital. Important objectives were availability of safe, efficacious and cost-effective medicines, affordability of medicines and quality use of medicines. 5. The national survey of DTCs found that over 92% of respondents had a DTC in their hospital. Composition was generally representational and most commonly included members from the disciplines of internal medicine, pharmacy and nursing. More than half the DTCs had executive authority although only 21% had an appeals mechanism. 6. The most commonly cited issues for DTCs in 1994-95 were quality drug use, drug policies and spending on high cost drugs. 7. While access to clinical pharmacologists and specialist drug utilisation evaluation (DUE) pharmacists was poor, 71% of DTCs had access to DUE data of some sort. Guidelines (61%), prescribing restrictions (60%) and pharmacist monitoring (63%) were the most commonly used strategies to implement DTC policies and decisions. Audit-feedback activities (61%) and drug bulletins (56%) were the most commonly used interventions. 8. Available information for formulary decision making varied with small rural hospitals having access to significantly less information. The most commonly used information was availability of a therapeutic alternative (87%), efficacy (83%), cost (80%) and estimated usage (78%). 9. On average DTCs reported an ability to implement 75% of decisions (range 0-95%) with teaching hospitals perceived to perform better than other hospital types. 10. This study reveals a high level of expectation for DTC activities and achievements. In Australia DTCs were involved in policy, education and management initiatives to promote best practice in therapeutics. Few committees appeared to have adequate resources to extend services to their wider community.

Australia↗
PubMed1994

An examination of therapeutic principles and practice in two forensic units.

The study reported here was conducted following claims made by a forensic psychiatric unit (called Ambrose Unit) that, in effect, it functioned as a therapeutic community. The study aimed to compare this claim with findings from the Attitude to Treatment Questionnaire (ATQ) that was administered to the staff of the unit. For the purposes of the exercise, the unit was matched with another similar unit that had not claimed to function therapeutically. It was hypothesized that, in keeping with their therapeutic claims, scores for staff from the Ambrose Unit would be more liberal than those for staff from the other unit (called Delphi unit). A series of ANOVA calculations supported this hypothesis and other hypotheses regarding political and social attitudes of staff working in these units. However, the discussion considers in more detail, scores from the ATQ, and questions these results. The nature of therapeutic community research in general is also considered and the validity of results generated from such research is discussed. Finally, the limitations imposed by the difficulty with which terms in this area are defined is acknowledged.

Analysis of Variance↗
PubMed2006

New potential antimalarial agents: therapeutic-index evaluation of pyrroloquinazolinediamine and its prodrugs in a rat model of severe malaria.

Tetra-acetamide pyrroloquinazolinediamine (PQD-A4) and bis-ethylcarbamyl pyrroloquinazolinediamine (PQD-BE) are new derivatives of pyrroloquinazolinediamine (PQD) and are being investigated as potential chemotherapeutic agents for the treatment of malaria. Comparative studies to assess the therapeutic indices of PQD-A4, PQD-BE, and PQD were conducted in Plasmodium berghei-infected rats following daily intragastric dosing for three consecutive days. Artesunate (AS), a standard drug for treatment of severe malaria, was used as a comparator. The minimum doses required to clear malaria parasitemia were 156 micromol/kg of body weight for AS and 2.4 micromol/kg for PQD, PQD-4A, and PQD-BE. The maximum tolerated dose (MTD) of AS was 625 micromol/kg, and its therapeutic index was calculated to be 4. The MTDs of PQD-A4, PQD-BE, and PQD were found to be 190, 77, and 24 micromol/kg, respectively, yielding therapeutic indices of 80, 32, and 10, respectively. Although PQD-A4 and PQD-BE are only half as potent as PQD based on their curative effects, the two new derivatives, PQD-4A and PQD-BE, are 8.0-fold and 3.2-fold safer, respectively, than their parent compound when they are dosed for three consecutive days. Oral PQD-A4 and PQD-BE are 44 to 70 times more potent on an mg basis than intravenous AS. As assessed from the therapeutic index over 3 days, PQD-A4, PQD-BE, and PQD administered orally are 20.0, 8.0, and 2.5 times safer than AS given intravenously. The results indicate that PQD-4A is a promising candidate for antimalarial treatment.

Animals↗
PubMed2006

The third generation of therapeutic communities: the early development of the TC for addictions in Europe.

AIMS: It is the goal of this study to investigate the first development of the drug-free therapeutic community (TC) in Europe. The paper aims at systemizing information, scattered all over Europe and is the first stage in an ongoing study to record the development of the European TC movement and its influences. DESIGN: After a study of the grey (hidden) literature, TC pioneers and experts per country were contacted to further elaborate the first findings. Subsequently, a preliminary summary of our findings was published in the Newsletter of the European Federation of Therapeutic Communities (EFTC), inviting additional information and corrections. The authors completed the results for this article with relevant first-hand information, obtained through interviews with European pioneers. FINDINGS: The findings are summarized under three topics: chronology, interconnections and European identity. It was found that from 1968 until 1989, a new therapeutic approach arose all over Europe, modeled after Synanon, Daytop and Phoenix House, New York, through Phoenix House, London and Emiliehoeve in the Netherlands. Therapeutic communities were established in Belgium, Finland, Germany, Greece, Ireland, Italy, Norway, Spain, Sweden and Switzerland as well. These communities were closely-knit and interconnected in their reaction against psychiatric and methadone treatment. The European TCs developed an own identity compared to the American ones. CONCLUSIONS: The European TCs adapted the model of their American predecessors to their own culture, influenced more by milieu-therapy and social learning. Instead of harsh behaviorism, more emphasis was placed on dialogue and understanding. Professionals occupied a more pivotal role and took over the dominant position of ex-addicts. Research, executed by TC professionals gradually entered the TC. A generic network of TC connections, through which the development evolved, was uncovered, and clear regional trends can be observed.

Europe↗
PubMed1992

Treatment of pulmonary arteriovenous malformations by therapeutic embolization. Rest and exercise physiology in eight patients.

Pulmonary arteriovenous malformations (AVM) lead to chronic hypoxemia and systemic emboli. These lesions can now be treated by catheter embolization. In order to examine physiologic abnormalities during exercise in AVM patients, and to evaluate functional improvement after therapeutic embolization, eight patients underwent detailed physiologic studies at rest and during exercise before and after therapeutic embolization. Before treatment, six patients noted dyspnea on exertion and three had symptoms suggesting paradoxical embolism. Resting studies showed hypoxemia, abnormally increased shunt fractions, chronic alveolar hyperventilation, mild decreases in diffusing capacity, and abnormal wasted ventilation (VD). During exercise, oxygenation changed little from the resting values but VD increased markedly. Functional impairment was observed in most patients, and was correlated with shunt fraction. Obliteration of the AVM was accomplished by therapeutic embolization with placement of coils or balloons in the feeder vessels. This treatment resulted in immediate relief of dyspnea and improvement in resting PaO2 and shunt fraction. Exercise studies after embolization showed improvement in exercise capacity and gas exchange. However, chronic alveolar hyperventilation and reduced diffusing capacity remained unchanged. In summary, therapeutic embolization effectively reduces the degree of shunting, with improvement in respiratory symptoms, exercise capacity, and gas exchange at rest and during exercise. The abnormally decreased diffusing capacity and increased VD suggest the presence of a diffuse pulmonary vascular abnormality, of which further study is warranted.

Adult↗
PubMed1982

The acute administration ward as a therapeutic community.

The authors evaluated six acute short-stay admission wards in a community mental health center using the sociometric Ward Atmosphere Scale. There was an attempt to run three of the six wards as therapeutic communities. No differences were found on Ward Atmosphere Scale dimensions between the therapeutic communities and other types of programs, nor did the therapeutic communities conform to an empirically derived therapeutic community program dimension profile. Possible reasons for this failure and its implications for community mental health centers are discussed.

Acute Disease↗
PubMed1981

Defining and understanding the therapeutic community.

The term "therapeutic community" has been used to describe a vast array of milieu therapy techniques; thus the term has come to mean different things to different people. The author defines the therapeutic community through an examination of its historical roots in the British military hospitals of World War II and the development of the treatment concept as an ideology. He classifies therapeutic communities as left, right, or center in their therapeutic ideology. It is in the communities of the center, the least dogmatic and most flexible typology, that the author finds hope for the most effective type of therapy.

Attitude of Health Personnel↗
PubMed1982

The therapeutic community: a critical reappraisal.

Any new concept or movement can be understood only when considered in light of the sociopolitical context in which it emerges. The authors critically assess the concept of the therapeutic community in such terms. They assert that the therapeutic community should be viewed as a protest movement itself, or as part of a greater protest against the dehumanizing conditions of mental hospitals in the early 20th century. As a protest movement it has achieved significant success. However, the author say, its therapeutic value has yet to be conclusively demonstrated and its practicability is also highly questionable. The authors suggest that the therapeutic community should be reassessed in light of changed social conditions, and a new and more pragmatic approach to organizing psychiatric hospitals be formulated.

Humans↗
PubMed1983

Product selection, bioequivalence, and therapeutic equivalence: the generic drug market.

Pharmacists are continually faced with drug product selection decisions. When is a generic drug product equivalent to the innovator product and, thus, a suitable candidate for generic substitution? The FDA policy has been that only drug products that are therapeutic equivalents are candidates for product selection decisions. This paper outlines the regulatory and scientific framework for the FDA's policies and requirements for generic drug products. The history and current status of the Drug Efficacy Study Implementation (DESI) project is described. Originally begun in 1966 as a review of about 3,400 drug products, the review in mid-1983 is more than 90% complete, but its impact has already affected more than 7,000 marketed drug products. The therapeutic equivalence policy and the manner in which decisions on therapeutic equivalence are communicated are reviewed. Regulatory policies for the approval of generic drug products are reviewed and specific litigation challenging the rights of generic drug manufacturers to produce generic "look-alikes" and challenging the FDA's policy that a generic drug product is a new drug requiring an approved New Drug Application for marketing is discussed. The conclusion reached is that the evaluation of regulatory requirements and science is leading to a point where all generic drug products will be known to be safe, effective and therapeutically equivalent, and pharmacists can be optimistic about the quality of products in the generic drug market.

Legislation, Pharmacy↗
PubMed1996

Therapeutic touch with adolescent psychiatric patients.

Seven hospitalized, adolescent psychiatric patients who received a total of 31 Therapeutic Touch treatments over two 2-week periods were interviewed about their experience. Findings from the interviews were categorized within 2 overarching themes-the therapeutic relationship and the body/mind connection. The study participants enjoyed the Therapeutic Touch, and in fact, they wanted more of it. This research shows the possibility of Therapeutic Touch as a nursing intervention with adolescent psychiatric patients if all care is taken to obtain their consent and to provide them with a safe environment for touch therapy.

Adolescent↗
PubMed1997

The state of research on the effects of therapeutic touch.

Therapeutic Touch is investigated using an integrative review of the literature. Using Ganong's (1987) methodology, the article explores the research question, What is the state of development of research regarding Therapeutic Touch? by analyzing primary research reports from 23 articles in 14 referred journals. The findings of the review indicate positive regard for the use of Therapeutic Touch. All research points to the need for further study in this area. Research methods used are satisfactory, but more rigorous methodologies would promote a more scientific contribution to the body of literature on Therapeutic Touch.

Data Interpretation, Statistical↗
PubMed1987

Therapeutic assessment of Slow-K and K-tab potassium chloride formulations in hypertensive patients treated with thiazide diuretics.

Therapeutic equivalency among different drug products is one of the major issues confronting many clinicians today who are functioning as members of pharmacy and therapeutic committees and state Medicaid programs (SMP). Selection of one of the available slow-release potassium chloride formulations for inclusion in a hospital formulary or SMP exemplifies one of these therapeutic equivalency issues. To evaluate this issue, we studied 20 hypertensive adult patients receiving hydrochlorothiazide 50 mg/d to determine if there are significant differences between the administration of 24 mEq of Slow-K given as 8 mEq/tablet tid, and 30 mEq of K-Tab given as a 10 mEq/tablet tid. The study was conducted in a randomized, open-label, crossover design in which the two drug formulations of potassium chloride were compared over two four-week treatment periods. Results from this study indicate that 24 mEq of Slow-K and 30 mEq of K-Tab were equally effective in maintaining serum electrolyte concentrations, blood pressure measurements, and electrocardiogram evaluations within normal limits in all 20 hypertensive patients studied. Furthermore, no adverse effects were noted with either potassium chloride formulation, and patient acceptance, tolerability, and compliance to prescribed dosing regimens were similar for both products. Based on our findings, therefore, we conclude that 24 mEq of Slow-K and 30 mEq of K-Tab given three times daily as 8 mEq and 10 mEq tablets, respectively, are therapeutically equivalent.

Adult↗
PubMed2006

Spontaneous and therapeutic abortions and the risk of breast cancer among BRCA mutation carriers.

INTRODUCTION: BRCA1 and BRCA2 mutation carriers are at increased risk for developing both breast and ovarian cancer. It has been suggested that carriers of BRCA1/2 mutations may also be at increased risk of having recurrent (three or more) miscarriages. Several reproductive factors have been shown to influence the risk of breast cancer in mutation carriers, but the effects of spontaneous and therapeutic abortions on the risk of hereditary breast cancer risk have not been well studied to date. METHODS: In a matched case-control study, the frequencies of spontaneous abortions were compared among 1,878 BRCA1 mutation carriers, 950 BRCA2 mutation carriers and 657 related non-carrier controls. The rates of spontaneous and therapeutic abortions were compared for carriers with and without breast cancer. RESULTS: There was no difference in the rate of spontaneous abortions between carriers of BRCA1 or BRCA2 mutations and non-carriers. The number of spontaneous abortions was not associated with breast cancer risk among BRCA1 or BRCA2 mutation carriers. However, BRCA2 carriers who had two or more therapeutic abortions faced a 64% decrease in the risk of breast cancer (odds ratio = 0.36; 95% confidence interval 0.16-0.83; p = 0.02). CONCLUSION: Carrying a BRCA1 or BRCA2 mutation is not a risk factor for spontaneous abortions and spontaneous abortions do not appear to influence the risk of breast cancer in carriers of BRCA1 or BRCA2 mutations. However, having two or more therapeutic abortions may be associated with a lowered risk of breast cancer among BRCA2 carriers.

Abortion, Spontaneous↗