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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↗
PubMed1983

A computer-assisted teaching system in pharmacology for health professionals.

In this report the authors describe experiences with a computer-assisted teaching system in teaching pharmacology to medical students and other health professionals. The system is composed of both computer-assisted instruction and computer-managed instruction. The "Keller Plan" philosophy was adopted, and the pharmacology course was organized into modules. Students were required to meet minimum proficiency requirements in each module and have multiple chances to reach this or higher levels. The advantages of this system are numerous. The department can provide both scheduled and independent study courses in basic pharmacology to students of different educational levels. Students can progress through a course at various speeds; that is, achievement is constant, but time is variable. Both the students and instructors are provided with frequent and rapid feedback. Most importantly, students with low aptitudes achieve significantly higher scores on the pharmacology portion of the examination of the National Board of Medical Examiners.

Computer-Assisted Instruction↗
PubMed2004

Training in paediatric clinical pharmacology in the UK.

AIMS: To produce a training programme in paediatric clinical pharmacology. METHODS: A working group, consisting of clinical pharmacologists (paediatric and adult), general paediatricians and the pharmaceutical industry was established to produce the training programme. RESULTS: Following a two year training programme in general paediatrics, a three year training programme in clinical pharmacology has been established. This includes one year of research in clinical pharmacology (paediatric or adult). The other two years involve training in different aspects of paediatric clinical pharmacology and general paediatrics. CONCLUSION: The existence of a formal training programme should result in a significant increase in the number of paediatric clinical pharmacologists.

Child↗
PubMed2004

Determining the reporting quality of RCTs in clinical pharmacology.

BACKGROUND: The Consolidated Standards for Reporting Trials (CONSORT) are recommendations for improving the quality of reports of randomized controlled trials (RCTs). OBJECTIVE: To determine the extent to which clinical pharmacology journals implement specific CONSORT recommendations. DESIGN AND SETTING: Analysis of RCTs published between May 2002 and May 2003 in four clinical pharmacology journals. MAIN OUTCOME MEASURES: Proportion of RCTs that published a participant flow diagram and that reported on randomization and restriction methods, allocation concealment, blinding, intention-to-treat analysis, ethical considerations, adverse events and source of funding. RESULTS: Of 482 clinical trials, 193 were RCTs. Healthy participants were involved in 129 [66.8%, 95% confidence interval (CI) 59.9, 73.1] trials, patients who required treatment in 61 (31.6%, 95% CI 25.4, 38.4) trials and both in three (1.6%, 95% CI 0.5, 4.4) trials. The following items were infrequently reported: sequence generation (17%), allocation concealment (3%), use of restriction (16%), description of blinding (26%), and flow diagrams of study participants (2%). In contrast, the following areas were often reported: use of intention-to-treat analysis (79%), description of withdrawals (92.2%) and description of adverse events (71%), ethics review (94%) and informed consent (95%). Sources of funding were reported in 56% of studies. CONCLUSION: The use of the selected CONSORT items is limited in these journals, possibly as many items may not be relevant to the types of studies published in clinical pharmacology journals. Further efforts are required to determine the applicability of CONSORT to RCTs in clinical pharmacology.

Humans↗
PubMed2004

Quality assurance program for clinical measurement of antiretrovirals: AIDS clinical trials group proficiency testing program for pediatric and adult pharmacology laboratories.

Clinical trials designed to compare antiretroviral regimens, investigate therapeutic drug monitoring, or measure pharmacometrics often include protease inhibitors (PIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), and nucleoside reverse transcriptase inhibitors, requiring the measurement of these antiretrovirals in plasma. Within the adult and pediatric AIDS Clinical Trials Group (ACTG), a network of Pharmacology Support Laboratories (PSLs) is a component of the group laboratory infrastructure and conducts these types of pharmacologic assays. The adult ACTG has developed a comprehensive quality assurance program for the conduct of clinical pharmacology protocols, one component of which is the antiretroviral proficiency testing (PT) program that has been implemented between the adult and pediatric pharmacology laboratories of the ACTG. PT testing samples were prepared and distributed in July 2001, February 2002, and July 2002. High, medium, and low concentrations of PIs (indinavir, saquinavir, amprenavir, lopinavir, ritonavir, and nelfinavir) and NNRTIs (nevirapine and efavirenz) were added to drug-free EDTA plasma and distributed, on dry ice, to eight ACTG PSLs. One testing laboratory used liquid chromatography-tandem mass spectrometry, and seven used high-performance liquid chromatography-UV analysis. A result was considered acceptable if it was within 20% deviation of the assigned concentration. For all concentrations of PIs evaluated, 96% of samples tested (430 of 448 measurements) met the acceptance criteria. For both NNRTIs, 100% of samples tested (140 of 140 measurements) met the acceptance criteria. In conclusion, the PT program results presented demonstrate excellent interlaboratory agreement for all antiretrovirals tested and provide support for the merger of plasma concentration data among laboratories for large clinical trials.

Acquired Immunodeficiency Syndrome↗
PubMed2000

Laboratory of Chemical Pharmacology, National Heart, Lung, and Blood Institute, NIH: a short history.

The Laboratory of Chemical Pharmacology (LCP) began in 1950 as the Section of Pharmacology within the National Heart Institute, the National Institutes of Health. Its first chief was Bernard B. Brodie, considered by many to be one of the fathers of modern pharmacology. Since its inception, LCP has made many significant contributions to the fields of pharmacology and toxicology. LCP was among the first to study (a) the effects of drugs on the turnover of serotonin and norepinephrine in brain and other tissues, (b) the absorption of drugs from the gastrointestinal tract and their passage across the blood-brain barrier, (c) the oxidation and reduction of drugs and other foreign compounds by liver microsomal enzymes (later known as the cytochrome P450 enzymes) and inhibitors and inducers of these enzymes, (d) the formation of toxic chemically reactive metabolites of drugs and other foreign compounds, and (e) mechanisms of immunological responses. Approximately 300 scientists worked in LCP during its existence, and they and their collaborators published more than 1,300 papers. This is a short history of the people who worked in it and of their contributions to biomedical sciences.

Animals↗
PubMed2006

Pharmacology and statistics: recommendations to strengthen a productive partnership.

Critical to the discovery, development and rational use of drugs and vaccines are the foundational principles and proper application of statistics. However, in too many cases, there has been misuse of statistics and/or overemphasis on statistical significance (p < 0.05), as though this criterion possessed truth-guaranteeing properties. To clarify confusion about the proper use of statistics in pharmacology, we summarize briefly the foundational principles of probability; the role of statistics in assessment of causality; the three basic uses of statistical methods, especially those employed in hypothesis testing; and current statistical issues in pharmacological research. We then review and provide examples of the meaning of statistical significance, the consequences of lack of randomization in epidemiology/observation studies, the criteria for measurement instrument validation, the problems with subgroup analyses, the need for multiple comparison statistical methods, and how to handle dropouts and missing data. Finally, based on sound experimental and statistical principles, we make a series of recommendations to both experimentalists and journal editors to improve published pharmacological experiments. These include widespread use of blinding and randomization and/or random selection of subjects in both basic and clinical pharmacology, mandatory use of rigorous evidentiary criteria in epidemiology/observation studies claiming causal associations, proper interpretation of statistical versus clinical/pharmacological significance, appropriate interpretation of meta-analyses, meaningful validation of methods, and a more rational statistical approach to subgroup analyses and genetic association studies.

Bias↗
PubMed2003

Teaching Pharmacology in 2010--new knowledge, new tools, new attitudes.

Changes in pharmacology teaching are being driven by various pressures. These originate: from changes in the discipline itself; from government; from professional bodies; from students; from changes in teaching styles and opportunities; from academic staff; from ethical/animal rights considerations; from employers and from higher education institutions. These changes will require an alteration in the knowledge, skills and attitudes of academic pharmacologists as much as they will require changes in the way teaching is delivered and learning is facilitated. Pharmacology courses will be provided in a changed environment and must prepare students to work in a changed discipline as well as being appropriate for students who will take employment in non-pharmacology areas. Change is likely to centre around the curriculum, problem based learning, simulated practicals, peer assessment, use of the internet, information technology and interactive computer based learning, virtual learning environments and integrated medical courses. The most effective strategy to achieve the necessary changes is likely to involve collaboration between pharmacology teachers on a global scale and a general consciousness among current academic pharmacologists that we need to ensure tomorrow's academics are well prepared for the changed environment in which they will have to work.

Attitude of Health Personnel↗
PubMed2006

Safety Pharmacology Society: 5th annual meeting.

This report summarises selected presentations delivered at the Safety Pharmacology Society annual meeting. Organ safety was covered, with cardiac QT liability being discussed most extensively. Of particular interest, was the lecture on beat-to-beat variability of cardiac repolarisation in anesthetised dogs with chronic atrioventricular block. This model, characterised by an electrophisyologically remodelled heart (replicating a human heart with reduced cardiac repolarisation reserve), was developed to assess the potential of drugs to cause unsafe QT prolongation that may spontaneously evolve into life-threatening arrhythmias. An interesting case study illustrated the apparent failure of safety pharmacology studies to accurately predict clinical QT liability due to an underestimated plasma concentration for therapeutic efficacy at early nonclinical stage. An emerging attractive new technology, presented as a means to minimise drug failure to reach marketing stage (attrition) dealt with biological fingerprinting which consists in placing drug candidates in the context of chemical, pharmacological, toxicological and clinical liability spaces available for marketed, withdrawn or failed drugs, as well as reference compounds. The meeting was an excellent occasion for sharing knowledge and technologies among members of this young society actively engaged in promoting safety pharmacology, a novel research activity which now plays a pivotal role in the drug development process.

Animals↗
PubMed2005

Application of transcriptome analysis to clinical pharmacology studies.

Clinical pharmacology is the investigation of drug effects in humans. This review discusses the basic tenets of clinical pharmacology research, including pharmacokinetic and pharmacodynamic analysis, therapeutic window, and clinical trial design, and the issues that may arise in the application of transcriptome analysis to clinical pharmacology studies. Examples of how transcriptome analysis can be applied to clinical pharmacology research are described, including a model system of endotoxin challenge (in vitro and in vivo), and an example of a cross-over drug study in normal volunteers. Various data display and analysis methods are also illustrated, including principal component analysis, hierarchical cluster analysis, and pathways analysis.

Animals↗
PubMed1999

[Chiral compounds and their pharmacologic effects].

The present contribution to the problems of the stereochemistry of drugs is an attempt at stressing the importance of a stereochemical view of pharmacology and at informing about the advances of "chiral pharmacology" within the framework of the contemporary knowledge of selective effects of drugs. There are no simple solutions in the "racemates versus enantiomers" problems and each substance must be considered and tested individually, i.e. on the case-by-case principle. For many racemates available at present there exist relatively few items of knowledge concerning the pharmacological, toxicological and pharmacokinetic properties of their individual enantiomers, or concerning the influence of age, health condition, sex and genetic factors on biological availability and response of the organism to the drug. Additional testing of the enantiomers of the racemates used in practice can lead to the discovery of new indications of the original drug, improve its clinical use and result in increasing its safety and efficacy. If it is so, in this case the "chiral meditations" in pharmacology are double worth the problems they pose.

Pharmaceutical Preparations↗
PubMed2000

[Responsibilities of clinical pharmacology in the early phase of drug development].

The path of a new drug from the idea to the product may be divided into 2 phases, namely drug discovery and drug development. Due to the scientific progress new and simple methods could be developed to determine the biological efficacy of a large number of compounds. During the first part of drug development necessary requirements for the first use in man are met by performing preclinical pharmacological, toxicological and pharmacokinetic investigations in the animal and in in-vitro testing. After a first clinical-pharmacological profile of the new substance has been established during phase I on the basis of which a decision for the continuation of the clinical trial is made, the aim of phases II and III is now to answer the important questions of the therapeutic efficacy and tolerability in a large number of patients with the target indication. Due to the continuously increasing time and costs of drug development, drug development should be streamlined combining preclinical and early clinical phases as an exploratory stage and later clinical development as a confirmatory stage. The development and appropriate use of surrogates and models may be helpful to determine drug actions in human and to assist in dose selection as the main requirement for a successful large clinical trial in the confirmatory stage. Identifying the genes responsible for the huge variations in how different patients respond to a drug, in terms of both the product's effectiveness and its side effects, and genotyping patients before including in large clinical trials may prevent selecting the wrong patient population and avoid expensive repetition of these studies. Taking responsibility as the link between research and development gives clinical pharmacology a major opportunity to assume a pivotal role in drug development. To reach this goal, clinical pharmacology must be fully integrated in the whole process of drug development from the candidate selection until the approval.

Animals↗
PubMed2001

[Multimedia methods for the teaching of pharmacology].

Pharmacology is by definition a subject of integration. Students take on a passive role during the learning process and do not count with image aids that could foster understanding, fixation and evocation. Therefore, a hypermedia pharmacology CD ROM program was developed. Such a program includes the following features: hypertext format set up as a network of nodes and arcs, multimedia technology, highly interactive and customized navigation. The prototype thoroughly develops cholinergic neurotransmission pharmacology in its historical, anatomic, physiological, biochemical, pharmacological and therapeutic aspects. The program is divided into three modules; namely, information, exercises and evaluation. Each network node may contain a text, hypertext, images, 3D animation and experimental videos. Information resources include the navigation conceptual map for the chosen node, a track record to go back or forward immediately, the possibility of adding text or images, a text search function, images, animation and videos to find such objects in the different nodes together with the possibility of printing any of the contents. Apart from the information framework, the model has manifold useful integration exercises to assess the learning improvement and prompt the student accordingly to review the topic whenever mistakes exceed a certain amount. This program promotes knowledge integration and building through association of contents. To access to the program's demo, consult the following page.

Computer-Assisted Instruction↗
PubMed2002

Pharmacological applications of magnetic resonance imaging.

Magnetic resonance imaging (MRI) techniques are capable of spatial and temporal resolution and within subject repeatability that far exceed other currently available methods of noninvasively investigating brain functioning. While functional MRI (fMRI) techniques have traditionally been used to investigate sensory, motor, and cognitive functions, they are also very attractive for investigating the effects of pharmacological agents in the brain. However, because pharmacological agents may interfere with the very mechanisms that give rise to the fMRI signal, careful attention to experimental design and data analysis issues must be exercised. Specifically, introducing a drug into the system could potentially alter the coupling of neural activity with regional cerebral blood flow and/or the extraction of oxygen from blood, or may cause local or global cardiovascular changes unrelated to neural activity. These concerns notwithstanding, careful attention to experimental detail and verification procedures promises to make pharmacological MRI a valuable tool for understanding the actions of drugs on the brain at many levels. The physiological and biophysical bases of blood oxygen level-dependent, arterial spin labeling, cerebral blood flow, cerebral blood volume, and spectroscopy acquisition methods are presented to illustrate where confounds may arise when a drug is added to the system. Selected studies combining administration of pharmacological agents with MRI techniques are critically reviewed to illustrate both the challenges inherent in these applications and some possible solutions. Included are studies of acute direct effects of drugs, effects of drugs on task-related activation, chronic effects of drugs, effects of drugs on cerebral metabolism, and variable effects of drugs in different populations.

Animals↗
PubMed1992

[Clinical pharmacology: current status and perspectives].

In view of the ever increasing complexity of individualized pharmacotherapy, the study of new and potent drugs in man and the misuse and abuse of drugs, WHO-Study Group reports and a recent enquiry in Belgium, France and W. Germany stress that the development of clinical pharmacology is an absolute necessity for patients, physicians, health authorities, the pharmaceutical industry and society at large. It seems this development could be optimally achieved by setting up, within Services of General Medicine or Internal Medicine of University Hospitals and large Public Hospitals, autonomous Units of Clinical Pharmacology with the responsibility to take an active part: a) at the service level: 1) in patient care, either directly in general medical services or drug problem oriented consultations, or indirectly through consultative functions and pharmacotherapeutic conferences; 2) in drug monitoring services, management of cases of overdose, drug information, drug utilization surveys, pharmaco-epidemiology, ethical committees, formulary committees, drug regulatory agencies and studies of Phase I, II and III; b) at the teaching level: 1) in courses of clinical pharmacology sui generis, to undergraduates, in close collaboration with the University Department of Pharmacology; 2) at the postgraduate level, as a specialty in se, and as part of the training in medical specialties and at the level of continuing education of general practitioners and specialists; c) at the research level: 1) in clinical pharmacokinetic studies, with special attention to interindividual variability and genetic factors, to drug concentration/effect studies, to drug interactions, and in pharmacodynamic studies, in view of the development of new approaches in the study of drug-receptor interactions; 2) in the design, realization and evaluation of Phase I, II and III studies, clinical trials and multicenter drug studies.

Belgium↗
PubMed1984

Reducing 'information overload' in the teaching of pharmacology: the '200 Drug List'.

The author in this report describes the development and use of a restricted list of drugs in the medical pharmacology course at the Medical College of Georgia (MCG) School of Medicine. The "200 Drug List" was developed by the author by analyzing recent examinations given to students at the MCG and other places. The list contained 60 percent fewer drugs than had been taught in the course in prior years. Only those drugs on the list appeared on subsequent pharmacology examinations, regardless of the scope of the teaching program. Despite the limited number of drugs that the students were required to learn to satisfy the requirements of the teaching program, the average score for the class on the pharmacology subtest of the National Board of Medical Examiners Part I examination improved each year since the new approach was adopted. The 200 Drug List concept is viewed as an effective way to reduce the "information overload" for students without sacrificing the quality of an introductory course in pharmacology.

Education, Medical, Undergraduate↗
PubMedDate not supplied

Questions of the end of the century and millennium. Ecologic pharmacology.

The author starts from the idea that drugs are factors of the external environment, which can produce the pollution of the organism. This raised the problem of the necessity to practice an ecologic pharmacology. Referring to the drugs as part of the material, the author underlines that they represent a unit, substance-energy-information. He considers that the pharmacologic effects are the result mainly of information transmission, while the pharmacotoxicologic effects are produced by substance. There is a single way to reduce the toxic effects, by diminution of the dosage, which is achieved by homeopathy. The author proposes that pharmacology should include two branches, allopathy and homeopathy, the only possibility to perform a pharmacology with a dominant, defining ecologic character.

Drug-Related Side Effects and Adverse Reactions↗
PubMed2006

The rate of bleeding complications after pharmacologic deep venous thrombosis prophylaxis: a systematic review of 33 randomized controlled trials.

HYPOTHESIS: Major bleeding complications from pharmacologic deep venous thrombosis (DVT) prophylaxis are infrequent. DESIGN: Systematic review of the MEDLINE database from 1965 to August 2005, using the terms DVT, prophylaxis, general surgery, and heparin. SETTING AND PATIENTS: Randomized controlled trials evaluating pharmacologic DVT prophylaxis in patients undergoing general surgery. MAIN OUTCOME MEASURES: Eight complication categories: injection site bruising, wound hematoma, drain site bleeding, hematuria, gastrointestinal tract bleeding, retroperitoneal bleeding, discontinuation of prophylaxis, and subsequent operation. RESULTS: Fifty-two randomized controlled trials studied DVT prophylaxis; 33 randomized controlled trials with 33 813 patients undergoing general surgery evaluated pharmacologic prophylaxis and quantified bleeding complications. Of the minor complications, injection site bruising (6.9%), wound hematoma (5.7%), drain site bleeding (2.0%), and hematuria (1.6%) were most common. Major bleeding complications, such as gastrointestinal tract (0.2%) or retroperitoneal (<0.1%) bleeding, were infrequent. Discontinuation of prophylaxis occurred in 2.0% of patients and subsequent operation in less than 1% of patients. When analyzed by high- vs low-dose unfractionated heparin, the lower dose had a smaller rate of discontinuation of prophylaxis (P = .02) and subsequent operation (P = .06). CONCLUSIONS: Knowledge of bleeding complication rates is important for surgeons because DVT prophylaxis may soon be implemented by Medicare as a quality measure. This level 1 evidence report shows that bleeding complications requiring a change in care occur less than 3% of the time and seem reduced with lower-dose prophylaxis. Given these findings, most patients undergoing general surgery could receive pharmacologic prophylaxis safely.

Anticoagulants↗