Clinical Pharmacology Training Research Articles

Clinical pharmacology and the faculty of pharmaceutical medicine.

Clinical pharmacology and the faculty of pharmaceutical medicine.

An Update on the Therapeutic Orphan

Thirty years ago, Dr Harry Shirkey recognized the serious dilemma of pediatric drug labeling, called therapeutic orphan, to capture its concept, and described remedial measures to minimize the dilemma. This review offers a brief exposition of the therapeutic orphan's arduous journey toward the goal of labeling of all drugs used for children. Aside from legal and US Food and Drug Administration (FDA) policy requirements to secure new drug application approval to market a drug, some may question reasons for a pediatric drug label, especially if a label exists for adult use and pediatric use information is distributed in literature reports. Major pragmatic reasons for a pediatric label are presented in Table 1. A label testifies to carefully reviewed clinical trial data that offer substantial evidence to support pediatric indications for which the drug has approved use. Perhaps of unappreciated importance is availability of information on the label. Time-consuming literature review and analysis often are not necessary when a pediatric label exists. Label information is compiled for the pediatric drug formulation, and it is this formulation that is approved. Literature reports often contain one or more formulations prepared by the investigator, and good manufacturing procedures or bioavailability estimates may be less than desired. A formulation on the label frequently has been evaluated for characteristics acceptable to children and hence compliance is strengthened. The drug, having met pediatric labeling requirements, is available for children and obviates the awkward double standard—one for adults (label necessary for marketing) and one for children (pediatric label not necessary for marketing or use). To the lay public, this pediatric labeling allows third-party reimbursement of drug costs otherwise denied. This relieves young parents of a truly indefensible economic burden, which in some cases has denied drug treatment to children. Add to this the refusal of some malpractice … Address correspondence to John T. Wilson, MD, Section on Clinical Pharmacology, Department of Pediatrics, Louisiana State University Medical Center, Shreveport, LA 71130.

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

To obtain information about the speciality of clinical pharmacology and therapeutics in the United Kingdom. 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%. 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. 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.

Survey of clinical pharmacology training in the United States and Canada

A survey of 139 medical schools in the United States and Canada was conducted in 1993-1994 to determine where active training programs in clinical pharmacology were located. A secondary survey of clinical pharmacology program directors followed in 1994-1995. Thirty-nine active programs were identified where 113 fellows (84 physicians and 29 nonphysicians) were enrolled. Sixty-eight percent of current physician fellows were trained in internal medicine before they entered their clinical pharmacology program. Forty-four percent of trainees were reported to be U.S. citizens. Fewer than 20 fellows complete training each year. The reported content of training programs was 12% didactic, 72% research, 12% clinical service, and 9% supervised teaching. Funding sources for trainees varied considerably. Nearly 50% of trainees were supported all or in part by funds from the National Institutes of Health (NIH), and approximately 40% relied on international sources of support. No correlation between salary and funding source or fellow degree was found. Nearly two-thirds of recent program graduates obtained employment in an academic setting, whereas 15% entered the pharmaceutical industry. These data indicate that subspecialty training in clinical pharmacology is available at 39 medical schools in the United States and Canada. Current fellowship training is primarily research based and nearly equally supported by NIH and international sources.

A new opportunity for training in Clinical Pharmacology

A new opportunity for training in Clinical Pharmacology

Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists

Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists

Survey of Clinical Pharmacology Training in North American Medical Schools

Clinical Pharmacology & Therapeutics (1996) 59, 212–212; doi: 10.1038/sj.clpt.1996.346

Physician Assistants and Nurse Practitioners

Letters1 August 1995Physician Assistants and Nurse PractitionersLucinda G. MillerLucinda G. MillerSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-123-3-199508010-00021 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:The American College of Physicians recently voiced its position on the role of nonphysician health care providers [1]. The College recognizes the need for an expanded role of nonphysicians to meet future demands for primary health care. The debate on midlevel practitioners has previously focused on physician assistants and nurse practitioners. I suggest that a third group of practitioners—clinical pharmacists—also be considered.Equipped with extensive didactic and clinical pharmacology training, PharmDs and other clinical pharmacists are often called on by physicians, physician assistants, and nurse practitioners for therapeutic consultations. (At our institution, 9 hours of pharmacology and ...

Medication use and the elderly: current status and opportunities.

The crucial role played by medication use in the elderly is common knowledge in the worlds of health services research, clinical epidemiology, and geriatrics. It is now widely known that although persons over age sixty-five represent only about 13 percent of the population, they consume nearly one-third of all medications in the United States; that medications probably are the single most important health care technology in preventing illness, disability, and death in the geriatric population; that drugs represent one of the largest and fastest-rising out-of-pocket health care expenditures for the elderly; and that the old, because of their high drug usage rate, greater frequency of coexisting illnesses, and diminished physiological reserves, are at greater risk of experiencing adverse drug effects. Yet despite this knowledge, the use of drugs by the elderly and their clinical outcomes have not been prominent research or programmatic priorities for federal government, philanthropic, or corporate grantmakers. Beginning in the mid-1980s, The John A. Hartford Foundation began a grant-making program in the area of medication use and aging, out of an interest in enhancing the therapeutic effect of drugs used by this age group and in reducing the frequency and consequences of adverse drug events. After a number of years of active support in this area, the foundation convened its Expert Panel on Medications and Aging. This panel brought together authorities in the disciplines of geriatrics, gerontology, epidemiology, health services research, public policy, and pharmacology. Its mandate was to provide a consensus report that would critically define the further work needed to make the use of medications by the elderly more effective. This essay represents a synthesis of the work of that panel. The positions and opinions expressed below are extracted from transcripts of the expert panel’s deliberations, a structured survey administered to panel members,

Postmarketing surveillance: curriculum for the clinical pharmacologist. Part II: Clinical and regulatory considerations.

This is the second of a two-part series that develops a curriculum on postmarketing surveillance. With the ongoing emphasis on drug safety and possible earlier marketing of drugs, this becomes an essential element of clinical pharmacology training. The usual educational focus on drug safety is a pharmacokinetic or pharmacodynamic perspective on a specific drug or drug class, perhaps in the context of clinical trial study design and analysis. This curriculum complements this approach and provides an overview of drug safety surveillance from regulatory and epidemiologic perspectives.

Principles of drug prescribing in infants and children. A practical guide.

Paediatric prescribing is much more complicated than prescribing for adults. The specific and general aspects of paediatric patients, the limitations of commercially available dosage formulations, the vagaries of administering medicines, the general inadequacy of clinical pharmacology training, and the dearth of information about drug use in children all add to the difficulties facing the practitioner who treats infants and children. For these reasons practitioners should prescribe judiciously, select carefully the safest dosage regimen available, and educate their patients, caregivers and staff about their choices and expected positive and negative effects. Practitioners should also have available and use written, electronic, as well as human sources of expert advice. They should write all prescriptions legibly and carefully, document their therapeutic decisions and plans, and carefully monitor their patients' responses to therapy. Careful attention to the principles of clinical pharmacology can do much to improve the efficacy of paediatric prescribing and decrease its costs and risks.

Clinical pharmacology training at the Food & Drug Administration.

Challenged with the clearly demonstrated need for highly trained clinical pharmacologists for new drug development and review activities, the FDA Center for Drug Evaluation and Research (CDER) established an internal Staff College. This organizationally unique and innovative unit addressed the educational needs of both the new and the veteran CDER scientists. A multileveled strategy was conceptualized and implemented as described.

A study of training in clinical pharmacology of the elderly.

Training of physicians in geriatrics is essential to improving health care for the elderly. Considering the frequent use, cost, and side effects of drugs in the elderly, knowledge in clinical pharmacology is an important component of that training. The present study surveyed 68 geriatric medicine, 27 geropsychiatry, and 46 clinical pharmacology fellowship programs in the United States for the clinical geropharmacology content of their programs. In geriatric medicine, 73% of the programs had formal didactic material, 58% had formal training in this area during clinical experiences, and 43% formally interacted with clinical pharmacology faculty or fellows. In geropsychiatry these numbers were 79%, 67%, and 31%, respectively. In clinical pharmacology, 34% of the programs had formal didactic content, 9% had clinical experience on a specific geriatrics unit, and 14% had clinical experiences in a long-term care facility. Although some training in clinical geropharmacology exists in fellowship training programs, clearly there is much room for expansion and improvement in this important area of health care of the elderly.

Current status of clinical pharmacology training in the United States.

Current status of clinical pharmacology training in the United States.

Political and Legal Aspects of Pharmacist Prescribing

The appropriateness of pharmacist prescribing is examined, and limits that should be incorporated into legislation are discussed. Arguments that support pharmacist prescribing are that (1) in current practice, pharmacist consultation has evolved into prescribing; (2) there is a need for pharmacists to prescribe; (3) nurse practitioners and physicians' assistants, whose training in clinical pharmacology is conducted by pharmacists, have authority to prescribe in many states; (4) as the need for dispensing functions decreases, new functions must be assumed; and (5) pharmacist prescribing in pilot studies has been safe, effective, and either equal or superior to physician prescribing. Negative aspects of pharmacist prescribing include (1) not all pharmacists are competent to prescribe, (2) pharmacists are not trained in diagnosis, (3) physicians oppose it, (4) it could increase patient-care costs, and (5) pharmacists' access to patient information is not adequate for competent prescribing. Based on these arguments, legislation regulating pharmacist prescribing should contain certain limits: (1) certification to prescribe should be based on demonstrated competence, (2) pharmacists who prescribe must have access to medical records, (3) pharmacists must prescribe within established working relationships with physicians, and (4) pharmacist prescribing should be limited to long-term therapy for chronic disease and therapy for acute self-limiting illnesses that are not diagnostically complex. These limitations have been incorporated into California law. A bill is pending that allows pharmacists, within specified guidelines, to initiate drug treatment.

Clinical pharmacology-training and career.

As young physicians, attending and participating in various postgraduate clinical pharmacology training programmes, it is our experience that many of our clinical colleagues are not informed about (i) the definition or functions of a clinical pharmacologist, (ii) postgraduate education opportunities, or (iii) career prospects in this field. By reviewing the training and career opportunities in a country in which the speciality is well-developed (Great Britain) it may be possible partly to answer these points.

Training in clinical pharmacology.

Clinical pharmacology is only one of many disciplines whose jugular vein has just been slashed by the myopic budgetary decisions of the Nixon administration. The belief that military spending is more crucial to our nation's survival than support of science or the handicapped or the poor is one that strikes many of us as a philosophy of despair.

Training program in clinical pediatric pharmacology

A Clinical Pediatric Pharmacology unit has been established in the Department of Pediatrics, Children's Memorial Hospital, University of Oklahoma Medical Center. Fellowships for training in clinical pediatric pharmacology in the unit are now being offered. The program is designed especially for those interested in a career in academic medicine or in intensive clinical investigation relating to drug metabolism.

Training in clinical pharmacology and experimental therapeutics

Training in clinical pharmacology and experimental therapeutics

Training in Clinical Pharmacology and Experimental Therapeutics

An unfortunate academic perspective concerning L therapeutics has been carried over from the past into the present. Many of our outstanding medical schools maintain the attitude that pathophysiology of medical diseases and the art and science of diagnosis are all-important in medical education, and that "any fool can treat." This may have been appropriate 40 years ago, when effective therapeutic agents were indeed few in number, but the concept is hardly applicable today. With the development of new and potent agents, the administration of these agents must become as specific and precise as the surgeon's knife, if maximum therapeutic benefit is to be obtained. An even more unfortunate corollary is the attitude of some who take great pride in considering themselves "therapeutic nihilists." Among these are a number of academicians who, by virtue of their position, have great influence on their students. As a result, many of our newly graduated