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PubMed1991

Dealing with substance abuse in the workplace.

Substance abuse within the workplace affects both the employer and the employee. A decrease in morale and an increase in accidents and sick calls can contribute to significant financial losses for an institution. This article discusses ethical and legal considerations in developing substance abuse policies and employee assistance programs. A proactive approach intended to prevent substance abuse and exert greater control over the problem with resulting decreases in the waste of valuable human resources is presented.

Drug and Narcotic Control↗

PubMed1983

Training the "clinical scientist" through a combined industrial/academic fellowship.

A novel two-year fellowship program is described which provides specialized training both in clinical drug research and drug development methodology for pharmacists with previous clinical experience. Pharmaceutical industry, university and hospital research facilities are used as the training laboratories, and collectively offer theoretical as well as practical research skills development. Traditional didactic and laboratory training are provided within university and hospital environments with emphasis in the conduct of clinical trials. Extramural experience with pharmaceutical industry provides a corollary experience which includes exposure to ethical, legal and regulatory issues involving both investigational and marketed drugs. Following successful completion of the fellowship, the pharmacist is expected to have developed the fundamental skills necessary for a career in academia, pharmaceutical industry, or clinical practice.

Drug Industry↗

PubMed2004

[Anticancer drugs off label used of: what do the experts think about?].

Anticancer drugs off label used in Tenon hospital were analysed by a panel of 12 experts not working at Tenon hospital. They distinguished 3 groups of off-label prescribing according to scientific evidence, labelling anticancer drugs alternative in presence and patient's characteristics: justified off label used (62%), unjustified off label used (26%) and prescriptions for which no consensus had been reached between the experts (12%). Nineteen per cent of unjustified off label used had labelling alternative and 7% did not have anticancer drugs labelling alternative. Questions who experts had to answer to analyse drugs prescribing could be systematically asked when a chemotherapy is prescribed. It could allowed to take into account scientific, economic and ethical requirements. This method proposed by the local drug committee could be used to regulate economic resources and to justify financing of some expensive anticancer drugs.

Antineoplastic Agents↗

PubMed2004

[The advertising of medicinal products to the public in Poland--legislative, ethical, health and social concerns].

Regulations regarding the advertising of medicinal products to the public in Poland, EC directive and WHO ethical criteria for medicinal drug promotion were compared. Current Polish regulations varied considerably with Community's and WHO point of view. The article covers the potential health and social effects of the recent situation in the area of medicines advertising in Poland.

Advertising↗

PubMed1988

A clinician's guide for conducting randomized trials in individual patients.

In determining optimal treatment for a patient conventional trials of therapy are susceptible to bias. Large-scale randomized trials can provide only a partial guide and have not been or cannot be carried out for most clinical disorders. However, randomized controlled trials (RCTs) in individual patients (N of 1 RCTs) may in some circumstances provide a solution to this dilemma. In an N of 1 RCT a patient undergoes pairs of treatment periods (one period of each pair with the active drug and one with matched placebo, assigned at random); both the patient and the clinician are blind to allocation, and treatment targets are monitored. N of 1 RCTs are useful for chronic, stable conditions for which the proposed treatment, which has a rapid onset of action and ceases to act soon after it is discontinued, has shown promise in an open trial of therapy. The monitoring of treatment targets usually includes quantitative measurement of the patient's symptoms with the use of simple patient diaries or questionnaires. Pairs of treatment periods are continued until effectiveness is proved or refuted. The cooperation of a pharmacy is required for the preparation of matching placebos and conduct of the trial. Formal statistical analysis may be helpful for interpreting the results. The practical approach presented in this paper allows clinicians to conduct their own N of 1 RCTs.

Clinical Trials as Topic↗

PubMed1977

Levels of satisfaction among hospital pharmacists.

Hospital pharmacists in a Midwestern, metropolitan area were surveyed to determine levels of job satisfaction. Of the 195 pharmacists who received the 120-item questionnaire, 132 (68%) responded. The questionnaire included facet-free questions which reflect the overall satisfaction of an individual with his job. Results to these questions were compared to those for professional, managerial and nonprofessional workers in two University of Michigan Surveys of Working Conditions. Also included in the survey were facet-specific job satisfaction measures from the Minnesota Job Satisfaction Questionnaire. The study found an overall pattern of less satisfaction among hospital pharmacists than among workers included in the Michigan surveys. The data indicate that hospital pharmacists might be less committed to their jobs and more likely to change jobs than other employees. Compared to other employees, hospital pharmacists showed a greater commitment to the work ethic and were more dissatisfied with their general life situation. The average general job satisfaction score of the respondents was 2.53, on a five-point scale, indicating something less than "satisfied". Pharmacists were least satisfied with the lack of opportunity for advancement, staffing practices, employer's policies and practices, and compensation practices. Compensation relative to others and amount of compensation were the sources of greatest satisfaction. Staff pharmacists had the lowest level of satisfaction; clinical pharmacists the highest--other personnel categories compared were directors, associate and assistant directors, and supervisors. The profession of pharmacy should decide whether or not to be concerned with the general low level of satisfaction among hospital pharmacists.

Attitude↗

PubMedDate not supplied

Policy decisions about the human genome.

The application of genomic technology to drug development and therapy will lead to safer and more effective therapies. Elucidation of the human genome poses numerous social, ethical and legal issues, such as the possible misuse of genetic information to discriminate against a person in the workplace or through denial of insurance coverage. Pharmacists need to stay current with advances in genetic medicine and prepare themselves to use this information to optimize drug discovery and drug therapy.

Drug Therapy↗

PubMed1991

Hydroxyurea as treatment for sickle cell anemia.

Hydroxyurea may be the most promising drug suggested thus far as a treatment for patients with sickle cell anemia, but its safety and efficacy remain unproved, and it probably will not be evaluable for several years. It is not "the answer" for the disease, it seems likely that crises will not be eliminated by treatment, and at this time its use should be reserved for seriously affected adult patients who can participate in a controlled clinical trial. Every hematologist, internist, or pediatrician sees a few patients who are so severely afflicted by sickle cell anemia that their lives seem totally blighted. It is very tempting to consider treating them with hydroxyurea, because the drug is available in any pharmacy, but it is equally important to consider whether the treatment would accomplish any more than treating the physician's own sense of futility, or making the patient feel that "something was being done." If hydroxyurea were as safe as folic acid, treatment for these purposes would be reasonable. It is not, but its use may still be appropriate (although illegal unless used under an Investigational New Drug Agreement, because its use for this purpose is not approved by the FDA). Whether or not it is legal, prescription of hydroxyurea for patients with sickle cell anemia would be ethical or proper only if the potential risks, the variability of the Hb F response, and the lack of proof of clinical efficacy were clearly explained to potential recipients.

Anemia, Sickle Cell↗

PubMedDate not supplied

[Drug-related clinical research--a practical opportunity for the hospital pharmacist].

OBJECTIVE: To describe a pharmacist s field of activity in drug-related clinical trials. METHOD: A non-systematic assessment of available scientific literature in international databases queried during the period of May 05 to 31, 2005. RESULTS: In all, 36 papers were obtained regarding the role of hospital pharmacists in the development of drug-related clinical trials. Most common activities included dispensation, storage, and inventory. Participation in ethics committees and study coordination represent an expanding area. CONCLUSIONS: Drug-related clinical research is an excellent practical setting for the hospital pharmacist. Activities related to investigational drug control, including dispensation, randomization scheme management, and patient follow-up, are an example. This is a novel though rapidly expanding scenario in Brazil.

Biomedical Research↗

PubMed2006

Revisiting pharmacists' refusals to dispense emergency contraception.

Pharmacists' refusals to fill prescriptions for emergency contraceptives for reasons of conscience have contributed to a national debate regarding the permissibility of such actions. Some in the medical community assert that pharmacists ought not to refuse to dispense emergency contraceptives on this basis. Three lines of argument have become prominent in defense of that position: 1) the professional status of pharmacists does not allow for refusal to dispense legitimately written prescriptions, 2) the medical facts regarding the mechanism of action of emergency contraception are often misunderstood, misrepresented, or both, and 3) refusals by pharmacists to fill legitimate prescriptions undermine patient care. In this commentary, these arguments are rejected as missing the central point of the issue, which is that pharmacists are autonomous, moral agents who are accountable for their choices and entitled-within limits-to decide in which activities they will participate. Pharmacists' professionalism is defended, their responsibilities in the provision of drug therapy are set forth in the context of pharmaceutical care, and these lead to the conclusion that pharmacists' refusals may be ethically justified. There are important limits on how pharmacists may respond when they are being asked to participate in actions they find morally objectionable. Notably, they must ensure that these prescriptions are filled by someone else in a timely manner and must refrain from any abusive or demeaning treatment of patients, as summed up in our Principle of Conscientious Refusal to Dispense.

Contraceptives, Postcoital↗

PubMed2003

[A study of treatise on medicine by King Sejo].

This paper explores historical backgrounds and contents of Treatise on Medicine written by King Sejo (r. 1455-1468) including his views on traditional medicine and pharmacy in the early Chosen period. The Treatise declared by King Sejo in 1463 has been considered as an important and unique manual of medicine because it was the exclusive example written by the king of Chosen. It was the King Sejo' s era when the medical milieu in both social and medical aspects was highly encouraged thanks to the previous achievements by King Sejong the Great (r.1418-1450). King Sejo, in particular, who was much interested in practical learning called 'Miscellaneous Studies', emphasized on court medicine. His writing can be understood in such historical frame. Another reason why he wrote the Treatise can be said that he felt necessary for establishing the medical ethic codes for inefficient court medicine-officials. In personal background, he tried to find available remedies since he had been suffered from some chronic diseases. The contents of the Treatise can be broadly fallen to the clinical and ethical aspects. In the former one, the Treatise focuses on treatment without hesitation through the sharp and exact diagnosis by medical doctors. In the latter one, eight categories of medical doctors are discussed according to their moral degrees: sim'eui, sik'eui, yak'eui, hon'eui, kwang eui, mang'eui, sa'eui, and sal'eui. Finally, musim' ji-eui was supplemented. Among them, sal'eui, medicine-official lacking both medical ability and ethical attitude, was classified as the lowest degree; sim'eui, medicine-official sincerely making his all efforts for patients, was thought to be a paragon of medical morality. In conclusion, the Treatise on Medicine by King Sejo played an important role as a manual for the principle of medical practice and for the instruction to enhance ethical attitude among medicine-officials.

Famous Persons↗

PubMed2006

[Problems in hospital preparation of acute poisoning antagonist (methylene blue injection)].

Since some antagonists or antidotes in cases of acute poisoning are not commercially available in Japan, in many hospitals they are prepared on their premises for clinical use. However, no specific legislation for the procedures of quality assurance and informed consent of these hospital-prepared products as yet exists. Further, the standard procedures for clinical use of the hospital-prepared products have yet to be established. For the treatment of patients with methemoglobinemia, we prepared methylene blue for injectable use in our hospital. In this paper, we describe our procedures ranging from its preparation to clinical use of this product. Methylene blue injection was prepared by using reagent-grade chemicals. The quality of hospital-prepared methylene blue injection was examined in accordance with the United States Pharmacopoeia. The contents of methylene blue injection remained constant at room temperature during storage for 12-month. The sterility testing also gave negative results during the same period. In order to obtain approval for its clinical use by the in-hospital ethical committee, relevant documents such as instructions for the preparation method, product information on safety usage and consent form were created. After these procedures, clinical applications of methylene blue injection were finally initiated.

Acute Disease↗

PubMed2005

Academic administrators' attitudes towards interprofessional education in Canadian schools of health professional education.

Interprofessional education is an approach to educating and training students and practitioners from different health professions to work in a collaborative manner in providing client and/or patient-centred care. The introduction and successful implementation of this educational approach is dependent on a variety of factors, including the attitudes of students, faculty, senior academic administrators (e.g., deans and directors) and practitioners. The purpose of this study was to examine attitudes towards interprofessional teamwork and interprofessional education amongst academic administrators of post-secondary health professional education programs in Canada. A web-based questionnaire in English and French was distributed via e-mail messaging during January 2004 to academic administrators in Canada representing medicine, nursing, pharmacy, social work, occupational therapy and physiotherapy post-secondary educational programs. Responses were sought on attitudes towards interprofessional teamwork and interprofessional education, as well as opinions regarding barriers to interprofessional education and subject areas that lend themselves to interprofessional education. In general, academic administrators responding to the survey hold overall positive attitudes towards interprofessional teamwork and interprofessional education practices, and the results indicate there were no significant differences between professions in relation to these attitudinal perspectives. The main barriers to interprofessional education were problems with scheduling/calendar, rigid curriculum, turf battles and lack of perceived value. The main pre-clinical subject areas which respondents believed would lend themselves to interprofessional education included community health/prevention, ethics, communications, critical appraisal, and epidemiology. The results of this study suggest that a favourable perception of both interprofessional teamwork and interprofessional education exists amongst academic administrators of Canadian health professional education programs. If this is the case, the post-secondary system in Canada is primed for the introduction of interprofessional education initiatives which support the development of client and patient-centred collaborative practice competencies.

Administrative Personnel↗

PubMed1995

Bioequivalence. An updated reappraisal addressed to applications of interchangeable multi-source pharmaceutical products.

This paper reviews study procedures for bioequivalence trials, mainly addressed to the New Drug Application (NDA) of generic drugs, strictly referring to EU and USA guidelines on this matter. Specific attention is devoted to the most appropriate experimental designs, the size of the volunteer sample, the ethical issues involved, statistics to assess bioequivalence and the accepted standard format for final research reports. Some aspects which create serious problems in bioequivalence trials, most of which not fully covered by the EU and USA specific guidelines, are comprehensively discussed. These include a) drugs with elevated variability; b) endogeneous substances and the management of baseline value; c) modified release formulations; d) prodrugs; e) restrictions to be contained in forthcoming guidelines on chiral medicinal products; f) superbioavailability; g) drugs with elevated half-life and h) cases in which bioequivalence trials should not be needed. As generic drugs cost less than the innovator product, agencies have facilitated their NDA procedures by requiring a dossier on chemistry and pharmacy and a pivotal bioequivalence study to demonstrate that the generic formulation is fully interchangeable with the innovator product. Bioequivalence is thus the key requirement for an NDA of a generic drug, and trials should be planned, conducted and reported in the most appropriate way. With this in mind, this review is an up-to-date reappraisal that should stimulate the attention of scientists and regulatory authorities on some open questions on bioequivalence.

Dosage Forms↗

PubMed1991

Information systems for the analysis of drug prescriptions in Spain.

The Spanish National Health Service, largely represented by INSALUD, covers at present over 98% of the Spanish population. Services are free at the point of delivery with exception of prescription charges. The patients contribution towards the price of their medicines is approximately 40% of the cost of the drug for most ethical preparations. Non-prescription drugs are not reimbursed by the National Health Service. Pensioners and the disabled are exempt from prescription charges. Prescription analysis or monitoring is possible within INSALUD because of the necessity to reimburse pharmacists for the prescriptions they dispense, monthly batches of prescriptions are processed. The Drug Data Bank possesses three databases that may be used for prescription analysis, these are ESPES, ECOM and PACTIV. Information from these databases is used by external workers in: drug Monitoring Centres for Adverse Drug Reactions; the Spanish Collaborative Study on drug-induced birth effects; drug utilization research workers; INSALUD also produces reports on drug prescribing and these have a particular emphasis on expenditure; the General Directorate of Pharmacy also use these databases for their policy making on issues related to, and derived from prescribing.

Adverse Drug Reaction Reporting Systems↗

PubMed1990

An intravenous potassium policy with concurrent physician evaluation.

Hospitals have an ethical, as well as a legal, duty to provide safe care to patients. Responsibility for providing care involving medications is distributed to practitioners within the institution including physicians, nurses, and pharmacists. Each practitioner plays an essential role in the provision of safe intravenous potassium supplementation. A procedure is described which incorporates drug usage evaluation into a safe, simple, intravenous potassium policy.

California↗

PubMed2001

Community pharmacists' experience of over-the-counter medicine misuse in Scotland.

Over the last decade Britain has observed a trend towards the re-regulation of 'prescription only medicines' in favour of pharmacy status drugs. This move towards self-treatment to reduce pressures on general practitioner drug budgets and workloads has focused attention on the need for community pharmacists to extend their patient education and screening roles. In response to these changes, this study was conducted to explore: the type of over-the-counter (OTC) medicine being misused in Scotland; pharmacists' professional attitudes and management of OTC misuse; and the training and support needs of pharmacists. A postal questionnaire was designed. This was informed by an earlier stage of qualitative research and the available literature. It was then piloted and administered to all 110 pharmacies in the study area. A 79% response rate was achieved. The research found that OTC misuse, particularly of certain analgesics, sleeping prescriptions, products containing codeine or pseudoephedrine, caffeine, cough mixtures, and laxatives was common. The estimated mean number of patients suspected of misusing medicines in a typical week was 5.63. Pharmacies in urban areas were more likely than those in rural areas to report suspected misuse. The research identified a number of intervention strategies relating to: patient/pharmacist interaction; information provision; removal of products from the point of sale; sharing of information with other local pharmacists; and referral to other members of the primary care team. Pharmacists expressed a need for support in managing OTC misuse and in organising 'early warning systems' to share information locally.

Ethics, Professional↗

PubMed1992

P & T Committee response to evolving technologies: preparing for the launch of high-tech, high-cost products. Roundtable discussion.

P & T Committees are entering an exciting era in which the introduction of biotechnology-derived pharmaceuticals is providing life-saving opportunities for conditions for which there was little or no hope for a cure. The P & T Committee at Thomas Jefferson University Hospital has anticipated the challenge that these novel therapeutics present, and has already positioned itself for the pending approval of the first therapeutic human monoclonal antibody. Nebacumab (HA-1A, formerly known as Centoxin; by Centocor) will be used for the treatment of gram-negative sepsis. Although this antiendotoxin has a good side effect profile, its use also carries a high price tag. This will raise several difficult ethical issues once the product is introduced. In this exclusive Hospital Formulary roundtable, members of Thomas Jefferson's P & T Committee and Technology Assessment Subcommittee provide their insights for responsibly managing a high-tech, high-cost product such as nebacumab.

Antibodies, Monoclonal↗