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PubMed2001

Italian drug information centres: benchmark report.

OBJECTIVE: Pharmacist-operated Drug Information Centres (DICs) in Italy were surveyed to gather current information concerning the status, availability and scope of their services. METHODS: 40 DICs were identified and a questionnaire was mailed to them. Topics covered in the questionnaire included staffing, resources, activities and services. The results were compared with previous survey results to identify trends. RESULTS: Information from 36 DICs was analysed (response rate = 90%). Almost all regions of the country are represented. Pharmacists, part-time or full-time, are the most frequent employees working in the DICs. 91% of DICs participate in the P/T committee, 74% takes part in the technical scientific committee for clinical experimentation and/or to the Medical Ethics committee and 60% participate in the hospital infection committee. 90% of DICs produce newsletters and/or bulletins and are involved in research projects. Regarding the question-answer service, requests are mainly concerned with clinical comparative efficacy, therapeutic use, adverse effects. The most frequent users are physicians (67%) followed by pharmacists (16%) while other professionals use DICs to lesser extent. The most frequently used information sources, include "Goodman and Gilman's the pharmacological basis of therapeutics", Martindale: the Extra Pharmacopeia and Physician's Desk Reference; journals such as the Medical Letter, Adverse Drug Reactions Bulletin and Drug and Therapeutic Bulletin, Micromedex, Medline and IOWA databases. Data collected through the questionnaire and details about organisation and activity of Italian DICs are available in "Eupharma", the web-site of the Italian Society of Hospital Pharmacy (SIFO) at the URL http://www.sifo.it. CONCLUSION: The results parallel the European and American trends. In future communication and collaboration at European level could help to identify best practice models that would result in the standardisation of the activities and in the harmonisation of programs in common areas of interest.

Data Collection↗

PubMed2000

Evolution of a policy disallowing the use of alternative therapies in a health system.

The evolution of a policy disallowing patients' use of alternative therapies in a health system is described. The pharmacy and therapeutics (P&T) committee at Children's Hospital of Michigan, a part of the Detroit Medical Center (DMC), was asked to review the appropriateness of allowing inpatients to bring in and use alternative therapy products during their hospitalization. Recognizing the interest of consumers in alternative medicines and patients' growing involvement in their own care, the committee drafted a policy that allowed patients to continue taking dietary supplements after being admitted to the hospital. If the physician had no concerns about potential toxicities or drug interactions for a particular product, he or she would write a medication order allowing it to be used. Purchasing and administering the products were deemed the responsibility of the patient or the family. However, many issues concerning supplements remained unresolved, including questions about safety, efficacy, dosing, drug interactions, ethical conflicts, and liability. Ultimately, the P&T committee decided that the potential risks associated with alternative therapies outweighed potential benefits and adopted a policy disallowing the use of alternative therapies by hospitalized patients. The policy was eventually implemented at all eight DMC hospitals. A health system responded to patients' desire to continue their use of alternative therapies during hospitalization by drafting a policy allowing such use. However, concerns related to safety, efficacy, ethics, and liability led to the abandonment of the liberal policy and implementation of a highly restrictive one.

Child↗

PubMed2003

A longitudinal study of United Kingdom pharmacists' misdemeanours--trials, tribulations and trends.

BACKGROUND: Standards of UK pharmacy practice are maintained by the Royal Pharmaceutical Society of Great Britain, which has the power to take a range of sanctions, including removal of the right to practice, against those found guilty of malpractice. This function is currently under review. OBJECTIVE: To conduct a longitudinal study in order to define trends and identify areas where remedial or preventative support could be focused. METHOD: Case analysis of reports of individuals' misdemeanours published in the British Pharmaceutical Journal over a 12-year period (September 1988-October 2000). Professional and personal misdemeanours were considered. MAIN OUTCOME MEASURE: Nature of misdemeanour, conviction or disciplinary proceedings against individual, practising pharmacists in the study period. Reasons offered for committing the misdemeanour and penalties applied. RESULTS: 344 cases, involving a wide range of personal (162) and professional (590) misdemeanours were found. On an annual basis, the maximum incidence of pharmacists found guilty of any misdemeanour was extremely low (< 0.1 of 1% on the pharmaceutical register). The most common professional misdemeanour was failure to keep adequate written records. The most common personal misdemeanour was fraud. The most common reason cited for committing any misdemeanour was financial gain. Numbers in individual offence categories were persistent but low and there were few obvious trends with time. The odds of involvement ratio for male versus female pharmacists was 7.36 (CI: 5.23-10.35) and for ethnic minority versus Caucasian pharmacists was 3.8 (CI: 3.06-4.72). The most stringent penalties (either imprisonment or removal of the right to practice and frequently both) were applied to cases involving personal use or trafficking of drugs subject to abuse. CONCLUSIONS: The current self-regulation of pharmacy practice in the UK involves a wide range of misdemeanours of varying severity; but the incidence of reports of pharmacists found guilty of malpractice was extremely low. The nature of misdemeanours appeared to change little over the period of the study; this study therefore indicates the spectrum of misdemeanours likely to be encountered by a regulating board in the immediate to medium-term future. If regulatory changes such as competence-based practice rights are introduced, the spectrum may change.

Codes of Ethics↗

PubMed1997

The quality of health care in prison: results of a year's programme of semistructured inspections.

OBJECTIVES: To assess, as part of wider inspections by HM Inspectorate of Prisons, the extent and quality of health care in prisons in England and Wales. DESIGN: Inspections based on a set of "expectations" derived mainly from existing healthcare quality standards published by the prison service and existing ethical guidelines; questionnaire survey of prisoners. SUBJECTS: 19 prisons in England and Wales, 1996-7. MAIN OUTCOME MEASURES: Appraisals of needs assessment and the commissioning and delivery of health care against the inspectorate's expectations. RESULTS: The quality of health care varied greatly. A few prisons provided health care broadly equivalent to NHS care, but in many the health care was of low quality, some doctors were not adequately trained to do the work they faced, and some care failed to meet proper ethical standards. Little professional support was available to healthcare staff. CONCLUSIONS: The current policy for improving health care in prisons is not likely to achieve its objectives and is potentially wasteful. The prison service needs to recognise that expertise in the commissioning and delivery of health care is overwhelming based in the NHS. The current review of the provision of health care in prisons offers an opportunity to ensure that prisoners are not excluded from high quality health care.

Budgets↗

PubMed1997

Dental caries and sugar-containing liquid medicines for children in New Zealand.

Children who are taking long-term sugar-containing liquid medicines have an increased risk of developing dental caries. A recent survey of paediatric liquid medicines in New Zealand revealed that over half of the prescribed and over-the-counter (OTC) medicines for children contain sugar. Only one-third of the sugar-free medicines were labelled as such, and only one-quarter were stated to be sugar-free in the New Ethicals Catalogue. Recommendations for limiting caries in these children include: where possible, taking the medicine in tablet form; brushing with toothpaste or chewing sugar-free gum after taking the medicine; home and dental-office fluoride applications; where possible, taking medicines at meal-times rather than between meals; avoiding ingestion of the medicine before bed; and seeking regular preventive dental care. Awareness of the danger posed by these medications should be promoted among prescribers, pharmacists, manufacturers, regulatory authorities, and the public in order to bring about increased availability and use of sugar-free liquid medicines.

Administration, Oral↗

PubMed1985

Career management: understanding the process.

This article is the first of a three-part series on career management for hospital pharmacists. Work attitudes, life cycles, needs, and career trends are discussed. Three basic work attitudes exist. Some see work as punishment. Others believe work in itself is good, i.e., they have a strong work ethic. Some view work as a means to satisfy, at least partially, a range of needs. Attitudinal transition points are likely to occur at specific times in the adult life cycle. The stages of the life cycle can be labeled as leaving, reaching out, questioning, midlife crisis, settling down, and mellowing. A progression through each of these stages is required for normal adult psychological development. Every individual exhibits a blend of needs that changes throughout life. Jobs can fulfill existence, relatedness, and growth needs. Relatedness needs include the need for love, affiliation, social esteem, and power, and growth needs include the need for self-esteem, competence, achievement, and autonomy. Three important career trends are the changing opportunities for advancement, women in careers, and dual-career couples. The number of women pharmacists is increasing as is the number of two-career couples. Tips for managing two-career relationships are presented. Pharmacists can manage their careers more effectively by understanding their needs, identifying their basic attitude toward work, and being aware of the trends occurring in pharmacy.

Attitude of Health Personnel↗

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↗

PubMedDate not supplied

[Monitoring of clinical trials and interim analysis. 1. Monitoring committee].

In order to fulfil the ethical principles linked to the protection of patients randomized in a controlled clinical trial, monitoring procedures need to be set up. In this context, a committee of experts, called the data monitoring committee is in charge of reviewing regularly unblinded data to assess the quality and the relevance of the trial, to evaluate the evidence of an emerging treatment difference and to control the rate of occurrence of serious adverse events. After each meeting, the monitoring committee reports to the steering committee its recommendation to continue or to stop the trial prematurely. Protocol modifications might be proposed as well. Illustrated with several examples, this article reviews different situations a monitoring committee might have to tackle with.

Clinical Protocols↗

PubMed1999

Developing an emergency department team for treatment of stroke with recombinant tissue plasminogen activator.

The EMS, ED, neurology, radiology, nursing, laboratory, and pharmacy departments are integral parts of the stroke team system. These are the key departments responsible for the support of the stroke team, or nucleus, which emanates from the departments of neurology and emergency medicine in the author's medical center. In the same way that cardiac victims are treated for "heart attack," so stroke victims should be treated for "brain attack." The emphasis on public awareness to community outreach and senior citizens groups through the aid of the public affairs department of the institution, the American Heart Association, and the National Stroke Association (NSA) has been a tremendous lift in this, the decade of the brain. The Public Broadcasting System and other television channels have helped enormously in publicizing stroke signs and symptoms, new treatment of stroke, and concurrent risk factors. New clinical research for thrombolytics and neuro-protective agents are now in progress to determine the best treatment for the damaged brain. The emphasis is changing: Time is brain. We hope to change the expenditure attributable to rehabilitation and managed care after stroke to the more hopeful prospects of prevention, early treatment, and fast recovery. We can then see that our friends and family members, as victims of stroke, may proceed to independence rather than long-term care facilities or nursing homes. This will be possible only if hospitals and medical centers nationwide adequately gear themselves for the treatment of ischemic stroke through the creation of a core stroke team, finely-honed interdepartmental cooperation, and the development of an efficient ED team that is fully immersed in the ethics and protocol of "brain attack."

Aged↗

PubMed1992

Drug retailer training: experiences from Nepal.

Sale of modern medicines by untrained peddlers, general merchants, and other drug sellers is common throughout the developing world. Drug sellers operating in the 'informal sector' are often the first source of health care outside the home. Reasons given by patients for using private drug sellers include expediency, convenience, efficacy of the medicines, dependability of supply, and reasonable cost. At the same time, self-medication through private drug sellers can be ineffective, wasteful, and at times distinctly harmful. Regulatory approaches to controlling drug selling in the informal sector, widely endorsed on paper through national drug control legislation, require a cadre of professional regulatory staff and enforcement mechanisms which are too often beyond the current economic and political reach of countries. In Nepal, where rugged terrain has limited infrastructure development, the doctor to population ratio is 1:23,000, utilization of government health services averages only 0.2 visits per person per year. Retail drug outlets outnumber health posts and health centers by a ratio of 4:1 and private drug sellers often offer the only access to modern medicine for much of the population. Community surveys have found that drug retailers are very often the first and only source of health care outside the home. Given the importance of retail drug outlets and the lack of trained pharmacists, the Department of Drug Administration in 1981 established a 45-hr course for drug retailers which emphasized practical training as well as formal teaching on pharmacology, ethics, storage of drugs, and legal issues. By the end of 1989, 4096 drug retailers had graduated from the course. Still run by the Ministry of Health Department of Drug Administration, the course has proven to be administratively feasible and has been quite popular with drug retailers. Initial reservations expressed by doctors and some pharmacists were soon overcome, and the course is now well accepted by professional groups. Because the course is offered in different locations, geographic coverage has also been very good despite Nepal's logistic constraints. The operating cost of the course averages about U.S. $18 per trainee. Informal evaluations have resulted in plans for refresher training more narrowly focused on safe dispensing and appropriate referral for a limited number of important public health problems. Since 50-90% of pharmaceutical expenditures typically pass through the informal private sector in developing countries, it is suggested that other countries consider focused drug retailer training as a response to the problems of manpower shortages and drug dispensing by unqualified staff.

Costs and Cost Analysis↗

PubMed2006

Prenatal genetic testing kits sold at your local pharmacy: promoting autonomy or promoting confusion?

Research groups around the world are developing non-invasive methods of prenatal genetic diagnosis, in which foetal cells are obtained by maternal blood test. Meanwhile, an increasing number of genetic tests are sold directly to the public. I extrapolate from these developments to consider a scenario in which PNGD self-testing kits are sold directly to the public. Given the opposition to over-the-counter genetic tests and the continuing controversy surrounding PNGD, it is reasonable to expect objections to PNGD self-testing kits. I focus on one potential objection, that PNGD self-testing kits would undermine the autonomy of potential test subjects. More specifically, that 'direct to the public' PNGD would fail to ensure that consumers exercise authority in the following PNGD-related choices: Should I use PNGD? Based on the results of the PNGD test, should I continue or terminate my pregnancy? Under the current system, PNGD is provided by health care practitioners, who are required to counsel women both before and after the test. In contrast, 'direct to the public' PNGD would allow women to make their PNGD-related decisions outside the context of the health care system. I compare these two decision-making contexts, arguing that the health care system is not unequivocally better at promoting the autonomy of potential test subjects. Therefore the promotion of autonomy does not constitute a strong argument against such test kits. Other objections may be more persuasive, so I do not offer an overall assessment of the acceptability of 'direct to the public' PNGD.

Abortion, Eugenic↗

PubMed2004

The influence of risk and monetary payment on the research participation decision making process.

OBJECTIVES: To determine the effects of risk and payment on subjects' willingness to participate, and to examine how payment influences subjects' potential behaviours and risk evaluations. METHODS: A 3 (level of risk) x 3 (level of monetary payment), between subjects, completely randomised factorial design was used. Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study, and completed a questionnaire. Risk level was manipulated using recruitment notices and informed consent documents from hypothetical biomedical research projects. Payment levels were determined using the payment models evaluated by Dickert and Grady as a guide. Five dependent variables were assessed in the questionnaire: willingness to participate, willingness to participate with no payment, propensity to neglect to tell about restricted activities, propensity to neglect to tell about negative effects, and risk rating. RESULTS: Monetary payment had positive effects on respondents' willingness to participate in research, regardless of the level of risk. However, higher monetary payments did not appear to blind respondents to the risks of a study. Payment had some influence on respondents' potential behaviours regarding concealing information about restricted activities. However, payment did not appear to have a significant effect on respondents' propensity to neglect to tell researchers about negative effects. CONCLUSIONS: Monetary payments appear to do what they are intended to do: make subjects more willing to participate in research. Concerns about payments blinding subjects to risks could not be substantiated in the present study. However, the findings do raise other concerns--notably the potential for payments to diminish the integrity of a study's findings. Future research is critical to make sound decisions about the payment of research subjects.

Analysis of Variance↗

PubMed1993

Therapeutic uses of gastrointestinal peptides.

The GI tract is one of nature's great pharmacies. Most, if not all, biologically active peptides can be found there, and it is quite likely that others remain to be discovered. Our ability to exploit this resource has expanded considerably over the past two decades. Advances in analytical techniques have allowed investigators to rapidly isolate and purify new compounds from tissue extracts. Sequencing and de novo synthesis of newly discovered peptides are now routine, and the structural modifications required to alter activity and tailor a compound to a particular use are easily made. A number of gastrointestinal peptides or their analogues for use in clinical studies are available from commercial sources (see Table 7). Somatostatin is the first gut peptide to successfully complete development and yield a pharmaceutical compound with a broad range of action. Several of the peptides discussed in this article have similar potential. TRH stands out as a candidate because of its effectiveness in the treatment of experimental spinal cord injury and a variety of shock states. Such a broad range of action in critical fields may justify the intensive development required to yield potent, long-acting, and highly specific analogues. Similarly, the antimetastatic and immunostimulant properties of the enkephalins offer promise for new therapies in the treatment of AIDS, ARC, and cancer. Studies with amylin may lead to new and more precise regimens of blood sugar control in insulin-dependent diabetics and could in turn, prevent some of the worst long-term effects of the disease. The development of effective intranasal forms of GHRH could spare children with GH-GHRH deficiency the distress of repeated injections and help to prevent excessive GH blood levels. Secretin, glucagon, or CGRP might be used one day in cardiovascular emergencies, and VIP or its analogues could prove effective in the treatment of asthma. Although preliminary results with many of these peptides are encouraging, further progress will require the development of standardized experimental models and a more rigorous approach to experimental design. Many of the studies reported here suffered from small patient numbers, a narrow or nonexistent range of doses, or the use of only one or two dosing regimens. Lack of objective criteria for determining the level of response, e.g., in studies of mental illness or degenerative diseases, and the ethical problems of withholding treatment from some patients to establish proper controls further hamper research in this area. If the questions of efficacy and safety are to be resolved, thorough, well-planned trials will be required.

Amino Acid Sequence↗