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PubMed1985

Drug use and expenditures in 1982.

This article provides national estimates of drug use and drug expenditures in 1982. Total outpatient drug exposure increased 5% from 1981 to 1982 and 28% from 1971 to 1982. Hydrochlorothiazide was the most frequently dispensed drug chemical and was contained in more than 5% of all 1982 prescriptions. Sixteen major therapeutic classes accounted for about 80% of drugstore and hospital expenditures for ethical pharmaceuticals. Hospitals spent around +3.0 billion and a third of this total was for anti-infectives administered for systemic effects. The prescription drug component of the consumer price index increased 11.7% in 1982, and consumers spent about +14.5 billion on prescriptions from retail pharmacies alone.

Adolescent↗
PubMed2006

Impact of the Konstanz method of dilemma discussion on moral judgment in allied health students: a randomized controlled study.

The objective of the study was to determine the effect of the Konstanz method of moral dilemma discussion (KMDD) on moral judgment in allied health students. The study employed the Moral Judgment Test, translated from English into Thai and validated in 247 students, as an moral judgment instrument. The scale satisfied four validity criteria: preference hierarchy, quasi-simplex structure of stage preference, affective-cognitive parallelism, and positive correlation between education and moral competence score (C-index). Test-retest reliability at a 1-month interval was 0.90. To investigate the impact of the KMDD, 83 pharmacy technician and dental nursing students were asked to participate in the study. The subjects were randomly assigned into control (n = 41) or experimental (n = 42) groups. The experimental group participated in a 90-min KMDD once a week for 6 consecutive weeks. Students in the control group also met once a week for 6 weeks to discuss the topics not related to ethics. All subjects completed the Moral Judgment Test before and after the intervention and again 6 months later. Split-plot ANOVA of the C-indexes at the beginning revealed that the experimental and control groups were not different (20.57 +/- 13.45 and 24.98 +/- 16.12). However, the experimental group scored significantly higher than the control group did after the intervention (35.18 +/- 10.96 and 24.20 +/- 14.70) and 6 months later (33.00 +/- 11.02 and 23.67 +/- 14.35). The KMDD appears to be a practical and effective intervention for developing moral judgment in allied health students. The effect on moral judgment remains at least 6 months after the intervention.

Adolescent↗
PubMedDate not supplied

[Pharmacy Department standard procedures for clinical trial development].

INTRODUCTION: Regulations on good clinical practice in the execution of clinical trials require the establishment and compliance of normalised working procedures by the hospital Pharmacy Department. These procedures must indicate precisely each one of the processes involved in their development, e.g. the reception, custody, storage, preparation and dispensing of research samples. OBJECTIVE: The aim of the present study is to analyse the information included in clinical trial protocols involved in the circulation of drug samples during the research stage and, based on the results obtained, to develop normalised working procedures for our hospital Pharmacy Department in order to carry out these clinical trials. MATERIAL AND METHODS: Eleven items were defined in order to describe key processes involved in identification, storage, receipt, preparation, dispensation, administration, maintenance and return of research samples, as well as those related to the beginning and end or closing of a clinical trial. Information included in 39 clinical trial protocols that had been sent to the Hospital Ethics Committee for evaluation between January and August of 2002 and was analysed in terms of the items previously defined. RESULTS: 46% of the protocols included data from the monitor or person representing the sponsor. 64% adequately described conservation and storage conditions of the research samples; but in 39% of the studied cases external labelling descriptions did not comply with legislation. Only 15% of the cases included clear instructions on research sample reception and its acknowledgement. 25.6% reported correct handling and/or preparation instructions for research samples with parenteral administration. Sample dispensation procedures were correctly described in no more than 5.1% of the protocols analyzed. 41% included information for patients, relatives or nurses on administration and handling of research samples, but none of them included specific information pamphlets or three-page leaflets. Procedures for either returning research samples to the sponsor or for their maintenance and replacement were not specified in the 71.8 and 100% of the cases, respectively. Likewise, trial ending or closing dates as well as procedures that must be followed by the Hospital Pharmacy Department during these processes were not stated in 89.7% of the protocols. Finally, only 30.8% of the cases explicitly cite the hospital Pharmacy Department. CONCLUSION: These results support and justify the need to improve clinical trial protocols in order for them to be performed in a secure, effective and efficient way. Besides, they have been the starting point to devise the normalised working procedures of the hospital Pharmacy Department for the development of the clinical trials.

Clinical Protocols↗
PubMed2003

Relationship of serotonergic antidepressants and need for blood transfusion in orthopedic surgical patients.

BACKGROUND: Several reports of various bleeding problems associated with the use of serotonergic antidepressants have been published. However, no information concerning the effect of these drugs on perioperative blood loss and blood transfusion requirements during orthopedic surgery is available. The objective of this study was to determine the association between use of serotonergic antidepressants and perioperative blood loss and transfusion in orthopedic surgical patients. METHODS: A retrospective follow-up study, using routinely collected hospital and pharmacy data, was conducted among all orthopedic patients undergoing surgery from January 1, 1999, through December 31, 2000. The actual blood transfusion requirements and blood loss during surgery were assessed. Patients were divided into 3 groups for comparison: users of serotonergic antidepressants, users of nonserotonergic antidepressants, and nonusers of antidepressants. The Medical Ethics Committee approved the study protocol, and informed consent was obtained from all patients or their legal relatives. RESULTS: A total of 520 subjects with evaluable data participated in the study. The risk of blood transfusion almost quadrupled for the serotonergic antidepressant group as compared with the nonusers (adjusted odds ratio, 3.71; 95% confidence interval, 1.35-10.18). Patients using nonserotonergic antidepressants had no increased risk (odds ratio, 0.74; 95% confidence interval, 0.10-5.95). CONCLUSIONS: Use of serotonergic antidepressants is associated with an increased risk of bleeding and subsequent need for blood transfusion during orthopedic surgery. The bleeding could be attributed to inhibition of serotonin-mediated platelet activation.

Aged↗
PubMed2004

Multilingualism and healthcare in Nigeria: a management perspective.

Nigeria has a healthcare system that has been described as defective even by its managers. A year 2000 study by the World Health Organization (WHO) of health systems in 191 member countries ranked Nigeria 187th. These several evaluations consistently point to inadequate managerial skills. Regrettably, very little is known of the import of language and communication as management issues in healthcare delivery in this country of 400 languages. This article therefore proposes a language-driven audit of health management in Borno State (northeast Nigeria) as a means of sensitizing policy makers and implementers. Based largely on data from questionnaires completed by 129 health professionals belonging to various professional categories (physicians, nurses, pharmacy staff, laboratory staff, and medical and health workers) and drawn from four hospitals, the study explores the relationship between multilingualism and the following: (a) patients' rights; (b) staff recruitment, deployment and commitment; (c) human asset accounting; (d) physician-population ratio. This language-driven audit reveals a number of points, including: ethically questionable practices; distributional imbalance in personnel; commendable cases of employee commitment; and inequity in renumeration.

Communication Barriers↗
PubMed1998

Training pharmacists and pharmacy assistants in the stage-of-change model of smoking cessation: a randomised controlled trial in Scotland.

OBJECTIVE: To evaluate a training workshop for community pharmacy personnel to improve their counselling in smoking cessation based on the stage-of-change model. DESIGN: A randomised controlled trial of community pharmacies and pharmacy customers. SETTING: All 76 non-city community pharmacies registered in Grampian, Scotland, were invited to participate. Sixty-two pharmacies (82%) were recruited. SUBJECTS: All the intervention pharmacy personnel were invited to attend the training; 40 pharmacists and 54 assistants attended. A total of 492 customers who smoked (224 intervention, 268 controls) were recruited during the 12-month recruitment period (overall recruitment rate 63%). MAIN OUTCOME MEASURES: The perceptions of customers and pharmacy personnel of the pharmacy support and self-reported smoking cessation rates for the two groups of customers at one, four, and nine months. RESULTS: The intervention customer respondents were significantly more likely to have discussed stopping smoking with pharmacy personnel, 85% (113) compared with 62% (99) of the controls (p < 0.001). The former also rated their discussion more highly; 34% (45) of the intervention customers compared with 16% (25) of the controls rated it as "very useful" (p = 0.048). Assuming non-responders had lapsed, one-month point prevalence of abstinence was claimed by 30% of intervention customers and 24% of controls (p = 0.12); four months' continuous abstinence was claimed by 16% of intervention customers and 11% of controls (p = 0.094); and nine months' continuous abstinence was claimed by 12% of intervention customers and 7% of controls (p = 0.089). These trends in outcome were not affected by potential confounders (sex, age, socioeconomic status, nicotine dependence, and type of nicotine replacement product used) or adjustment for clustering. CONCLUSIONS: The intervention was associated with increased and more highly rated counselling, and a trend toward higher smoking cessation rates, indicating that community pharmacy personnel have the potential to make a significant contribution to national smoking cessation targets.

Adolescent↗
PubMed1994

Managing oncology research protocols.

Oncology research protocol management is important for the effective execution of clinical trials with oncology patients. Clinical trials explore investigational drug safety, efficacy, and effectiveness. Investigational drugs have not received approval for widespread use and marketing by the Food and Drug Administration (FDA). The National Cancer Institute (NCI) has several branches concerned with investigational drug procurement, distribution, and recordkeeping of investigational cancer chemotherapy agents. Before an investigational drug is approved by the FDA for marketing in the United States, it must undergo several phases of pre-clinical and clinical trials. The Institutional Review Board (IRB) must review and approve clinical trials to ensure that studies meet legal, ethical, and scientific standards. The principal investigator (PI) takes responsibility for the clinical trial. Informed consent must be obtained from subjects before they may participate in clinical trials. The informed consent form is reviewed by the IRB. The investigational drug storage, accountability, ordering, distribution, and drug information dissemination process is improved with a pharmacy-coordinated investigational drug service.

Clinical Trials as Topic↗
PubMedDate not supplied

Managing the aftermath of medication errors: managed care's role.

OBJECTIVE: To discuss managed care's role in managing an organization's response to a medication error and to provide specific recommendations for that response. DATA SOURCES: Published articles and reports related to crisis management, service failure, public relations, ethics, psychology, management, marketing, health care, and law. Review of the literature on crisis management and service failure was extensive. ProQuest and MEDLINE databases were searched. Search terms were medication error, medical error, and organizational crisis. STUDY SELECTION: Studies were selected on the basis of their relevance to practitioners. DATA SYNTHESIS: Medication errors place practitioners, pharmacies, and health care organizations under severe emotional, physical, and financial stress. Managed poorly, a medication error can have disastrous consequences for all involved. When the response is managed correctly, a medication error presents a challenge, but one that is survivable and potentially instructive. Managed care should develop and disseminate best practices for responding to errors and lead the development and adoption of technologies and systems designed to curtail the number of errors and reduce the costs associated with those errors. Effectively responding to a medication error allows the pharmacy organization to maintain or resume its core activities while minimizing stakeholders' losses. The lessons learned in the process of managing the aftermath of a medication error should be incorporated into ongoing quality improvement programs. CONCLUSION: Based on the literature review and the ideas presented, specific recommendations for responding to catastrophic medication errors are made. Following those recommendations would allow those in the health care system--managed care organizations and individual practitioners--to improve their image and do good at the same time.

Attitude of Health Personnel↗
PubMed2006

Barriers to accepting e-prescribing in the U.S.A.

PURPOSE: With the number of prescriptions rising nationally each year, it is surprising that Web-based technology is not fully embraced in the pharmacy industry as an aid to quality-assuring prescribing processes. Traditional prescription handling is done in a manual fashion with physicians hand-writing prescriptions for the patients during an office visit, giving the patient the responsibility of taking the prescription to a pharmacy or mailing the prescription to a mail order company for fulfillment. Electronic prescribing (e-prescribing) has the ability not only to streamline the prescription writing process, but also to reduce the number of errors that may be incurred with hand-written prescriptions. The purpose of this paper is to investigate these phenomena in the U.S.A. DESIGN/METHODOLOGY/APPROACH: A number of hypotheses were tested using principal-components analysis (PCA) and factor analyses. As a result, a total of 55 fully employed, professional and semi-professional service management and internet users, representing a college-educated and knowledge-based sample derived from the metropolitan section of Pittsburgh, was selected. FINDINGS: The six major constructs generated from the factor loadings in descending order of importance were: profit and risk factors, shipping and handling, saving, customer relationship management (CRM) and ethics, age, and awareness. The dependent variable chosen to be regressed against these major independent factor-based constructs was willingness to purchase prescriptions online. The overall relationship was found to be statistically significant (F = 2.971, p = 0.015) in predicting willingness to use e-prescribing options based on the various independent constructs. However, when testing the various standardized beta coefficients in the linear model, only the factor score-based construct CRM and ethics was found to significantly contribute to predicting the willingness to purchase prescriptions online (t = -3.074, p = 0.003). RESEARCH LIMITATIONS/IMPLICATIONS: Although this study appears to represent the e-prescribing process in the U.S.A., the sample size and region studied are only one slice of the general population. Practical implications - Unfortunately, the adoption of e-prescribing has been difficult to attain owing to numerous barriers throughout the industry. Such acceptance barriers include lack of technology trust, associated system costs, and risk of un-securing patient health and medical information. ORIGINALITY/VALUE: This article documents that increasing numbers of pharmacies today are building their IT-infrastructures to accept electronic prescriptions and it may soon be the preferred method for physicians to write prescriptions. It is with great anticipation that this technology will also enhance the prescription-writing abilities of prescribing physicians globally, giving them electronic access to patient medical records and resources that will assist them in prescribing the correct drug for the patient.

Adolescent↗
PubMed2001

Improving benzodiazepine prescribing for elderly hospital inpatients using audit and multidisciplinary feedback.

BACKGROUND: Benzodiazepines are commonly prescribed for older people. Inappropriate benzodiazepine prescribing may result in serious adverse effects, including confusion and falls. AIMS: To determine the prevalence and appropriateness of benzodiazepine prescribing for elderly inpatients at nine public hospitals in Victoria, Australia, and to assess the impact of multidisciplinary feedback on quality of benzodiazepine prescribing. METHODS: Clearance for the study was obtained from ethics committees of participating hospitals. Medication charts for 1301 patients aged 65 years and over were reviewed to identify patients prescribed a benzodiazepine. Using an evidence-based indicator of prescribing appropriateness, cross-sectional notes-based audits were conducted at three time points (baseline, 4-8 weeks and 6 months). Feedback of baseline audit results was provided to medical, pharmacy and nursing staff at multidisciplinary meetings. Changes in benzodiazepine prescribing over the following 6 months were assessed. RESULTS: At baseline, benzodiazepines were prescribed for 36% of patients, and 20% of prescriptions were appropriate. Four to six weeks after feedback, the proportion of patients prescribed a benzodiazepine had not changed significantly (31%, P = 0.125); however, more prescriptions were appropriate (44%, P < 0.0001). For patients who were using a benzodiazepine prior to admission and had a contraindication, there were more attempts to withdraw or reduce the dose (47% vs 21%, P = 0.002) and more prescriptions were for acceptable indications (7.4% vs 2.6%, P = 0.024). Six months after feedback, appropriateness of prescribing remained improved compared with baseline (50%, P = 0.002). CONCLUSIONS: Benzodiazepines were prescribed for approximately one in three elderly hospital inpatients and a large proportion was inappropriate. A multidisciplinary intervention based on audit and feedback improved prescribing and the impact of the intervention was still evident after 6 months.

Aged↗
PubMed1993

A large private university hospital system. The Johns Hopkins Oncology Center.

Clinical trials are a major commitment for a university-based comprehensive cancer center. In 1992, The Johns Hopkins Hospital registered 3508 new patients with cancer and, from this large population, 2880 patients were entered in clinical trials (many patients participated in more than one protocol). The Oncology Center, one of many departments at Johns Hopkins that conducts clinical research, participates in phase I and II new drug trials, phase III comparative studies, and, increasingly, in epidemiologic and prevention research. This calls for much broader participation by community hospitals and for many more patients who normally would not come to Johns Hopkins for their care. There are more than 100 protocols available from the Eastern Cooperative Oncology Group, but Johns Hopkins may participate in no more than 20 at any given time. Thus, every research facility must be selective about the trials in which it participates, given the finite number of hours, dollars, and resources available to carry out these programs. The institution provides safeguards to protect the interest of the patient. These include review and annual overseeing of the concept, design, and specifics of the proposed study. The pharmacy and nursing staff play an important role in control of chemotherapy distribution and use. Patients and physicians, however, must understand the questions the study is asking and agree that they are worth answering. There are problems in motivation; information; costs to the patient, hospital, insurers, and the physician; the concept of the placebo; and informed consent. Clinical research is the most ethical way to test drugs, radiation therapy, surgical procedures, or other new treatments. The clinical trial must meet rigorous criteria of design, conduct, and analysis. The patient must understand the issues and be a volunteer. We must make every effort to help patients and physicians get information about clinical trials and to participate if they choose.

Baltimore↗
PubMed2005

[General aspects and number of phases of the medication system in four brazilian hospitals].

This study identified and analyzed the medication systems in 04 university hospitals located in Recife, Ribeirão Preto, Goiânia and São Paulo, Brazil, after approval by the Research Ethics Committee and authorization by the hospital directors. Data were collected through a structured interview with one of the professionals in charge of the medication system and non-participant and direct observation during one week. The results indicated the points requiring improvement, such as the use of abbreviations, lack of standardization in medication administration times, lack of updated and complete information about the patient, the pharmacy's not working 24 hours a day in hospitals and others. 66 phases were shown in Hospital A, 58 in B, 70 in C, and 80 in D concerning the medication system. Simplifying the processes by reducing the number of phases is the key to reducing medication errors.

Brazil↗
PubMed1995

[Historical sketch of modern pharmaceutical science and technology (Part 4). Post World War II 50 years].

A short history of the pharmaceutical science and technology, postwar 50 years is divided into nine sections for the purpose of discussion. 1. Japan's postwar rehabilitation, Japanese pharmaceutical industries and newly developed pharmaceutical sciences and technologies. In 1945, the Japanese pharmaceutical industry was reconstructed. Production of penicillin was carried out with the strong support of the U.S. Occupation Forces. New sciences in pharmacy (biochemistry, biopharmacy, pharmacology, microbiology, physical chemistry, etc.) were introduced in this period. 2. Introduction age of foreign new drugs and technology (1951 to 1960s). Japan gained independence in 1951. Japanese pharmaceutical companies imported many new drugs and new pharmaceutical technologies from the U.S.A. and European countries in this period. Then, these companies were reconstruction rapidly. However, consequently Japanese pharmaceutical companies were formed as an imitation industry. 3. Rapid economic growth period for pharmaceutical companies (1956 to 1970s). In this period, many Japanese pharmaceutical companies grew rapidly at an annual rate of 15-20% over a period of 15 years, especially with regard to the production of active vitamin B1 analog drugs and some OTC (public health drugs). Some major companies made large profits, which were used to construct research facilities. 4. Problems for the harmful effects of medicines and its ethical responsibility. In the 1970s, many public toxic and harmful effects of medicines were caused, especially SMON's disease. In this time, many pharmaceutical companies changed to its security got development of ethical drugs. 5. Self development of new drugs and administration of pharmaceutical rules (1970s). During the 1970s, many pharmaceutical laws (GLP, GCP, GMP, GPMSP etc.) were enacted by the Ministry of Health and Welfare. In 1976, the Japanese Pharmaceutical Affairs Law was revised, which set forth standards regarding the efficacy and safety of ethical drugs and re-evaluation of drugs. Many facilities were built for the purpose of ensuring efficacy and safety, as shwon in Table 1. 6. Problems of Intellectual Property and followed the revisionist line of research and development for new ethical drugs. In 1976, Japanese pharmaceutical companies ceased to be an imitation industry, and increased research for the development of new drugs. 7. Pharmaceutical science and technology innovation (After 1985). Many of the pharmaceutical innovations during this period were as follows: 7.1) Technology innovation for evaluation of drug efficacy; 7.2) 1st to 3rd medical diagnostic technology innovations; 7.3) medical analytical methods and spectrometry technologies; 7.4) Computer-aided drug-design technology and drug information technology innovation; and 7.5) Drug delivery system and treatment drugs. 8. Recent research and development of new ethical drugs in Japan (1970 to 1995). Cephalosporine type beta-lactams (cefazolin, cefametazole, furomoxef, cefdinir), new quinolones (norfloxcin, ofloxacin, tosfloxcin), H1-Blockers (famotidine), Ca-antagonists (diltiazem, nicardipine), and other new drugs (pravastatine, taclolimus, leuprine) etc. came onto the market. 9. International Harmonization Age and Review toward 21 century. The rapid development and globalization of the pharmaceutical market has promoted international harmonization and rationalization of pharmaceutical regulatory affairs. In 1990, the Japan Pharmaceutical Manufacturers Association published a report toward 21 century, which described practical plans.

Biotechnology↗
PubMed2001

Research as a visiting doctor in Afghanistan and Cambodia.

This paper describes research I conducted into health care and its difficulties while working as a visiting doctor in two developing countries. The research was conducted in the Departments of Medicine, University Hospital, Jalalabad, Afghanistan, in 1994 and 1995, and Calmette Hospital, Phnom Penh, Cambodia, in 1997 and 1998. In Afghanistan I did an observational study of medical practice and case studies at the Department of Medicine, and a survey of drugs sold in pharmacies in Jalalabad. In Cambodia I surveyed hemoglobin concentrations of medical patients, and did an observational study of medical practice and case studies at Calmette Hospital. I surveyed the body weight of medical patients in relation to drug doses, and used a questionnaire to survey prescribing practices of physicians. Each project was conducted by me alone and was completed within 1-3 months. The support by the hospital was good and there where no ethics committees that had to approve the projects. Only verbal consent from the patients had to be obtained and no national laws or regulations affected the research. Small clinical research projects in developing countries are relatively easy to perform, if conducted by one researcher working in a hospital and not relying on special equipment such as a computer.

Afghanistan↗
PubMed1998

Competition through physician-managed care: the case for capitated multispecialty group practices.

The dominant managed care model in the USA is the individual practice association (IPA), in which physicians in separate practices contract with a health plan. One alternative model, the capitated multispecialty group practice (CMGP), has some distinct advantages: (i) the best randomized trial comparing a health management organization (HMO) with indemnity insurance showed equivalent health outcomes for a prepaid group-practice model HMO, with about a 40% saving in cost, mostly from lower hospital utilization. There is no comparable evidence for IPA-style HMO's; (ii) most managed care plans control costs through 'gatekeeper' primary care physicians or capitated payment. Strong financial disincentives to care, applied to small practices, lead to a significant risk of withholding needed care. Large capitated groups diffuse the risk among hundreds or thousands of physicians; (iii) small practices also lack the financial resources and expertise to develop information systems, continuous quality improvement programs, and other means of improving efficiency. Larger groups can integrate specialty and primary care, laboratory, pharmacy, information technology and other services, to improve quality and cost-effectiveness, while maintaining physician control of the process; (iv) in urban California, HMO enrollment in six large capitated groups increased by 91% from 1990 to 1994. Hospital utilization for these groups was less than half the USA average; (v) because it is self-insured, the CMGP could contract directly with purchasers, eliminating the need for the insurance intermediary. The CGMP offers an ethical, effective alternative that maintains the primacy of the physician in health care: physician-managed care.

California↗
PubMedDate not supplied

Liability and new drug studies. Informed consent and clinical trials at the National Institutes of Health.

The liability risk in carrying out clinical trials can be severely affected if the informed consent process is poorly carried out. A poorly informed patient could prematurely drop out of a costly study. Worse yet, if the patient discovers that information is withheld, the patient could sue the sponsor, physician investigator, or IRB and hold them liable, though this is unlikely for investigational drug studies. These costs can be avoided by making sure the clinical trial is properly carried out according to strict federal regulations. It is also critical that clinicians keep the research participant informed on an ongoing basis. The chain of command is vital: The monitor informs the sponsor, the sponsor in turn informs the investigator, and the investigator in turn informs the patient of any new treatment information that may affect his willingness to stay in the trial. Finally, wherever the clinical trial is conducted, it should conform with the ethical principles outlined in the Declaration of Helsinki or with the latest regulations of that country--whichever guidelines provide the greater protection for the patient.

Clinical Trials as Topic↗