Pharma Websites and "Professionals-Only" Information: The Implications for Patient Trust and Autonomy.

BACKGROUND: Access to information is critical to a patient's valid exercise of autonomy. One increasingly important source of medical information is the Internet. Individuals often turn to drug company ("pharma") websites to look for drug information. OBJECTIVE: The objective of this study was to determine whether there is information on pharma websites that is embargoed: Is there information that is hidden from the patient unless she attests to being a health care provider? We discuss the implications of our findings for health care ethics. METHODS: We reviewed a convenience sample of 40 pharma websites for "professionals-only" areas and determined whether access to those areas was restricted, requiring attestation that the user is a health care professional in the United States. RESULTS: Of the 40 websites reviewed, 38 had information that was labeled for health care professionals-only. Of these, 24 required the user to certify their status as a health care provider before they were able to access this "hidden" information. CONCLUSIONS: Many pharma websites include information in a "professionals-only" section. Of these, the majority require attestation that the user is a health care professional before they can access the information. This leaves patients with two bad choices: (1) not accessing the information or (2) lying about being a health care professional. Both of these outcomes are unacceptable. In the first instance, the patient's access to information is limited, potentially impairing their health and their ability to make reasonable and well-informed decisions. In the second instance, they may be induced to lie in a medical setting. "Teaching" patients to lie may have adverse consequences for the provider-patient relationship.

Nuevas perspectivas en el abordaje de la degeneración macular asociada a la edad / New perspectives in the approach to age-related macular degeneration

La aprobación de aflibercept para el tratamiento de la forma neovascular de degeneración macular asociada a la edad ha abierto la posibilidad de tratar a los pacientes con menos inyecciones dada la bimestralidad de dosificación de aflibercept, así como rescatar pacientes con respuesta subóptima a otros tratamientos antiangiogénicos. El presente manuscrito revisa la evidencia científica existente respecto al tratamiento con aflibercept, tanto en pacientes no tratados previamente como en aquellos con respuesta insatisfactoria a los tratamientos convencionales

The approval of aflibercept for the neovascular form of age-related macular degeneration has opened up the possibility of treating patients with fewer injections, since the drug can be administered once every two months. Aflibercept can also be used as rescue therapy in patients with suboptimal response to other antiangiogenic treatments. The present study reviews the scientific evidence on aflibercept, both in treatment-naïve patients and in those with an unsatisfactory response to conventional treatments

A sequential bioequivalence design with a potential ethical advantage.

This paper introduces a two-stage approach for evaluation of bioequivalence, where, in contrast to the designs of Diane Potvin and co-workers, two stages are mandatory regardless of the data obtained at stage 1. The approach is derived from Potvin's method C. It is shown that under circumstances with relatively high variability and relatively low initial sample size, this method has an advantage over Potvin's approaches in terms of sample sizes while controlling type I error rates at or below 5% with a minute occasional trade-off in power. Ethically and economically, the method may thus be an attractive alternative to the Potvin designs. It is also shown that when using the method introduced here, average total sample sizes are rather independent of initial sample size. Finally, it is shown that when a futility rule in terms of sample size for stage 2 is incorporated into this method, i.e., when a second stage can be abolished due to sample size considerations, there is often an advantage in terms of power or sample size as compared to the previously published methods.

Those famous red pills-Deliberations and hesitations. Ethics of placebo use in therapeutic and research settings.

Placebo fascinates and mystifies. Even with today's medical science we still do not know how and if it works. The use of placebo both in therapy and in research evokes ethical problems that are not easily resolved either. Placebo is intrinsically linked to deception, while veracity is a basic tenet in today's thinking of a doctor-patient relationship. In research ethics placebo, though considered the golden control condition, leads to the question of the therapeutic obligation. This narrative review presents an overview of these ethical questions and offers considerations that are of relevance to daily medical and research practice both in psychiatry and elsewhere.

Interacciones entre fármacos en una oficina de farmacia comunitaria / No disponible

Objetivo: cuantificar, valorar y analizar las interacciones farmacológicas en los pacientes que acuden a una oficina de farmacia.Método: Estudio transversal de un año en una oficina de farmacia de Valencia. Las interacciones se detectaron con el programa BotPlus del Consejo General de Colegios Oficiales de Farmacéuticos.Resultados: El 63,64% de las interacciones se produjeron en mujeres. Más del 63% aparecieron en mayores de 56 años. El 57,94% fueron de tipo farmacodinámico. El 69,16% fueron importantes o potencialmente importantes. El 57,01% afectaban a la seguridad. En un 69,16% se recomendaba un control clínico del paciente. La interacción de antiinflamatorios no esteroideos y diuréticos fue la que apareció con una mayor frecuencia.Conclusiones: Es necesario establecer un plan de actuación con protocolos normalizados de trabajo ante posibles interacciones y con intervenciones en la educación de los pacientes para minimizar la aparición de problemas relacionados con medicamentos(AU)

Objective: To quantify, to value and to analyze the pharmacological interactions in the patients who come to a community pharmacy.Method: Cross-sectional study of one year in a community pharmacy of Valencia. The interactions were detected by the program BotPlus of the General Council of Pharmacists’ Official Colleges.Results: 63,64 % of the interactions took place in women. More than 63 % appeared in major of 56 years. 57,94 % were pharmacodinamic type. 69,16 % were important or potentially important. 57,01 % were concerning the safety. In 69,16 % a clinical control of the patient was recommended. The interaction of anti-inflammatories-non-steroidal and diuretics it was the one that appeared with a major frequency.Conclusions: It is necessary to establish an action plan with standard operating protocols to possible interactions and interventions in the education of patients to minimize the occurrence of drug-related problems(AU)

Características de la prescripción por enfermería en la ciudad de Cali, Colombia / Prescription characteristics given by nurses in the city of Cali, Colombia / Características da prescrição por enfermagem na cidade de Cali, na Colômbia

Objetivo. Describir las labores de prescripción de medicamentos que realizaron los profesionales de enfermería en la ciudad deCali (Colombia) durante el año 2008. Metodología. Se realizó una encuesta a 135 enfermeras que laboran en diferentes tipos de servicios asistenciales o administrativos sobre hábitos de formulación, percepciones sobre su formación, capacidades y necesidades para ejercer la prescripción de medicamentos. Resultados. La prescripción de medicamentos es una práctica frecuente en la mayoría de la población encuestada, sin relación con el trabajo que desempeñan, la formación de postgrado o la experiencia laboral. Para ejercer esta labor, los encuestados consideran que necesitan formación en farmacología más que un respaldo legal; sin embargo, no reconocen esta actividad como parte de las funciones de su profesión. La prescripción de medicamentos por enfermeras se presenta en algunos casos como una función de la institución donde laboran. Conclusión. La prescripción de medicamentos es una práctica que se ejerce entre los enfermeros de la ciudad, y de acuerdo con los resultados presentados, requiere un debate académico, legal y gremial para ser considerada entre el que hacer de la profesión.

Objective. To describe the drug prescription duties held by nursing professionals in the city of Cali (Colombia) during the year of 2008. Methodology. A survey was applied to 135 nurses who work in different kinds of healthcare or administrative services about prescription habits, perceptions about their education, abilities and necessities to prescribe drugs. Results. Drug prescription is a frequent practice in most of the surveyed population, unrealeted to the work performed, the postgraduate degree or the job experience. The surveyed consider they need more than a legal support the pharmacological training to prescribe drugs; however they don’t recognize this practice as part of their professional job. Nurses’ drug prescription is sometimes presented as part of their occupation tasks into the institution. Conclusion. Drug prescription is a practice performed by the city nurses and according to the presented results they require an academic, legal, professional debate to be considered between their tasks.

Objetivo. Descrever os labores de prescrição de medicamentos que realizaram os profissionais de enfermgem na cidade de Cali (Colômbia) durante o ano 2008. Metodologia. Realizou-se uma enquete a 135 enfermeirasque laboram em diferentes tipos de serviços assistenciais ou administrativos sobre hábitos de formulação, percepções sobre sua formação, capacidades e necessidades para exercer a prescrição de medicamentos. Resultados. A prescrição de medicamentos é uma prática frequente na maioria da população interrogada, sem relação com o trabalho que desempenham, a formação de pós-graduação ou a experiência trabalhista. Para exercer este labor, os interrogados consideram que precisam formação em farmacologia mais do que um respaldo legal; no entanto, não reconhecem esta atividade como parte das funções de sua profissão. A prescrição de medicamentos por enfermeiras se apresenta em alguns casos como uma função da instituição onde laboram. Conclusão. a prescrição de medicamentos é uma prática que se exerce entre os enfermeiros da cidade, e de acordo com os resultados apresentados, requer um debate acadêmico, legal e do grêmio para ser considerada entre o afazer da profissão.

Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative.

BACKGROUND: The Newborn Drug Development Initiative (NDDI) was established to address the lack of substantive data supporting efficacy and safety of drugs in the neonate. OBJECTIVE: This commentary summarizes some of the ethical issues involved in neonatal drug development. METHODS: At the NDDI workshop held March 29 and 30, 2004, in Baltimore, Maryland, members of the Ethics Group were dispersed among the subspecialty groups before convening to discuss common ethical themes. The Ethics Group then met together to identify and discuss those ethical themes that were both important and shared among the groups. These themes are discussed and illustrated with the other NDDI group reports. This workshop was cosponsored by the National Institute of Child Health and Human Development and the US Food and Drug Administration. RESULTS: Neonatal drug research is scientifically and ethically necessary to establish the efficacy and safety of drugs widely used in newborn medicine. However, research involving neonates must be carefully designed to balance potential risks and benefits, with consideration given to the component analysis of risk. The protocols proposed by the NDDI groups would be considered greater than minimal risk and offering prospect for direct benefit, thus adhering to the Department of Health and Human Services' pediatric research regulations (Subpart D). The NDDI groups all proposed randomized controlled clinical trials, with careful attention to scientifically and ethically appropriate control groups. Multiple regulatory bodies have affirmed that in the absence of proven effective treatment or when a proven treatment offers marginal benefits, study designs with placebo controls are ethical. Obtaining parental permission is a complex issue, with a paucity of evidence describing the feasibility of informed and voluntary consent under conditions of duress and a short therapeutic window. The Subpart D regulations offer sufficient protection to critically ill neonates. The application of the revised Subpart B regulations would restrict the use of a waiver of consent for minimal risk research and for emergency research, and would not allow research that offers no direct benefit and no more than a minor increase over minimal risk. CONCLUSIONS: Multisite collaboration involving standards of care and institutional review board procedures may be important for establishing scientific and ethical consistency. Ongoing dialogue among researchers, clinicians, parents, and other interested parties is essential to promoting ethically and scientifically sound neonatal clinical research.

Ethical issues in funding orphan drug research and development.

This essay outlines the moral dilemma of funding orphan drug research and development. To date, ethical aspects of priority setting for research funding have not been an issue of discussion in the bioethics debate. Conflicting moral obligations of beneficence and distributive justice appear to demand very different levels of funding for orphan drug research. The two types of orphan disease, rare diseases and tropical diseases, however, present very different ethical challenges to questions about allocation of research funds. The dilemma is analysed considering utilitarian and rights based theories of justice and moral obligations of non-abandonment and a professional obligation to advance medical science. The limitations of standard economic evaluation tools and other priority setting tools used to inform health policy decision makers on research funding decisions are outlined.

Public drug procurement: the lessons from a drug tender in a teaching hospital of a transition country.

INTRODUCTION: There are scarce descriptions of hospital drug procurement in the primary literature. The aim of this study was to analyse the drug tender led by a clinical pharmacologist in a 1200-bed university hospital in Serbia, a developing country in socio-economic transition, and to give recommendations for future steps in hospital drug policy. PROCEDURE AND OUTCOMES: Drug tendering was conducted according to the public procurement law from January to April 2003. Analysis included the method of defined daily doses and anatomical therapeutic chemical classification, as well as minimal tender prices, free market prices, essential drugs and domestic and foreign manufacturers. The drug tender list consisted of 548 products, 1,315,501 pharmaceutical units and 312 drug entities, among which 164 were essential. For purchasing purposes, 479 drug formulations were selected, costing approximately 1.4 million Euros (approximately 10% of hospital budget). Three-quarters of the expenditure consisted of antimicrobials (29.1%), cytotoxics (28.8%) and intravenous infusions (17.7%). The top 20 drugs consumed 62.2% of the total drug expenditure. Competition for the most expensive and/or most used drugs was the key for financial success of applicants, even when they offered a limited number of drugs. The tender achieved 4.6% and 17.2% cost savings in comparison with minimal tender price and free-market price, respectively. The tender did not provide a fair balance between domestic and foreign manufacturers. CONCLUSION: The drug tender is resource-consuming, laborious, and risky job. Aggregation of individual tenders, on a national level and/or regional ones, is probably the best choice for hospitals in transition countries at this time.

Clinical pharmacology studies in UK Phase 1 units: an AHPPI survey 1999-2000.

AIMS: This study, conducted by the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI), was designed to determine the amount of Phase 1 activity in the UK in the period 1999-2000, the timelines involved for submissions to ethics committee and responses from ethics committees. METHODS: A questionnaire was completed by AHIPPI members from pharmaceutical companies with in-house phase 1 units, by Clinical Research Organizations (CRO's) and by academic centres. A few responses were also vailable from organisations that were not AHPPI members. Results were rendered anonymous and grouped by category. RESULTS: The response rate was > 98% and indicated that the vast majority of early drug research in humans is now CRO-based (82%). The total number of studies (as indicated by protocol numbers) was notably similar across the 2 years--629 in 1999 and 606 in 2000. Turnaround time for ethics committee review was a mean of 14 days. CONCLUSIONS: These data set important benchmarks for early-phase drug research in the UK where regulatory approval is not currently required. Furthermore, the information should be used as a guide if the competitive nature of such work in the UK is to be maintained as new national legislation is implemented following publication of the European Union (EU) Clinical Trials Directive.

Good clinical practice: a nuisance, a help or a necessity for clinical pharmacology?

This article reviews the impact of good clinical practice (GCP) on clinical pharmacology with particular reference to the new European Union Clinical Trial Directive. The Directive will be applied to both commercial and noncommercial studies on medicinal products for human use. The Directive requires that GCP should be used in all clinical trials except noninterventional studies. GCP is likely to follow the International Conference on Harmonization GCP guidelines in many aspects. GCP will enforce tighter guidelines on ethical aspects of a clinical study. Higher standards will be required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities including computers. Quality assurance and inspections will ensure that these standards are achieved. The additional requirements of GCP are discussed and any advantage to the study subject. The impact of the new Directive within the Research Governance Framework of the UK Department of Health is reviewed.

Screening for human immunodeficiency virus: a survey of British clinical pharmacology units.

1. A survey of screening practices used to detect infection with the human immunodeficiency virus (HIV), covering the 12 months from June 1990 to May 1991, was carried out in 74 clinical pharmacology units performing phase I and II studies. Forty-five units were identified from the Technomark commercial register, and 29 units were identified from the clinical academic membership of the British Pharmacological Society. 2. An overall response rate of 92% was obtained: 41 replies from commercial units; 27 replies from academic units. Seventeen commercial units and 26 academic units reported involvement with healthy volunteer studies; these were the 43 questionnaires analysed. 3. The majority of clinical pharmacology units did not believe that it was necessary to perform HIV screening by HIV antibody testing. Six commercial units (35%) and three academic units (12%) did perform HIV antibody testing in healthy volunteers. 4. Reasons frequently given for testing were protection of clinical and laboratory staff, and the advantages to the volunteer of prophylaxis and treatment at an early stage of HIV infection. Reasons for not testing included the perceived low risk of a positive test, a lack of benefit from treatment, and the adverse implications in relation to health insurance. Advice from an Ethics Review Committee was not generally a reason for testing. 5. In future, screening patterns may change, depending on prevalence of HIV positivity in the community, the benefits of diagnosis and treatment, and the perceived or real disadvantages of having an HIV antibody test. For the present, we believe that indirect methods, such as an HIV risks questionnaire, are more appropriate than direct antibody testing.