Prescription data mining and the protection of patients' interests.

Pharmaceutical companies have exploited health information technology to "mine" data from drug prescriptions and use the data to better target their sales pitches to physicians. This article considers the policy arguments and first amendment implications regarding state regulation of data mining. It concludes that the legislative provisions are desirable and should withstand constitutional challenge.

Desabastecimiento y suministro irregular de medicamentos: problemas urgentes / Shortages and irregular supply of medicines: an urgent problem

Actualmente en el Estado español se están produciendo problemas en el suministro de medicamentos a los serviciosfarmacéuticos. En el presente artículo se revisa la normativa vigente acerca de la distribución de medicamentos.Se comentan además las posibles causas del problema. También se analizan los medios que desarrolla el Estadopara evitar esta problemática y la postura de la Comunidad Valenciana que, de manera pionera, quiere regular enmateria de distribución farmacéutica, mediante una normativa con rango de Ley, para evitar los problemas quese suscitan

In this paper, we discuss the problems arising from the current supply problems of medicines to pharmacy outlets inSpain, as well as a revision of present regulations governing their distribution. In addition to the possible causes, ananalysis of the measures developed by the state to combat these problems has been made, as well as an assessment ofthe impact of new pioneering legislation passed by the regional government of Valencia, aimed at finding a solution

Las enfermedades raras y los medicamentos huérfanos en España: el Grupo de Investigación Terapéutica de Enfermedades Raras (GITER) de la Red epidemiológica para Investigación de Enfermedades Raras (REpIER) / Rare diseases and orphan drugs in Spain. Rare diseases therapeutic research group (GITER) in the REpIER (Epidemiological Newtwork on Rare Diseases Research)

Las enfermedades raras se definen por su baja prevalencia, lo que crea un problema social que ha llevado a diferentes países y a la Unión Europea a promulgar legislación para favorecer la investigación en la materia. En España, se ha creado la Red REpIER, a la que pertenece el Grupo GITER, que está formado por una serie de servicios de farmacia hospitalaria coordinados por un grupo del departamento de Farmacia y Tecnología Farmacéutica de la Universidad de Barcelona, cuya línea de investigación se centra en la recogida de información y análisis de costos de los tratamientos destinados a enfermedades raras. El objetivo de este trabajo es presentar a la colectividad científica y profesionales sanitarios el origen, organización, objetivos y líneas de trabajo que está llevando a cabo el grupo GITER en la Red

Rare Diseases are defined by their low prevalence, creating a social problem that lead different countries and the European Union to promulgate regulations to favour research in the matter. In Spain, REpIER was created with the support of FIS (Fund for Health Research of the Institute of Health Carlos III), including GITER, a group formed by a network of hospitals pharmacists coordinated by a group from the Pharmacy and Pharmaceutical Technology Department of the University of Barcelona with the aim of studying the pharmacological treatments of rare diseases, with special emphasis in the evaluation of their costs. With this paper we aim to present to researchers and health professionals the background, organization, objectives and research lines that the group GITER is implementing in the network REpIER

The case for bar coding: better information, better care--and better business.

Bar coding, pervasive in almost all other industries, has been slow to infiltrate the healthcare setting. for years, disparate systems, a lack of standardization, and an absence of significant market incentives have hindered healthcare providers, IT vendors, and drug manufacturers alike in adopting bar coding technology. But thanks to a proposed FDA rule issued last Spring, bar coding is is edging its way to the top of many IT priority lists. By mid-2004, the final rule should be passed, which will require all drugmakers to bar code prescription drug products at the unit dose level. The bar code will identify the drug, manufacture, strength of the medication, and dosage.

Bar code bandwagon.

The Food and Drug Administration issued a proposed rule in March requiring bar codes on all medications. Most expect that the technology will be commonplace in hospitals before the FDA's three-year window. A handful of systems are leading the way.

Medication errors caused by confusion of drug names.

Many drug names can look or sound like other drug names, which leads to confusion and potentially harmful medication errors. While various types of drug names exist, brand (proprietary) names are most commonly confused. Examples of the numerous drug names that have been confused because they look and/or sound similar include Celebrex (celecoxib), Cerebyx (fosphenytoin), and Celexa (citalopram). Factors such as poor handwriting and clinical similarity may exacerbate the problem. This problem can be alleviated through actions by regulatory agencies, pharmaceutical manufacturers, healthcare professionals, and patients. To address the problem, significant changes in the pharmaceutical regulatory process have occurred in the US and Europe.

Balancing diversion control and medical necessity: the case of prescription drugs with abuse potential.

Narcotics and other prescription drugs play a significant and legitimate role in medical practice. The illicit use of prescribed medicines, however, remains a major problem. This paper examines the effectiveness of two drug diversion control programs, multiple copy prescriptions programs (MCPP) and electronic data transfer (EDT) systems, and their impact on medical practice. Current evidence demonstrates that these programs decrease prescription drug use, with much of the decrease due to declines in inappropriate use. MCPPs appear more effective than EDT in preventing diversion. More research is needed. however, to assess their effects on medical practice, particularly patient quality of care.

A primary care application of an integrated computer-based pharmacy system.

Primary care demands a continuous flow of current pharmaceutical information to the front lines of patient services. With a wide spectrum of drugs to prescribe and a continuous production of new drug-related information, the practicing physician is faced with a social and professional mandate to deliver the most acceptable drug in a safe and efficacious manner. The legal implications of this product and knowledge explosion have exposed the human brain's inability to store, update, and recall what is currently available. Physicians can no longer trust their memory or their paper-based medical record to protect them from potential liability. The tools to correct this mental imbalance are now available and it should be standard practice to implement a sophisticated computer-based pharmacy system (CBPS) for every outpatient in the United States.

Preparing to implement an information system.

The factors that must be considered when preparing to implement a pharmacy information system are discussed. A major early decision is whether to locate the central processing unit (CPU) in the pharmacy department or the information services department. Other site considerations are the size of the CPU, environmental conditions, electrical needs, the presence of a backup CPU, and system security. System considerations include interfaces, daily management, preventive maintenance, other support functions, and printers. The system will affect all personnel in the pharmacy department; most jobs will have to be redesigned. Issues to address during implementation planning are forms and labels, the implementation schedule, benchmark development, system conversion, and problem resolution. Files must be developed with great attention to detail and accuracy, as they are the heart and soul of the system. Most departmental policies and procedures will have to be incorporated into the operations of the system. Other departments--in particular, information services, hospital purchasing, administration, nursing, and laboratory--may have requirements that should be considered. There may be legal requirements in the areas of drug order entry, file security and confidentiality, and retention of records. Extensive preparation and planning are necessary before a pharmacy information system can be implemented.

Prescription drug diversion control and medical practice.

Concern about the role of prescription drug diversion in drug abuse has led to demands for more stringent regulation and for better ways to detect prescription drug diversion. Advances in technology now allow point-of-sale computer systems to report prescriptions filled by pharmacies to state agencies rapidly and possibly more economically. However, the advantages of more comprehensive control systems must be balanced against their possible effects on medical practice and patient care. Our limited knowledge about prescription drug diversion and the impact of diversion control systems on medical practice is summarized. Needed research is outlined together with the components of a diversion control program that balances reducing drug diversion with minimizing adverse effects on medical practice and patient care. We stress the need for broadly defined practice parameters and peer review by medical experts thoroughly familiar with the complexities of medical practice.