Current Status of Expiry of Homeopathic Medicines in Brazil, Germany, India and the United States: A Critical Review.

BACKGROUND: Assignment of expiry date to homeopathic medicines is a subject of important concern to its pharmacists and practitioners. This study compares the regulatory framework for the expiry of homeopathic medicines in four countries: Brazil, Germany, India and the United States. FINDINGS: Different or no expiry periods are variously followed. Whereas Germany, with some exceptions, employs a maximum expiry of 5 years for both potencies and finished products, Brazil adopts a 5-year expiry for finished products only, potencies used in manufacture being exempted from an assigned expiry date. In India, all homeopathic medicines except dilutions and back potencies have a maximum of 5 years' shelf-life, including those supplied to consumers. In the United States, homeopathic medicines are exempted from expiry dates. COMMENTS: There is neither a rational basis nor scientific evidence for assigning a short (3-5 years) expiry period for homeopathic medicines as followed in some of the countries, particularly in light of the fact that some studies have shown homeopathic medications to be effective even after 25 years. Homeopathic ultra-dilutions seem to contain non-material activity that is maintained over time and, since these exhibit different chemical properties compared to the original starting material, it is quite possible they possess properties of longer activity than conventional medicines. Regulators should acknowledge this feature and differentiate expiry of homeopathic medicinal products from that of conventional drugs.

Counterfeit homeopathic medicinal products: syrups. A simple and rapid LC-ESI-MS method to detect preservatives not declared in label.

A rapid and simple LC-ESI-MS method for the simultaneous detection and quantitation of six preservatives in homeopathic syrups has been developed. Counterfeit homeopathic syrups are suspected to contain preservatives that are not declared in label. For this reason a method to ascertain the absence of sorbic and benzoic acids, methyl-, ethyl-, propyl- and butyl-parabens, as the most frequently utilised preservatives, has been developed. Analytes were eluted with a linear gradient of acetonitrile-5mM ammonium acetate in 12 min using 2,4-dichlorobenzylalchol as Internal Standard. The HPLC separation was performed on an Eclipse XDB-C18 (2.1 mm x 50 mm-5 microm) column and the ESI-MS detection was performed in negative ion mode. Linearity of the method was studied in the range of 2 pg to 10 ng injected and correlation coefficients r2 > or =0.9992 were obtained. LOD ranged from 0.04 to 0.4 ng mL(-1).

A critical overview of homeopathy.

Homeopathy is a 200-year-old therapeutic system that uses small doses of various substances to stimulate autoregulatory and self-healing processes. Homeopathy selects substances by matching a patient's symptoms with symptoms produced by these substances in healthy individuals. Medicines are prepared by serial dilution and shaking, which proponents claim imprints information into water. Although many conventional physicians find such notions implausible, homeopathy had a prominent place in 19th-century health care and has recently undergone a worldwide revival. In the United States, patients who seek homeopathic care are more affluent and younger and more often seek treatment for subjective symptoms than those who seek conventional care. Homeopathic remedies were allowed by the 1939 Pure Food and Drug Act and are available over the counter. Some data--both from randomized, controlled trials and laboratory research--show effects from homeopathic remedies that contradict the contemporary rational basis of medicine. Three independent systematic reviews of placebo-controlled trials on homeopathy reported that its effects seem to be more than placebo, and one review found its effects consistent with placebo. There is also evidence from randomized, controlled trials that homeopathy may be effective for the treatment of influenza, allergies, postoperative ileus, and childhood diarrhea. Evidence suggests that homeopathy is ineffective for migraine, delayed-onset muscle soreness, and influenza prevention. There is a lack of conclusive evidence on the effectiveness of homeopathy for most conditions. Homeopathy deserves an open-minded opportunity to demonstrate its value by using evidence-based principles, but it should not be substituted for proven therapies.

The impact of price labeling of muscle relaxants on cost consciousness among anesthesiologists.

STUDY OBJECTIVE: To determine whether placing price labels on the vial caps of muscle relaxants increases cost consciousness among anesthesiologists. DESIGN: Retrospective study. SETTING: University hospital departments of anesthesia and pharmacy. MEASUREMENTS AND MAIN RESULTS: We placed price labels on the vial caps of all muscle relaxants for a study period of 1 year. At the beginning of the investigation, we informed the anesthesiologists of the study, discussed the prices for different muscle relaxants, and encouraged utilizing less expensive muscle relaxants whenever possible without compromising patient care. The price labels on the vial caps served as visual reminders of the various costs of muscle relaxants during daily practice. We compared the total amount spent on each muscle relaxant during the period from October 1993 to September 1994 with the period from October 1994 to September 1995. The total number of surgical cases from October 1993 to September 1994 and from October 1994 to September 1995 was unchanged and equaled 20,389 and 20,358 cases, respectively. Expenditures for pancuronium increased 104.1%. Total expenditure decreased by 12.5%, with a net savings of $47,111. CONCLUSION: Expenditures for the less costly pancuronium increased while expenditures for vecuronium and atracurium decreased. Price labeling of muscle relaxants in conjunction with education reduces total pharmacy expenditure on muscle relaxants.

Understanding homeopathy.

Interest in homeopathy is growing because of the costs and impersonality of modern medical care and the increase in infectious diseases that do not respond to allopathic medicine. Extreme dilutions are the main reason many scientists doubt the effectiveness of homeopathic products. Scientists have petitioned the Food and Drug Administration to hold homeopathic products to the same standards as other drugs. While some studies support the efficacy of homeopathy, controlled clinical studies determining effective levels of dilution for these substances are needed.

Arsenic content of homeopathic medicines.

In order to test the widely held assumption that homeopathic medicines contain negligible quantities of their major ingredients, six such medicines labeled in Latin as containing arsenic were purchased over the counter and by mail order and their arsenic contents measured. Values determined were similar to those expected from label information in only two of six and were markedly at variance in the remaining four. Arsenic was present in notable quantities in two preparations. Most sales personnel interviewed could not identify arsenic as being an ingredient in these preparations and were therefore incapable of warning the general public of possible dangers from ingestion. No such warnings appeared on the labels.

Heavy metal hazards of Asian traditional remedies.

In recent years there has been an increase in the use of traditional Asian medicines. It is estimated that 30% of the US population is currently using some form of homeopathic or alternative therapy at a total cost of over $13 billion annually. Herbal medications are claimed and widely believed to be beneficial; however, there have been reports of acute and chronic intoxications resulting from their use. This study characterizes a random sampling of Asian medicines as to the content of arsenic, mercury, and lead. Traditional herbal remedies were purchased in the USA, Vietnam, and China. The Asian remedies evaluated contained levels of arsenic, lead, and mercury that ranged from toxic (49%) to those exceeding public health guidelines for prevention of illness (74%) when consumed according to the directions given in or on the package. Heavy metals contained in Asian remedies may cause illness of unknown origin and result in the consumption of health care resources that are attributable to other causes. The public health hazards of traditional herbal Asian remedies should be identified and disclosed.

Comprensibilidad de un prospecto de medicamento de venta libre / Comprehensibility of an over-the-counter medicine leaflet

INTRODUCCIÓN: El prospecto que acompaña a los medicamentos de venta libre contiene información importante, que no siempre es comprendida correctamente. OBJETIVOS: Explorar en qué medida se comprende la información incluida en los prospectos de especialidades medicinales de venta libre con paracetamol como principio activo. MÉTODOS: Se realizó un estudio cualitativo, con entrevistas semiestructuradas a 20 adultos a cargo de niños usuarios del medicamento. Se llevó a cabo con un equipo multidisciplinario: dos médicas, una psicóloga, una socióloga y una lingüista. Se utilizó el prospecto de un medicamento con paracetamol destinado a niños mayores de cuatro años. Se analizó cada respuesta como variable dicotómica (sí/no), de acuerdo con la comprensión de la información. Se identificaron las características discursivas de los prospectos y, a partir de ellas, se evaluaron los datos de las entrevistas. RESULTADOS: Ninguno de los entrevistados comprendió la posología, mientras que un 30% tuvo dificultades para entender las contraindicaciones. CONCLUSIONES: Es necesario seguir realizando estudios de comprensibilidad para identificar las dificultades que tienen los usuarios de medicamentos de venta libre para entender los prospecto

INTRODUCTION: Over-the-counter medicine leaflets include important information, which is not alway sunderstood by users. OBJECTIVES: To explore the level of understanding of information stated in over-the-countermedicine leaflets, containing paracetamol as active ingredient. METHODS: A qualitative study was conducted, with semi-structured interviews to 20 adults in charge of children using the medicine. The multidisciplinary team was composed by two physicians, one psychologist, one sociologist and one linguist. It used a leaflet of a medicine containing paracetamol for children older than four years. The study analyzed every response as a yes/no variable according to information comprehension. The leaflet speech features were identified, so as to evaluate the data collected by the interviews. RESULTS: None of the interviewed people understood the dosage, while 30% of them had difficulties regarding contraindications. CONCLUSIONS: It is necessary to perform further comprehensibility studies to identify the difficulties faced by over-the-counter medicine users while reading the leaflets

Guidelines for drug donations

Las donaciones de medicamentos pueden desempeñar un papel esencial en la ayuda tras desastres naturales o como parte de programas de cooperación internacional para el desarrollo. No obstante, cuando son mal manejadas pueden resultar inadecuadas y causar más problemas que los que resuelven. Estas directrices revisadas y actualizadas de la Organización Mundial de la Salud describen las "prácticas de donación adecuadas" que permiten mejorar la calidad de las donaciones de medicamentos. Como base para la elaboración de directrices nacionales o institucionales, pueden ser adaptadas y puestas en práctica por los gobiernos y organizaciones que se ocupan de las donaciones de medicamentos. Las 12 directrices abordan problemas como la selección de los fármacos; la garantía de calidad y la caducidad; la presentación, envasado y etiquetado, y la información y gestión