Propagandas de medicamentos psicoativos: Análise das informações científicas

Objective: According to the World Health Organization, medicinal drug promotion should be reliable, accurate, truthful, informative, balanced, up-to-date and capable of substantiation. The objective of the present study was to review psychoactive drug advertisements to physicians as for information consistency with the related references and accessibility of the cited references. Methods: Data was collected in the city of Araraquara, Southeastern Brazil, in 2005. There were collected and reviewed 152 drug advertisements, a total of 304 references. References were requested directly from pharmaceutical companies' customer services and searched in UNESP (Ibict, Athenas) and BIREME (SciELO, PubMed, free-access indexed journals) library network and CAPES journals. Advertisement statements were checked against references using content analysis. Results: Of all references cited in the advertisements studied, 66.7% were accessed. Of 639 promotional statements identified, 346 (54%) were analyzed. The analysis showed that 67.7% of promotional statements in the advertisements were consistent with their references, while the remaining was either partially consistent or inconsistent. Of the material analyzed, an average 2.5 (1-28) references was cited per advertisement. In the text body, there were identified 639 pieces of information clearly associated with at least one cited reference (average 3.5 pieces of information per advertisement). Conclusion: The study results evidenced difficult access to the references. Messages on efficacy, safety and cost, among others, are not always supported by scientific studies. There is a need for regulation changes and effective monitoring of drug promotional materials.

Análise da prescrição de medicamentos de pacientes hipertensos atendidos pelo SUS da rede municipal de saúde de Rincão - SP

The purpose of this study was to identify the drugs most often prescribed for hypertension at the Municipal Health Care Center of the town of Rincäo, State of São Paulo, Brazil, and the principal interactions arising from their association with other drugs, both anti-hypertensives and those in other classes. The study included 725 hypertensive patients registered at this health care center who were regularly seen by a physician every three months. Data were collected on age, sex, occurrence of diabetes, smoking, sedentary lifestyle and overweight, to obtain a profile of the hypertensive population of the area. Control records of all patients were available at the pharmacy in the health care center, where patients obtained their drugs once a month. Of the 725 patients, 38% were male and 62% female. Most (57%) were between 50 and 70 years of age, 21% used tobacco and 43% led a sedentary lifestyle. Single-drug therapy accounted for 33% of the prescriptions, multidrug therapy for 66%. In addition to anti-hypertensives, 50% of the patients took drugs of other therapeutic classes. Of those receiving multidrug therapy, 34% used three or more anti-hypertensives and 66% used only two of these drugs. Drug interactions were detected in as many as 47% of the prescriptions. Captopril was the drug that showed most interactions with others (54%), followed by hydrochlorothiazide (27%), furosemide (14%), propanolol (4%), and nifedipine (1%). The analysis revealed that drug consumption by the patients investigated is high, with a concomitantly high number of episodes of drug interaction.

Farmacovigilância no Brasil: A relação entre polimorfismo de fármacos, efetividade e segurança dos medicamentos

In spite of the stated Brazilian policy on medicines that their quality, effectiveness and safety should be ensured at reasonable cost, hospitals in the ANVISA Surveillance Network have been receiving notifications of technical complaints, adverse reactions and suspected therapeutic ineffectiveness (STI) of medicines. The purpose of this study was to identify the medicines notified for suspicion of therapeutic ineffectiveness, at a university hospital participating in the national Surveillance Network, and to investigate the existence of polymorphs of any of the drugs involved, by examining the literature. There were 31 notifications of STI in a period of 18 months, concerning 11 different drugs, all of which were 'similar' drugs (neither original nor licensed by originator); five of these could contain polymorphs, according to the literature. However, this does not mean that the other drugs could not contain some unknown polymorphs, more studies being needed on polymorphism, especially in the cases of reported therapeutic ineffectiveness. Therefore, tests of polymorphism should be made part of the routine quality control of the raw materials during the development of medicines and in the studies of pharmaceutical equivalence to 'reference' medicines (innovative brands). The stability test should also involve a study of polymorphism, in order to confirm the solid state stability of the drug. All these measures will assure the effectiveness of medicines, since the reproducibility in the quality of pharmaceutical products could be monitored, as well as the equivalence of each production batch with the batch selected to determine the bioequivalence with the reference brand.

Contribuição do uso de medicamentos para a admissão hospitalar

According to the Word Health Organization, adverse drug reactions (ADR) are any harmful and non intentional answer which occurred in doses normally used in human beings. The ADR can be responsible for 2.4% to 11.5% of hospital admissions. Therefore, this study aimed at knowing the admitted patient's demographic profile due to possible ADR, identifying the most frequent drugs and complaints, and evaluating the incidence of hospital admission related to drug use. Patients who were 18 years old or more and were admitted during a period of one month to a medical clinical of a general hospital were interviewed for one month about drug use before being admitted, as well as regarding to the complaint which led them to hospital. These information were analyzed according to official data, like MICROMEDEX® and WHO criteria as well. It was observed that the admission due to drug use occurred in most part of the cases in elderly [47.5% (66/139)] and women [62% (87/139)]. The most frequent drugs used were: omeprazole (16), analgesics (31), antihypertensive (31), simvastatin (7) and formoterol fumarate (6), and the symptoms were normally associated to the digestive (20.5%), circulatory (20.2%), respiratory (18.2%) and central nervous systems (13.9%). It was estimated that 15.5% (139/897) of the hospital admission occurred possibly due to the drug use. The data found by present study suggests some strategies in order to prevent ADR in the context of primary health care services, such as monitoring drug therapy, manly for patients with chronic diseases, elderly and polimedicated people; and pharmaceutical care including dispensation and purchasing of the drugs, a lot of them dispensed over the counter (OTC).

Apertura económica y desregulación en el mercado de medicamentos

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Análise dos aspectos legais das prescrições de medicamentos

This article describes a survey of prescriptions dispensed in drugstores and pharmacies in the city of Araraquara in the state of São Paulo, Brazil, in May 2006. Their contents were assessed for compliance with the laws in force on drug prescription and dispensing. A total of 1,335 prescriptions were examined: 40 (3%) were unsigned, 212 (15.9%) did not contain the prescribing physician's stamp, 170 (12.7%) were undated. There were prescriptions containing corrections (4.6%), and written in code (4.4%). Only 58.8% were legible and easy to understand; nevertheless all of them were dispensed. Some did not specify the name of the patient (7.2%). On how to use the medication prescribed, not a single prescription contained all the information required by law. Specifically, 7.6% lacked information on dosage, 54.3% on presentation, 33.6% on how to take the drug, and 51.2% on duration of treatment. The data show a general failure to comply with the laws on drug prescription and dispensing. Incomplete information on the drugs and their correct use could lead to irrational use and errors in medication. The lack of prescribers' signature and stamp, date of emission and name of patient can lead to fraudulent and counterfeit prescriptions. Thus, the data found point to the need for capacitation of prescribing and dispensing professionals and the importance of the role of professional associations in guiding their members.

Farmacología en la tercera edad: Medicamentos de uso continuo y peligros de la interacción medicamentosa

Introduction: It was observed a considerable growth of elderly people. They are who use more medicines. The physiological changes associated with the age advancing can make pharmacokinetic and pharmacodynamic alterations. The cognitive decline, physical limitations and associate chronic pathology affect the medications appropriately use ability. Aims: Based in a literature review, appoint the main pharmacological groups prescribed to the elderly and the drug-drug interaction risks. Conclusion: The most of elderly use continually at least 3 medicines, the most prescribed are to cardiovascular and psychic diseases treatment.

Derechos de propiedad intelectual en la agenda de los países en desarrollo. Leyes de propiedad intelectual y acceso a medicamentos

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Enfrentando o futuro da proteção social: acesso, financiamento e solidariedade - Síntese

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Estudo clínico randomizado e aberto para avaliação de eficácia e superioridade dos medicamentos EF028 aerossol, EF028 creme e Andolba® frente ao tratamento controle e comparativo de não inferioridade entre os medicamentos EF028 aerossol, EF028 creme e Andolba® para avaliação de eficácia na redução da sintomatologia dolorosa

Aim: This study aimed to evaluate the efficacy of a new topical drug (EF028) in two separate presentations (aerosol and cream) in a comparative way with the already registered medication, Andolba® (benzocaine, benzoxiquina chloride benzeconio, menthol) and the negative control (hygiene), in the analgesic efficacy after episiotomy wound, reducing the requirement for systemic medication. Methods: 60 patients were voluntary post normal vaginal childbirth with episiotomy, were divided into four groups to comparatively assess the action of the product EF028 (cream and aerosol), Andolba® and soap, the efficacy of decreasing painful symptoms from daily use for 2 times a day for seven days. Clinical assessments and subjective pain occurred daily until the third postoperative day and on the 7th postoperative day. Results: The results showed that the drugs promoted a reduction of painful symptoms and there was no statistically significant difference (p <0.05) between presentations of drug EF028 (cream and aerosol) and Andolba® and the three products were significantly higher (p <0.05) to the control. Conclusions: The evaluated drugs EF028 aerosol, EF028 cream and Andolba® had similar efficacy in relieving the painful symptoms of the perineal region in postoperative episiotomy can be considered as indication for postoperative episiotomies. © Copyright Moreira Jr. Editora.

Estudos de medicamentos biosimilares

In Brazil, the registration of new drugs is carried out only when the regulatory agency (Anvisa, acronym in Portuguese) is fully satisfied with the evidence of their quality, efficacy and safety, presented by a pharmaceutical industry that strive for this registration. With the patent expiration, pharmaceutical companies are attracted to produce biological medicines called biosimilar or biogenerics or simply generics, whose approval may result in reduced treatment costs. But it is necessary that the biosimilar be, at least, equally efective and safe and without contaminants in relation to the original. Recent consensus guidelines aim to establish criteria for efcacy and safety of these medicines. Preclinical studies in vitro and in vivo, the origin of raw materials and clinical studies phase I, II and III are recommended for biosimilar medicine registration in the international market. Low molecular weight heparins are found in this situation. In this review we specifcally addressed this type of medicine, which could serve as a benchmark for other biosimilar medicines.

Notas sobre o acesso aos mercados e a formação de uma Area de Livre-Comércio com os Estados Unidos

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Crédito bancário no Brasil: participação das pequenas empresas e condições de acesso

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