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).

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.

Acesso a medicamentos essenciais em farmácias e drogarias do Município de Araraquara

A survey to determine the availability of 20 essential medicines for the diseases with highest prevalence in primary health care was conducted in the city of Araraquara. The presence and the price of these medicines in private sector pharmacies and drugstores of the city were recorded. Two forms, recommended by the WHO, were used in the survey, one for availability and the other for prices. The drugs most commonly available in pharmacies and drugstores were: propranolol (90.5%), captopril (96%) and ranitidine (96%), while the least available were ferrous sulfate (27%), beclomethasone (33.8%) and ibuprofen (41.9%). The drugs that showed the greatest variation among the prices charged were: propranolol (97.1%), hydrochlorothiazide (96.4%) and glibenclamide (95.0%), while the least variable were salbutamol (30.8%) and trimethoprim-sulfamethoxazole (30.2%). Generic drugs, which were half (10) of those assessed, had the lowest prices. The indicators of access, referring to the ability of patients to acquire drugs for the treatment of major diseases at the primary health care level, showed that no establishment stocked all 20 essential drugs and that wide variations existed in their prices, undermining their availability to drug users, whose only sources are pharmacies and drugstores. These data demonstrate the importance of the popular pharmacy to improve the access to medicines, by lowering the cost and increasing the availability of the items selected for the National List of Essential Drugs (RENAME).

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.

Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula

With recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study of dissolution profiles are gaining more and more importance. Though introduced initially as a way of characterizing the release profile of poorly soluble drugs, dissolution tests are currently part of pharmacopoeial monographs on almost all the oral solid pharmaceutical forms. The objective of this study was to determine the dissolution profile (percent drug dissolved versus time) of the pioneer brand, generic and similar pharmaceutical capsules containing 500mg cephalexin. Three pharmaceutical brands (reference, generic and similar) were subjected to the dissolution test and in vitro dissolution profiles were recorded. From the results of the dissolution test, it was concluded that the samples met the acceptance criterion, as no difference was observed in the percentage of the drug dissolved in a standard time. The dissolution profile indicated that this medicine, in this pharmaceutical form, dissolves readily (85% of the drug dissolved in 15 minutes) and the curves showed great similarity, suggesting that the 3 brands are pharmaceutically equivalent.

Atributos físicos do solo em diferentes condições de cobertura vegetal em área de plantio direto

The use of cover crops in the soil causes changes in soil attributes influencing in a series of hydro-physical processes, which also modify the ability of soil to support the many activities that it is intended. Thus, the objective of this study was to evaluate the effect of cover crops on physical attributes of the soil. For this, an experiment was carried out on a Typic Hapludox, Jaboticabal State, Brazil, using cover crops of millet, sunn hemp, jack bean, lab-lab and black velvet bean in no-tillage and fallow area (spontaneous vegetation). The characteristics evaluated were the bulk density, macroporosity, microporosity, total porosity, aggregate stability, penetration resistance and organic matter. The incorporation of cover crops has proved to be a beneficial practice for the physical attributes of the soil, allowing a greater aggregate stability compared to fallow in the depth of 0-0.05 m. All cover crops presented values of soil penetration resistance below the critical value of 2 MPa.

Polimorfismo na produção de medicamentos

Polymorphism can cause quality deviations during the production of medicines and can influence their effectiveness. Therefore, an understanding of this phenomenon and its implications opens a wide field of possibilities to be explored in the pharmaceutical field, including the emergence of new paradigms and tools for the quality assurance of medicines. This paper presents an introduction to basic aspects of the polymorphism phenomenon and its implications for the production and control of medicines, with emphasis on drug polymorphs.

Contaminação das águas por resíduos de medicamentos: Ênfase ao cloridrato de fluoxetina

The objective of this paper was to review data on residues of medical products in aquatic environments and at wastewater treatment plants. Secondarily the paper presents a discussion about the need for a good management of drugs residues and effluents generated by this sector. Bringing the evidences of environmental possible damages reported by ecotoxicity data on the effects of fluoxetine to Vibrio fischeri and H. azteca, aquatic organisms daily exposed to environmental contaminants. From the results we observed that 0.3 mg.l-1 of fluoxetine hidrochloride induced lethality to H. azteca and 30 mg.l-1 reduced the luminescence of Vibrio fischeri. This assay evidenced higher toxicity when we used the generic product.

Perfilhamento do trigo em função da aplicação de regulador vegetal

Tillers survival and yield potential are genetically determined and strongly influenced by environmental conditions during the emission and establishment stage. This experiment was carried in order to study effects of application of growth regulator (Ax+GA+CK) on tiller survival and yield potential of wheat. The experiment was carried out from March to July 2010. A 2 × 2 factorial randomized block design with five replications was used. Two wheat cultivars (IAC 370 and IAC 375) and application or not of Ax+GA+CK at the beginning of tillering stage were evaluated. Tiller emission were evaluated at five ages (19, 26, 33, 40 e 47 days after emergence) and yield components were determined by each individual structure evaluation, comparing to the main stem. Growth regulator application improved the tiller survival when emitted in the first week after application. Tiller yield potential decreased in late emission periods of tillers in both cultivars tested, influenced by different traits of each cultivar. IAC 370 showed higher tiller emission, however, the number of viable tillers were higher for the IAC 375.

Análise das propagandas dos medicamentos isentos de prescrição veiculadas em revistas para prescritores na área médica

This article presents an analysis of the quality of advertisements for over-the-counter (OTC) drugs addressed to the medical profession, based on the new Anvisa resolution RDC 96 (17/12/2008). For this analysis, 16 volumes of the Brazilian Journal of Medicine (RBM) were collected, from August 2009 to December 2010. To investigate the quality of the adverts, we prepared a questionnaire divided into three parts. In total, 160 advertisements were found, of which 27 were related to drugs exempt from prescription, from 9 laboratories. It was observed that none of the advertisements complied fully with the new rules, as required by legislation (RDC 96/08), with violations ranging from identification of the advert to prohibitions of human figures and subjective messages. Therefore, it was concluded that there is a need to implement more effective monitoring, so as to improve the quality of the adverts, so they can be used as a reliable source of information and update by prescribers.

Intervenções educativas com usuários de medicamentos como estratégias terapêuticas

A review and analysis of the literature on educative interventions (EI) for medicine users was carried out. For this purpose, databases were searched by employing descriptors related to pharmaceutical care, education and health, covering the period from 1997 to early 2011. A set of 21 articles related to EI with medicine users were selected, 18 (85.7%) of which referred to studies on basic health care. The EI most commonly reported in the articles were: talks, group discussions and educative material. The positive outcomes reported were: improvement in quality of life (better acceptance of the disease), economic advantages (reduction in number of medical consultations) and clinical improvement (risk reduction, prevention of complications).

Alterações dos atributos químicos do solo e resposta da soja à cobertura vegetal e à calagem superficial na implantação do sistema de semeadura direta

Pós-graduação em Agronomia (Agricultura) - FCA