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In view of the growing concern with the safety of new drugs, and in view of the incorporation of RiskMAPs as a risk management strategy by the principal regulatory agencies, the objective of this study was to identify the drugs sold in Brazil that have RiskMAPs registered in the FDA, and the risk minimization actions put in place in Brazil by Anvisa and by the drug manufacturers.
Methods This is a descriptive, documentary, quantitative study, consisting of research on sites and databases of the drug regulatory agencies and questioning of pharmaceutical companies by correspondence sent to the web addresses of their customer service departments - CSDs.
The FDA site was accessed and in the section on drug safety the relationship between those with a RiskMAP approved up to the access date July 5, These drugs were researched for availability in the Brazilian pharmaceutical market.
To identify registry in Brazil, the drug database of the Brazilian National Health Supervision Agency Anvisa was consulted, and the following information collected: The date of first registry in Brazil; the manufacturer; and the name of the pharmaceutical specialty classified as the reference drug Consulta de medicamentos, To identify the reference drug, the specific list available on the Anvisa site in the drugs section was used as source of research The RiskMAPs of the drugs registered in the United States and in Brazil were analyzed to identify the measures employed and the key aspects involved in minimization of risk.
Existence in Brazil was verified by email sent to the customer CSD of the manufacturer that produces the reference drug in Brazil. In the pharmacovigilance section of the Anvisa website Research was also undertaken in the page of the Anvisa For organization of the data, an instrument of collection was prepared grounded on a literature review about strategies for minimization of risks. A database was developed in Epidata 3. The descriptive statistical analysis, made in SPSS As to the nature of the drug, 29 Among these, those with the greatest absolute frequently Table 1 were inhalable adrenal stimulants 7 , immunosuppressants 6 and drugs that reduce glycaemia, excluding insulins 4.
Table 1 Absolute frequency of drugs with RiskMAP and safety warnings on package leaflet and website, by regulatory agency. Table 1 shows that on the Anvisa site, information about the safety of use was available for only 15 drugs On the package leaflets of the Brazilian drugs, information with use safety warnings was found in 32 Risk minimization actions were directed to health professionals and patients. It was found that 35 of the 40 RiskMAPs had actions in which the target was health professionals, while for 23 the patient or drug user was the target.
There were cases of both being referred to in a single RiskMAP. Among the actions directed to health professionals, specific actions for doctors, nurses and pharmacists were identified.
Information on risks associated with use and in relation to possible adverse drug reactions was the most prevalent. After consultation of the drug manufacturers, it was found that the manufacturers stated that they were developing a RiskMAP in Brazil for only four drugs Table 1 , these being the same as those of the USA, and they referenced the site of the FDA, in the English language, as a mechanism for access to the RiskMAP.
Of the 36 We report that seven Among the drugs identified with registry in Brazil, 32 The mean time of registry with Anvisa was 5. Discussion Development of RiskMAPs by drug manufacturers established in Brazil is still at an incipient stage, since only four manufacturers say that they have them.
It is important to highlight that This underlines the need for improvement in the means of communication, with the creation of a space on the site of Anvisa, as is the case with the FDA, for publication of RiskMAPs. Another problem that is an obstacle to communication about the health risk of the drug is publication of the RiskMAP in a language other than Portuguese, since language is also an important instrument for understanding of information published.
To achieve the objectives of putting RiskMAPs in place the manufacturers should make them available and Anvisa should make access to them possible for health professionals. Considering that To optimize results in pharmacovigilance the contribution of health professionals and of the patients themselves — who are considered to be the priority targets of RiskMAPs — is essential.
The choice of the appropriate means of communication is essential to reach the target public and achieve the expected objectives In terms of communication, no strategy should be generic, since no strategy in particular can provide the same results when applied to different publics.
It is ideal for there to be more than one type of communication for each target group, and also repetition of messages to achieve a result in the long term This can be shown by looking at the frequency of the strategies for promotion of safe use of drugs in this study.
From the results, it is seen that there is more than one means of communication available for reaching the desired publics, and some can be used to notify health professionals and the patients simultaneously.
Supply of educational material is a predominant strategy in RiskMAPs, since providing it can minimize risks relatively easily, that is to say, it is simple to produce and implement as well as being able to cover various target publics In Brazil actions for communication of health risk of drugs is still at an incipient phase. On the package leaflet there is a larger number of warnings: for However, there are some limitations to communication of a warning through the package leaflet of a drug, making other means of communication necessary.
One drug that attracted attention in relation to the risk communication strategy was Thalidomide. Anvisa created a blog making a range of information about this drug available to the public Blog Talidomida, It is clear that Anvisa has carried out intensive work to guarantee safe use of this drug and to establish an appropriate communication with health professionals and patients, but it is essential that the manufacturer should also participate in these actions, since the blog does not explicitly refer to actions in relation to the manufacturer.
Some children were born after with birth defects compatible with the phenotype of embryopathy caused by thalidomide — showing that control of use and dispensation of the drug failed in the country Clinical use and control of the dispensing of thalidomide in Brasilia-Federal District, Brazil, from to Cien Saude Colet ; 18 11 Actions by Anvisa to amplify the publication of information about the safety of Thalidomide contribute to optimization of control of its use and dispensation.
New drugs need more active pharmacovigilance, especially the biological drugs, since limited information about the therapeutic action and adverse reactions of these products narrows their safety profile in comparison to those of a chemical nature.
Some of the aspects that determine the safety of drugs that contain biological agents are related to the complexity of the production processes and of purification, and to the high potential for formation of antibodies Evaluation of post-authorization safety studies in the first cohort of EU risk management plans at time of regulatory approval.
Drug Saf ; 32 12 The new technologies constitute a challenge for health surveillance because it is their competency to monitor the adverse effects and risks of the technological resources, products and services used by the health system Cien Saude Colet ; 19 7 The large number of pharmaceutical specialties in the Brazilian market; the problems relating to their safety and quality; and the registry of new biological drugs and nanotechnologies show the dimension of the challenge and the importance of the health regulatory action of Anvisa Cien Saude Colet ; 13 Supl.
The health professionals that work at these levels of care should know what the risks associated with these drugs are, with a view to minimizing them within the institutions, through systems of surveillance and risk management.
In the case of the present study, drugs that had secondary effects on the nervous system were not examined, but rather those that had some outcome in this system. There was also a significant association between use of medication for the musculoskeletal system and sex. The female sex and age were risk factors for primary osteoporosis.
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Treatment for primary osteoporosis or the consequences thereof pain resulting from fractures is related to the use of medication The presence of osteoporosis can have a direct influence on creating limitations in actions that require greater flexibility of the body, such as farm labor.
A study in Ethiopia, with rural workers, demonstrated that women worked an average of 26 hours per week in agriculture, i. In this sense, according to data from the national survey by household sample, only Among men, Women who work in farming do so with fewer technological resources and infrastructure than men and also have a longer workday, since they also do household chores 25 , which can lead to physical overload and pain in the musculoskeletal system.
This may be even more significant among elderly women who, due to the aging process, have decreased bone mass, loss of muscle strength, less ligament elasticity and wear and tear on the joints, reducing the ability of women to perform their normal duties, which could lead to the use of medication for the musculoskeletal system The use of medication to alleviate pain, such as muscle relaxants, is inappropriate for the elderly, due to their sedative effect There was no statistically significant association between age under or over 70 years old and medication use, number of medications used per day and type of medication used, which is consistent with the findings in the literature for elderly people residing in rural areas The workload required for farm tasks with the use of medication was associated with frustration demand.
Frustration is related to motivation, satisfaction, discouragement and irritation with farm work. Nevertheless, it is believed that work is beneficial for the health of elderly people, since studies show that work for elderly people in rural communities is a protective factor against a decline in basic and instrumental activities in daily life A study conducted in Brazil with farmers from two rural areas reported that repetitive work, followed by lifting heavy loads and incorrect posture, were among the main workloads identified by rural workers Although no association was found between physical, temporal, performance and effort demands and medication use, their association can result in physical overload, especially of the musculoskeletal system, and consequently lead to higher use of medication for this system.
The use of this medication among women in the present study was significant, even though the association with workload was not significant.
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There was also no association between mental demand thinking, choosing, calculating and deciding and use of medication in the study and, in the case of women, its use for the nervous system was significant, despite the fact that there was no significant association with workload. However, what is interesting is that, even without an association, mental overload exists.
This needs to be better clarified in terms of the factors associated with it, for this group in particular. This could be explored further in other studies, since mental demand, in other studies, was found to be conducive to mental disorders, such as anxiety and stress A limitation of the present study is that the data presented cannot be generalized due to the sample size.
In relation to the factors associated with medication use by elderly people residing in rural areas, the study only examined the relationship between use, type and number of medications for the variables of sex and age. Knowing the prevalence of medication use, associated factors and the relationship between workload and medication use could facilitate the development of activities, such as group follow-up in personal and family environments, in collaboration with basic health teams, through interdisciplinary initiatives.
Such initiatives can provide detailed assessments of medication use, effects, benefits and possible reductions or replacements by other options, characterized by a dynamic and continuous process. The findings of the study constitute a public health issue and, for this reason, should be discussed in the nursing field, in order to improve specific knowledge on the care of elderly people and rural workers - as in the case that medication use is associated with the female sex and frustration with work.
Therefore, it is proposed that further studies be conducted, through integrating intervention studies on the socioenvironmental health of workers and the health of elderly people.
The ones used by women the most were for the cardiovascular system, followed by those for the nervous and musculoskeletal systems. It should be considered that the rural workload of elderly people is associated with higher use of medication. Therefore, knowing which demands mental, physical, temporal, performance, effort or frustration contribute more to increased workload may enable the development of health interventions to reduce, when possible, medication use.
In the case of the present study, the physical demand had the highest mean among elderly people who use medication, and level of frustration with rural tasks was associated with greater use of medication.
From this perspective, strategies should be contemplated that seek to reduce the physical and mental load of rural work, through investments in public policies that make it possible for elderly people to reduce subsistence-based rural labor and, consequently, their workload.
Portaria n. Rio de Janeiro; [citado nov. Functional capacity to perform activities of daily living among older persons living in rural areas registered in the Family Health Strategy. Cien Saude Coletiva [Internet]. Grading of workload of male and female agricultural workers.
J Agric Technol. Low back pain in farmers: the association with agricultural work management, disability, and quality of life in Korean farmers. European Risk Observatory Report. Work-related musculoskeletal disorders in the EU: facts and figures [Internet].site Music Stream millions of songs. New drugs need more active pharmacovigilance, especially the biological drugs, since limited information about the therapeutic action and adverse reactions of these products narrows their safety profile in comparison to those of a chemical nature.
L Eixample. Frustration is related to motivation, satisfaction, discouragement and irritation with farm work. The RMP is an important strategy in public health for managing new risks, monitoring known risks and, especially, for promoting the safe use of medication.
Polypharmacy and polymorbidity in older adults in Brazil: a public health challenge.
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