The Security Evaluation Of A Medicine

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The security evaluation of a medicine

"Medicine is a science of uncertainty and an art of probability". (William Osler). In medicine health professionals know that the effectiveness of medications is based on a statistical study because each patient reacts differently to drugs. For this reason, the administration of a certain drug must be evaluated according to the patient’s needs, that is, it is based on personalized medicine. For this reason, it is important to evaluate the safety of a medication, through the safety margin, therapeutic index, adverse effects, interactions, adequate doses and the studies that have been carried out so that the drug. In the following paragraphs, information will be expanded on how to determine if a drug is safe for prescription. (Espinosa, 2015)

Chemicals, medication discovery and all advances in medicine have served to improve health problems in the population, however, according to records made by the UTE, people who have entered the emergency for poisoning have as a third cause the use of the useof medicines, being so that in 63% they have taken them intentionally, 35% accidentally, 0.1% for adverse reactions and 2% is due to other causes. These data are alarming because a large percentage of the population does not know how the safety of a drug should be evaluated and this is because doctors do not inform patients that medicines even free sale can cause damage to the health of the health of theindividual if you do not know the pharmacological profile of the same. (Meneses, 2014)

The safety of medication is important to improve the health and quality of life of the sore, so it is substantial to publicize the patient the dose, schedule, adverse effects, etc. of the drug that will be used in the treatment of a certain disease. However, the doctor must also know and be able to assess whether the medication that is recipe is safe for the patient. Therefore, there are established parameters to evaluate the security of the medication such as security margin. (Rubio, 2015)

The safety margin refers to the dose in which a medication will perform a desired or unwanted effect, this depends if the person is sensitive, resistant or is among the normal population of the individual response variability curve to a drug. In addition, the security margin is determined by the therapeutic index, which is that which compares the concentration of the drug that in blood circulation causes toxic effects to the organism, because of this, it is important to know if the therapeutic index is reduced, this indicates thatAt minimum concentrations it can be harmful to health, however, if the index is wide, the medicine is safer. (Catalá, 2018)

It is also essential to know the development phases of an old or new medication to know if the drug is safe for individuals, these phases are the preclinical that investigates the physicochemical composition, the pharmaceutical form and the toxicological evaluation of the drug, this is done inTwo different species of animals and once it has been approved by the Food and Drug Administration (FDA) will take place to study in humans, this phase is called clinical trials. (Bosch, 2018)

Clinical studies are based on an experimental double -blind evaluation that sample size is 50 to 500 voluntary individuals to avoid errors in the result. The essay consists of administering in voluntary individuals who do not have pathological processes in order to know the pharmacokinetics with which it is intended to analyze the adsorption, release, metabolism and excretion of the drug, also allows to know the pharmacodynamics that is to know how the drug acts inThe body, another objective of the trial is to determine the therapeutic effectiveness in order to know the useful doses, tolerability and adverse effects, in this way the security of the medication is established. (Campillo, 2018)

The last phase is called a controlled clinical trial that aims. Once the pharmaceutical company has approved all the experimental phases ethically, the FDA performs an analysis of the process for the approval or rejection of the marketing of the medication. (Campillo, 2018)

In spite, that the new drug approves all experimental phases does not guarantee that the risk and benefit relationship is established, but has complied with the necessary parameters in the short term to be stable with respect to its pharmacological profile, however, efficacyAnd the adverse effects of medication will be known after 7 years that are in the market, because the only way to know the true functioning of the medication is through repetitive exposure, for this reason pharmacovigilance performs phase four with the purpose with the purposeto supervise the security of the use of medication in special populations such as children, elders and pregnant women. (Villegas, 2018)

The patient also has the obligation to know and know all the necessary information regarding the drug that has been prescribed, so like the health professional, the interactions presented by the medicine with food, other drugs, drinks orA supplement because it can reduce effectiveness and cause even poisoning in the body, it is also importantSpecial populations. (Rubio, 2015)

In conclusion, it is important that the safety of a medicine is responsibility both that of pharmaceutical companies, health professionals and patients because negative consequences in the health of human beings must be avoided. In my opinion, good security is achieved through communication and a good medical-patient relationship, because an adequate medical history, a correct diagnosis and therefore the correct prescription of the medication and a good adherence to the same. Likewise, it allows the patient to be educated about the therapeutic dose of the medication, the duration of the effect, the interactions and the possible side effects that may arise during treatment. In addition, companies have the responsibility to perform low -dose drugcome to consumers are safe. (Rubio, 2015)


  1. Catalá-López, f., & Ridao, M. (2018). Rapid evaluations of the efficacy and safety of new medications. Sanitary Gazette, 32, 106-107.
  2. Bosch, f., Scales, c., Forteza, a., Servés, e., & Casino, G. (2018). Checklist to improve drug information in the press: the importance of informing about the phases and uncertainty of research = A Checklist for Improving Drug Information in the General Press: The Importance of Reporting on The Phasses and Uncertaintity of Research. Spanish Journal of Health Communication, 9 (2), 203-214.
  3. Campillo, n. AND., & Alonso, M. D. C. F. (2018). How a medicine is manufactured. THE BOOKS OF THE CATARACT.
  4. Villegas, f., Figueroa-Montero, d., Barber-Becerra, v., Juarez-Hernández, e., Uribe, m., Chávez-Tapia, n., & González-Chon, or. (2018). The importance of in -hospital pharmacovigilance in the timely detection of medication errors. Medical Gazette of Mexico, 154 (2), 172-179.
  5. Rubio, j. S., García-Delgado, p., Iglésias-Ferreira, p., Mateus-Santos, h., & Martínez-Martínez, F. (2015). Measurement of the patient’s knowledge about his medicine in community pharmacy in Portugal. Ciência & Saúde Coletiva, 20 (1), 219-228.
  6. Espinosa Brito, to. (2015). People -centered medicine and personalized medicine. Medisur, 13 (6), 920-924.
  7. Meneses, c. (2014). Poisoning in Ecuador. UTE MAGAZINE, 1-11.

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