Safety pharmacology - Essay Example

?Safety pharmacology Introduction Safety pharmacology is a scientific study concerned with the analysis and evaluation of undesirable effects of drugs during dosage. The development process of drugs incorporates the effective composition of evaluated chemicals thereby ensuring that they provide a solution to the disease by either killing the germ causing the discomfort thereby curing the disease or suppressing the effects of the external substance as is the cases with retroviral drugs thereby causing relief to the patients. However, certain drugs react differently with the bodies thereby causing more harm to the patients. The study of safety pharmacology therefore investigates such and seeks to develop safe drugs that do not inconvenience users by reacting adversely with their bodies. Safety pharmacology therefore relates closely with the study of toxicology in the drug development process, which refers to the evaluation of the safety of the drug composition before validating their safety in curing diseases. The practice of toxicology complies with several international drug safety organizations and international safety guidelines, which dictate that the toxicologists carry out extensive tests on the chemicals used in developing the drugs on animals among other specimens before introducing such substances on humans. Toxicologists therefore test the chemicals on similar animal parts and validating the safety of the chemicals on humans thereby minimizing the risks that such may present to humans who subsequently consume the drugs. Safety pharmacology is a fast growing discipline that seeks to predict the possible effects of a specific drug and possibly eliminating the negative effects thereby creating a safe environment for patients to use safe drugs. Most drugs react differently in people. this implies that different people have varying immunity level and antibody imbalance and therefore require both effective testing and prescription to ensure the consumption of appropriate drugs which safeguard the both the safety of the patient and the eradication of the discomfort. This seeks to eliminate the adverse drug reaction which experienced by certain people after consuming the different drugs. Adverse drug reaction abbreviated as ADR is a countenance of harm associated with the consumption of a drug at normal dosage and in an effective drug combination as directed by either a doctor or a physician. At normal dosage and with an effective diagnosis, a drug should counter the effects of the disease causing pathogens possibly eliminating it but not result in other secondary harmful effects. Such an occurrence therefore hints a harmful chemical composition of the drug thereby causing the secondary harm. ADRs are different from side effects, which are both positive and negative. ADRs are therefore purely negative and may include the worsening of the disease that the drug was to treat or introduce an entirely new medical condition to the patient. There are different degrees of drug reactions categorized as adverse drug reactions referred to as severity; such include the death of a patient, which is the highest risk that a drug should ever have. The human life is of integral value and drug developers operate with a key objective of sustaining it. Any human death resulting from the consumption of a drug meant to cure a disease is therefore the culmination of carelessness in the drug manufacture. Life threatening is yet another dangerous category. Such refer to a situation in which the patient risks dying by suffering acute reactions. However, in such cases, the patients stand a chance of survival if administered with immediate and effective medical attention. Disability is yet another adverse drug reaction referring to any form of permanent, persistent and significant disability in the normal functioning of the patient’s body. Certain drug chemicals result in functional anomalies in the bodies of their patients some of which are permanent since they involve amputation of body organs. Such are adverse and therefore categorized as either negative side effects or adverse drug reaction (Waladkhani, 2008). Safety pharmacology became a discipline associated with the study of drug toxicology and eradication of such substances thereby developing safer drugs for the treatment of diseases. The introduction of the discipline resulted from the use of a commonly used drug, which had varied negative side effects. Terfenadine used as a common antihistamine and thought effective in the treatment of the condition. Different companies in different regions marketed the drug under different names. The drug completely metabolized in the liver soon after leaving the digestive system thereby making unidentifiable in the plasma. Owing to this, it was therefore difficult to determine that the drug had a specific adverse reaction in nearly all the one hundred patients who used the drug in 1990. The drug had a systematic disruption on the electric rhythm of the heart especially among those who used it for long. The nature of the drug metabolism made it more difficult to determine the cause of the disruption a feature that resulted in the drug causing varying degrees of negative effects on its users who had no adequate information on its nature. The investigation of the drug exposed the discrepancy in the chemical composition possibly causing the shock to the heart lapses. The terfenadine composition caused the disruption a feature that resulted in the elimination of the drug from the respective markets across the United States of America and the United Kingdom. The drug caused varying degrees of the adverse reactions in patients ranging from life threatening to congenital anomaly thus validating the revision of its chemical composition and the subsequent ban on the drug and its constituents from the markets. The drug endangered the lives of millions of unsuspecting consumers thereby resulting in the development of safety pharmacology as a discipline in order to oversee the development of drugs and investigate the subsequent consumption of the drugs in the market for any possible adverse reactions from the patients. This was in the effort to create a safer drug environment for patients and to prevent any deaths or disabilities associated with the consumption of drugs. To oversee the drug manufacturing process, the ICH guidelines provide for an effective drug manufacturing process by stating the effective steps in the testing of the chemicals in the drug in order to ascertain their safety before introducing such to humans. The guidelines dictate an effective scientific systematic method to test the chemicals in the drug and the final testing to the completely developed drug to ensure their safety before recommending any for human consumption. Scientific testing incorporates experiments which offer the scientists a vivid evidence of the chemical reactions and their possible effects of the respective specimens. This way, the developers have scientific way of not only observing the antibody reactions with the introduction of the foreign substance but to also advice on the possible alternatives, which promise lesser or no negative side effects. Drug development is a scientific process guided by numerous procedures to achieve effectiveness of the drug. This further validates the need for a scientific testing of the very drugs to ensure and uphold drug safety among patients and medical practitioners. In the event of an acute drug reaction such as death or disability, a number of people take responsibility including the drug manufacturers for misleading the practitioners and the publics. This therefore implies that the concerned bodies must take responsibility and ascertain the safety of the drugs a feature that necessitated the formation of the ICH guidelines in the drug development process. One key requirement of the ICH guidelines is the repeat dose toxicity test which the guidelines advice is conducted on rodents for more than six months before ascertaining the safety of the drugs. Rodents such as mice and rats are mammals with a closer relation of humans and other primates on a number of features. They therefore form an effective specimen for the testing and evaluation of substances used by humans. Finalized under step four in 1998, the ICH guidelines granted drug developers to use rats as key specimens in the development of safer drugs of a particular category. This includes repeat test among different rodents which possess different traits. Such provide an effective platform to observe the diverse reactions of the different rodents thereby informing the incorporation of safety mechanisms, which includes changing the chemical composition of a dosage before testing it again in another similar rodent until they determine a safer drug for the specific DNA composition in the target consumer. Bibliography Waladkhani, A. R. (2008). Conducting clinical trials. A theoretical and practical guide. New York: Mc Graw Hill. Read More