Human health is considered to be one of the most valuable things for the government and this is why the enormous sums of money are appropriated for research programs aimed at developing new drugs that would be cheaper, safer to use, and more effective. Drug development is a complicated process that involves proving that the drug is safe for human consumption, its effectiveness is much more significant than its side-effects and its present form is the best for delivering its active materials to the organ that needs treatment. The effectiveness of medicinal drugs is one of the key factors that define the result of the treatment.
Nonsteroidal anti-inflammatory drugs or NSAIDs belong to the group of drugs that have pain alleviating and anti febrile effect. If they are taken in comparatively high doses, they can also provide an anti-inflammatory effect. NSAIDs are regarded as one of the most efficient types of drugs and in many countries, people are not allowed to buy them if they do not have a doctors prescription. Anyway, there are certain nonprescription NSAIDs such as ibuprofen and aspirin.
Being so effective, they also possess a range of possible side-effects, and using them without specialized medical consultation may sometimes lead to additional health issues. The group of NSAIDs comprises different medicinal drugs that oppress the activity of the cyclooxygenase. The latter is a ferment taking part in the synthesis of inflammatory markers that are substances causing the sharp rise of body temperature and the presence of pain syndrome.
There are three types of cyclooxygenase that possess various properties and in order to block the activity of each type, scientists developed three types of NSAIDs. All of them are to be used under close medical supervision because there can be individual side-effects as renal insufficiency or drug-induced hepatitis. Nevertheless, NSAIDs can be used during the treatment of many health issues as they have various positive effects. They are recommended to be used in the treatment of rheumatic and musculoskeletal diseases, post-surgical pain syndrome, headache, renal colic, fever, and even dysmenorrhea.
Nonsteroidal anti-inflammatory drugs should be distinguished from steroids. These groups have many things in common as they both have strong anti-inflammatory and fever-reducing action. They are called nonsteroidal because there is a need to draw a line between NSAIDs and glucocorticoids that also prevent inflammation but have a lot of common properties with steroids. Some of these properties are really dangerous for our bodies.
As for NSAIDs, they definitely do less harm to our health and this is why they remain more preferable during the treatment than steroids. Even if we take into consideration the variety of possible side-effects caused by medical malpractice with the use of NSAIDs, it would not affect its numerous health benefits. The use of NSAIDs is one of the best ways to struggle inflammation on a certain part of the body and the pain syndrome that may manifest itself in the pain of different types such as acute, poignant, and chronic. The ability to alleviate even excruciating pain is believed to be one of the most important properties of this type of medical drugs. NSAIDs consist of the active component that is responsible for pain-alleviating and fever-reducing effects, and there are also additional components that enhance its effect and make the drug act faster.
Nonsteroidal anti-inflammatory drugs are able to offer significant relief from pain and this is why they remain one of the most used groups of drugs. What is more, they also have a certain anti-cancer effect that allows them to use them to alleviate cancer pain (Valle at al., 2012, p. 4673). The additional benefit is that they are allowed to be used not only by adult people; the treatment with the use of NSAIDs is also possible for children.
In case if they are ingested these drugs in an appropriate dose for their age and weight, there will not be any problems. Another significant advantage of NSAIDs is that they are able to provide a strong anti-inflammatory effect. It generally refers to NSAIDs that contain ibuprofen. As for the latter, it is also possible to be used by both adult people and children but the right dose should be measured out thoroughly. NSAIDs are good for inflammation management as they are able to prevent inflammation in any part of the body including joints and it makes them useful for the individuals suffering from arthritis (Lee, 2013, p.1).
What is more, they are easily accessible from the chemists shops and one can always buy NSAIDs that are sold without a prescription to alleviate the pain and prevent the inflammatory process. More than that, they tend to be comparatively cheap and their price combined with their effectiveness make NSAIDs to be perfect medical drugs for urgent treatment.
Conclusion
To conclude, NSAIDs are able to produce various positive effects on human health; they prevent and reduce inflammation in any part of the body. They are able to bring significant pain alleviation even to people ill with cancer and they can be used by people of all ages on condition that the dosage is right.
References
Lee, Y. C. (2013). Effect and treatment of chronic pain in inflammatory arthritis. Current rheumatology reports, 15(1), 1-8.
Valle, B. L., DSouza, T., Becker, K. G., Wood, W. H., Wersto, R. P., & Morin, P. J. (2012). The anti-proliferative effects of non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac and indomethacin in ovarian cancer cells. Cancer Research, 72(8), 4673-4673.
Americas War on Drugs has been going on for decades, yet the victories seem to be mostly against the countrys own population. While drug accessibility did not become any lower since the 1960s and the 1970s, the rates and terms of incarceration for drug-related offenses skyrocketed during the same time period. A 2012 documentary, The House I Live In, goes as far as comparing this mass incarceration to the Holocaust and not without grounds. Just as the final solution of the Jewish question, incarceration fuelled by the War on Drugs is massive in scale, serves to provide the economy with cheap labor, and disproportionally targets a single minority.
Main body
One reason why a documentary about enforcing drug-related legislation begins with the images of the Holocaust is that the War on Drugs is also an example of incarceration on a truly massive scale. Although there may be no definite agreement on the numbers, it is common knowledge that Nazi Germany confined dozens of millions of people to its prisons and concentration camps during the 12 years of its existence. The War on Drugs has a score to match according to the film, 45 million people have been imprisoned for drug-related offenses since its beginning. Despite having only 5 percent of the worlds population, the USA accounts for roughly a quarter of its inmates, a considerable proportion of whom are casualties of the War on Drugs.
Apart from the mere scale, there is another similarity between the Holocaust and the mass incarceration due to the war or drugs its essentiality for the economy. The unpaid labor of inmates in the concentration camps fuelled Hitlers military machine and Germanys economy. In a similar vein, the prison-industrial complex enjoys the benefit of the convicts cheap labor to make itself more competitive. Moreover, the prisons and jails themselves provide employment for staff. At one point, the film notes that, if not for the Joseph Harp Correctional Center, the residents of the nearby town of Lexington, Oklahoma, would have little job opportunity.
Yet the way in which the comparison between the Holocaust and the War on Drugs makes the most sense is the fact that mass incarceration for drug-related offenses disproportionally targets one group of population. Much like Jews in Nazi Germany, African Americans have been consistently associated with societal problems, namely, the drug trade and abuse. It began in the 1950s when cocaine was stereotyped as a jazzmans drug and was further reinforced in the 1980s when crack cocaine became largely associated with poor black neighborhoods. The film calls this association the identification, when a group of people is labeled as the cause of societal issues. It also suggests that the phases of ostracism and outright confiscation of both rights and property are likely to follow. There is evidence of this in the case of black Americans being disproportionally arrested and sentenced for drug-related offenses. Thus, the documentary concludes its comparison between the Nazi Holocaust and the War on Drugs by showing how they lead to a gradual dehumanization of a given group in public discourse.
Summary
To summarize, The House I Live In highlights the unsavory parallels between the Holocaust and the mass incarceration fuelled by Americas War on Drugs. Much like the policies of Nazi Germany, incarceration for drug-related offenses hits dozens of millions and serves an economic purpose by supplying free or near-free labor. Yet the greatest similarity is the association of the drug problem with the black population that leads to their gradual dehumanization as a demographic with potentially dreadful consequences.
Acetaminophen is used in pain-relieving as an analgesic or fever alleviation as an antipyretic drug. The drug is available on its own as over the counter (OTC) drug, or as a combination with other OTC or prescription drugs. According to the Food and Drugs Authority (FDA), the intake of a large amount of acetaminophen causes liver damage (Yan par. 4). The authority also reports of rare but severe cases in which the drug has caused damages on the skin. Consequently, FDA ordered pharmaceutical firms to limit the amount of acetaminophen to levels below 325 mg in the formulation of combined drugs. This order is effective from January 2014 (Yan par. 7).
Yan writes the article on 16th of January 2014, two days after the FDA press release, to remind the American population that the 2011 FDA order to drug manufacturing companies has come to effect (FDA par. 1). This article reminds the consumers and medical practitioners of the existence of products containing acetaminophen above the regulated limits. These may be drugs manufactured before January 2014, or may be drugs formulated by pharmaceutical firms, which have not yet observed the 2011 FDA order. The writer of the article as well informs the consumers of the fatal liver damage caused by acetaminophen overdose. He informs the consumers to be vigilant with doctors prescriptions. According to Yan, consumers need to look for the word acetaminophen or APAP in the prescription leaflets (Yan par. 13).
According to this article, most of the patients are ignorant on the content of acetaminophen contained in the drug product they take. Therefore, a large number of these consumers unknowingly take more than the required amount of acetaminophen. For this reason, the Food and Drugs Authority on 14th of January 2014 ordered all health stakeholders to ensure that products containing more than 325 mg of acetaminophen are never prescribed (Yan par. 8). Consumers are unaware that many drug products contain acetaminophen, hence consume at the same time a variety of these drugs, which consequently risk their lives. Acetaminophen is often formulated as combination drugs with pain medications like hydrocodone (as in Vicodon), codeine (as in Extra Strength Tylenol) and oxycodone (as in Percocet). Some of these drugs still contain content of acetaminophen above the regulated amount (Yan par. 3).
The objective of the Food and Drugs Authority regulation on products containing acetaminophen is to reduce the number of liver poisoning or deaths caused by acetaminophen overdoses. The required dose of acetaminophen per day is 4 grams, a quantity that can be reached by taking 8 tablets of Extra Strength Tylenol. The Authority also advises consumers not to take at the same time different products containing acetaminophen. This requirement will limit the unintended overdose (Yan par. 10).
This is an interesting article in the fight of drug overdose. The writer of the article, Mr. Holly Yan, is a CNN journalist who has taken the role of informing the public on the dangers of overdosing acetaminophen. It is worrying that FDA does not ensure that its regulation is implemented as required. The Authority could have made a thorough campaign against using drugs with acetaminophen above the specification before the effective date of the regulation (FDA par. 3). Holly Yan realizes that the new FDA press release may have not reached a significant number of the audience thus; he informs the audience who did not have this information.
This summary appreciates the extraordinary work made by journalist like Yan who impart the public with healthcare information. The objective of this choice is to enlist private citizens who ensure that drug consumers are well informed.
Works Cited
FDA. Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement Recommendation to Discontinue Prescribing and Dispensing. 2014. Web.
Worldwide, Americans enjoy a higher sophistication and choice when it comes to drugs and medical devices. New drugs and medical devices are constantly being discovered and developed. Thus, it has become important for the federal government to certify which drugs and medical devices are safe for use. Both medical devices and new drugs undergo various approval processes before they are released into the general population. Such activities are carried out by the Food and Drug Administration (FDA) (Sweet, Schwemm, & Parsons, 2011). Even though this agency plays a major role in approving the use of the various drugs and medical devices locally, it is also a significant player in determining their exportation.
Thus, a drug that has not been approved by the FDA will not be easily accepted in international markets. The FDA also acts as a reference point for foreign governments in determining whether they will approve specific drugs and medical devices from the U.S. In any given year, the FDA removes approximately 1-2 new drugs and 6-8 medical devices from the market because of safety concerns (Whitmore, 2012).
Operations
The Centre of Drug Evaluation and Research (CDER) is the body that the FDA uses as the regulatory body to oversee the safety of drugs and medical devices. The CDERs main task is to evaluate new drugs before they are released into the market. Thus, it prevents quackery and provides information to both doctors and patients on how they can use drugs (Sweet, Schwemm, & Parsons, 2011). Both drugs and new devices are considered by the FDA. This includes analysis of such drugs and medical devices to ensure that their benefits are way more than the health risks arising from their use.
Similarities
Drug companies are mandated to conduct tests on a new drug before they can sell the drug. The test results are then sent to CDER to show that the said drug is effective and safe with regard to its intended use. CDER has various professionals who analyze the drug further. The data from the company is analyzed by these individuals, including a proposal for labeling and drug use. This is similar to new medical devices. Generally, the manufacturing company tests the devices and forwards the results to the FDA. These results are then analyzed to ensure that they are true, the devices are safe, and they will work as expected (Garber et al., 2000).
For both medical devices and new drugs, the approval process involves less research with regard to the safety, quality, and effectiveness. The company selling the new devices and drugs is expected to conduct detailed research. The FDA is only involved in analysis of the research data provided by the company and only carries out limited research on its own. The data collected is determined by the various steps a manufacturer takes during the development of a new drug or device. Conducting lab tests on the new drug or device is usually the initial step in the approval process. This is done to determine what exactly the drug intends to do (Whitmore, 2012). Thus, the researchers become aware that the drug has various medical implications.
In comparison, new medical devices are categorized into various classes depending on the risks that arise from the specific device. They are categorized into three classes. The first class deals with general controls. This means that devices under this category have passed the general safety requirements required by the FDA. The second class is dependent on how the device is used. Thus, such a device is ranked depending on what special controls are required, besides the general controls. This can involve having labels on the device, testing, and performance standard requirements. Devices that are ranked as class three usually have medical implications on the user. These are devices used in the support or sustenance of life, implants, and can cause injury. Thus, both new drugs and medical devices undergo this stage, but they are usually just a concept. In other words, they have not undergone any production, but they are only an idea that the FDA is informed about (Garber et al., 2000).
Both new drugs and medical devices are patented during the initial phases of their development. Thus, the agency considers the intellectual ownership during the approval process. In case of new drugs, other companies can apply to produce generic drugs later through the FDA. For most of them, they will not undergo a stringent approval process if they follow all the requirements of the original drug manufacturer. In the case of new medical devices, manufacturers rarely let other companies produce their devices. This is usually related to the economic costs of a machine, thus a company would want to retain its profits if there is a small demand for the new medical device (Garber et al., 2000).
The FDA has a shorter approval process for a new medical device that has proven to work just as good and safe like an already marketed medical device of similar functionality. This is known as the 500(k) process (Sweet, Schwemm, & Parsons, 2011). The general and special controls should be met before a device is allowed into the market. The device is approved when it is considered to have followed all requirements. This is the same case with generic formulations of drugs. Thus, the only data required is information that approves the drugs bioequivalence to the original drug. Moreover, clinical trials are not conducted because it takes a shorter time to be approved. The manufacturer submits an Abbreviated NDA (ANDA), which leads to the shortened time. This abbreviated process has its beginnings on the Hatch-Waxman Act passed in 1984 to reduce the approval process for generic drugs (Whitmore, 2012).
The approval process also involves clinical trials. Medical devices go through a short clinical trial period in comparison to new drugs. Moreover, the FDA is involved in the approval of the clinical trials. Thus, it can stop or cancel the clinical trials if problems are encountered during the process. Even though the trials conducted before a new drug or device is marketed can provide conclusive information on its effects on the larger population, the results may not be accurate. Thus, the FDA continues to monitor both drugs and new medical devices after release into the market.
Differences
The main differences often arise when it comes to the quality assurance methods used by the FDA. The methods applied for the new drug involve a higher percentage of human subjects during clinical trials in comparison to new devices. The FDA will grant temporary approval allowing only the manufacturer to conduct post marketing studies after a new drug has passed testing through CDER. This is done to determine the drugs effect on a smaller market before more people can access the drug. Thus, the safety concerns and cost/benefit issues are considered during this time. The drugs efficacy is also assessed. In comparison, new medical devices are not allowed into the market, until the FDA is assured of their safety for use by humans (Sweet, Schwemm, & Parsons, 2011).
The approval process for new devices involves comparing them to devices that existed in the market before 1976. The devices made prior to 1976 were known as predicate devices, thus they act as a reference point when reviewing application for new devices. In comparison, new drugs do not undergo a comparison with drugs that are already made. Thus, drugs are considered as unique and the effects of each drug are based on trials conducted on the drug and not past experience.
It is the responsibility of the Food and Drug Administration to conduct quality control tests that certify drugs as suitable for treating people. A drug can easily cause death in comparison to a device. This increases the risks involved because a drug is intended to help a sick individual regain their normal condition. Drugs also have higher risks in relation to allergic reactions resulting from the use of such drugs. In some cases, the allergic reactions may be severe enough to lead to death. Thus, new drugs undergo a longer approval process in comparison to new machines. The approval process of new devices varies depending on the use of the device. Some devices may be very expensive and important. Thus, new medical devices go through a shorter approval process in comparison to a new drug (Whitmore, 2012).
The manufacturer of a new drug is supposed to submit their application for their Investigational New Drug (IND) during the approval process. This document shows the results of tests conducted on animals. The FDA can then approve whether the manufacturer can carry out further tests on human subjects. Despite this, several studies are still carried out on humans before the drug is approved. There is a major difference when it comes to new devices where tests on humans are not carried out before approval. Many medical devices, especially those categorized as class three, have to await the FDA approval before human trials can be conducted.
The FDA conducts random or planned inspections of manufacturing facilities to ensure that they meet the requirements that had been agreed upon. Moreover, a database has been established by the FDA to act as a reporting site for problems that may arise from the use of new drugs or medical devices. Thus, the FDA remains aware of the effects of the new drugs even after they are released into the market. This is different in the case of machines whereby few devices undergo randomized controlled trials (RCTs). Moreover, there are more device applications going through the FDA in comparison to new drug applications. This makes it harder for the FDA to conduct trials on all devices. Thus, inspection is prioritized depending on a devices safety and not efficacy (Benzon et al., 2013).
Conclusion
The procedure of approving a medical device is almost the same as that of approving a new drug. However, there are phases that differ between the two procedures. The approval process is usually guided by the safety and use of the new drug or device. In the U.S., the approval process is conducted by the FDA to ensure that the products released into the market have met various safety standards and are effective in usage. The approval process for a new drug is more stringent and takes more time compared to the process of approving a new medical device. Safety and efficacy assessments are conducted even after the new drug or device has been released into the market.
References
Benzon, H., Rathmell, J. P., Wu, C. L., Turk, D. C., Argoff, C. E., & Hurley, R. W. (2013). Practical management of pain (5th ed.). Philadelphia, PA: Elsevier/Saunders. Web.
Garber, S., Ridgley, M. S., Taylor, R. S., & Meili, R. (2000). Managed care and the evaluation and adoption of emerging medical technologies. Santa Monica, CA: RAND. Web.
Sweet, B. V., Schwemm, A. K., & Parsons, D. M. (2011). Review of the processes for FDA oversight of drugs. Journal of Managed Care Pharmacy, 17(1), 40-50. Web.
Whitmore, E. (2012). Development of FDA-regulated medical products: a translational approach (2nd ed.). Milwaukee, WI: ASQ Quality Press. Web.
A recombinant drug (a biologic) is produced through the application of biological processes involving DNA technologies. Biologic drugs are intended to be used to treat and manage diseases and health conditions in patients. Clinical trials would be used to obtain answers about the pharmacological product (Chow & Liu, 2013).
However, they are carried out after approvals from relevant bodies in different countries. A clinical trial involves four stages, which must all be passed to prove that a biologic drug is safe to use and produces good biological effects (Chow & Liu, 2013). The clinical phases and considerations in each phase are summarized as follows:
Phases
Considerations
Phase I
Safety
Pharmacodynamics
Pharmacokinetics
Tolerability
Phase II
Efficacy
Toxicity
Dosing requirements
Patients and healthy individuals
Phase III
Size
Duration
Expenses
Approval
Consumer response
Phase IV
Pharmacovigilance
Technical support
Drug interactions
Aggressive marketing
Figure 1. A table with a summary of the 4 phases of clinical trials.
Phase I
Phase I considerations for a biologic drug would include the following:
Safety
Pharmacodynamics
Pharmacokinetics
Tolerability
Safety
Drug safety is an important aspect that is assessed in clinical trials. The goal of assessing the safety of a drug is to ensure that it does not cause more adverse reactions than expected therapeutic benefits in the human body. The safety of the chosen recombinant drug would be determined in cases of pregnancy and overdose, among others (Chow & Liu, 2013).
It will be important to determine the level of drug benefits in the scenarios because they may lead to adverse drug reactions. Although much information regarding the safety of the drug would be obtained from human subjects participating in the clinical trials, some information would be accessed from medical literature and pharmacovigilance agreements (PVAs).
The safety consideration would encompass some aspects that would greatly determine the overall assessment in terms of safety. Adverse drug reactions are undesirable side effects that are caused by a drug. The drug benefit is defined as a therapeutic good that is associated with a drug.
Efficacy is the level to which a pharmacological product produces good efficacy. Harm is the extent to which a drug causes tissue damage. Effectiveness of a drug is the extent to which a drug is metabolized. Drug metabolism determines how a drug produces good efficacy levels in the human body (Chow & Liu, 2013).
The safety assessment in human subjects will mainly focus on comparing the benefits and limitations of the drug. It has been shown that drugs that produce many benefits in patients have low levels of harm. Such drugs are adopted in the healthcare industry because they have more benefits than adverse drug effects.
Pharmacodynamics
The pharmacodynamics consideration would involve studying the physiological effects that the drug would have on human subjects (Chow & Liu, 2013). In other words, the consideration will focus on deciphering the changes that the recombinant drug will introduce to body tissues. To determine the effects of the drug on the body tissues, it would be essential to understand how the drug would act. It might act on the body through two processes (Chow & Liu, 2013).
First, it might inhibit standard physiological or pathological events in the body. Second, it might produce efficacy by hindering important processes of parasites and other disease-causing organisms. Although the above are the two processes of drug activity, the following seven (7) actions have been demonstrated to be initiated by several classes of drugs:
Receptor agonism
Depressing action
Silent antagonism
Stabilizing action
Exchanging and replacing actions
Destruction of cells
Direct beneficial actions
The selected recombinant drug might produce a desirable biological activity by targeting the following components:
Cell membrane
Important chemical reactions in human cells
Transport proteins
Ion channels
Enzymes
Structural proteins
Receptors and ligands
A deep understanding of the components to be targeted by the drug under investigation would be essential in anticipating the effects of the drug on the study subjects.
It would be important to assess the type and level of undesirable effects of the drug in the human body. The following undesirable effects would be studied:
Carcinogenic activities
Harmful drug interactions
Abnormal chronic conditions
A series of deleterious actions
An understanding of the above effects would be essential in redesigning the drug if it would be found to have more harm than benefits.
The pharmacodynamics consideration would also focus on the therapeutic window of the biologic drug. The therapeutic window refers to the average amount of a drug that produces the best efficacy (Chow & Liu, 2013). In other words, it is an effective dose of a drug. The amount of drug falls between an effective dose and the dose that produces adverse effects.
Drugs with small therapeutic windows are given to patients with a lot of care and control. The blood of patients needs to be assessed routinely to determine the amount of the drug circulating in the body because it has very high chances of losing effects or producing adverse effects.
Lastly, the pharmacodynamics consideration would involve the assessment of the duration of action of the drug (Chow & Liu, 2013). Duration is the period during which a drug produces therapeutic changes in the body. Determining the duration of time of the recombinant drug would be important in scheduling the times of the day when patients should take the drug. Ideally, patients would be advised to take the drug when its plasma concentrations would have dropped considerably.
Tolerability
Tolerability or drug tolerance is an important clinical trial phase I consideration. Drug tolerance refers to a state when a bodys reaction to a certain amount that causes desirable effects reduces significantly. For the drug to achieve its therapeutic effects, its dose must be increased (Chow & Liu, 2013). It would be important to determine the tolerability levels of the biologic drug so that to determine the rate at which human beings would develop resistance against the drug. It is characterized by the following:
Reversibility
Drug specificity
Dosage
Frequency of drug usage
If it would be established that the drug would have tachyphylaxis, then further studies would be conducted to determine the causes of the sudden cause of drug tolerance. In such a case, it has been demonstrated; the dose is not the culprit. Two mechanisms of drug tolerance exist. First, pharmacological tolerance could be experienced in patients when a decreased amount of drug arrives at the target within the body.
This could be caused by induction activities of various enzymes involved in drug metabolism, for example, CYP450 enzymes (Chow & Liu, 2013). Second, pharmacodynamic tolerance would occur when there is a downregulation of the number of receptors involved in pharmacodynamics or increased number of receptor antagonists.
The two events would have a basis on the genes contained in the DNA. Expression of the genes leads to an increase in the number of receptor agonists or antagonists. It will be important to assess the causes of tolerance with regard to the selected recombinant drug during phase I of the clinical trials.
Pharmacokinetics
Pharmacokinetics refers to a collection of processes that determine the destination and the form of a drug in the human body. In other words, pharmacokinetics helps to understand the impact of body reactions on administered drugs. The study of the biologic drugs pharmacokinetics would help to determine the bioavailability. Bioavailability is the ratio of drug that reaches its target of the action. Drugs that have high values of bioavailability are characterized by excellent efficacy levels.
The bioavailability of the drug under investigation would be determined by several factors. First, the chemical form of the drug would impact the rate at which a pharmacological product would be metabolized and transported to sites of action. Second, drug metabolism will determine the amount of drug that would interact with the sites of actions. If drug metabolism would break down most of the drugs chemical components, then only a small proportion of the drug would reach biological targets.
Third, the stability of the drug would influence the amount that would produce biological effects at the sites of action. If the drug would be quite stable, then a considerable proportion would interact with receptors at the sites of action. Fourth, the pharmaceutical form of the drug would contribute to the drug proportion reaching its target.
Five components are used to define processes that characterize the pharmacokinetics (Chow & Liu, 2013). First, drug liberation is used to imply the collection of events that help a drug to be released into the body. Second, absorption is used to describe the process of a drug gaining access into the circulatory system. This is essential because drugs are transported to their sites of action by the blood. If the drug under investigation would be highly soluble in blood, then it would be easily transported to the sites of action.
Third, drug distribution is the process of taking the drug to body organs through the circulatory system. Excellent drug distribution mechanisms would result in good efficacy levels of the drug (ONeil, 2013).
Fourth, drug metabolism is the transformation of a drug by chemical components of the body. The process might result in biotransformation or inactivation of the recombinant drug under study. Fifth, drug excretion refers to the process of eliminating the drug from the body. This phase will determine whether the drug would accumulate in body tissues, or it would be removed from the body.
Healthy volunteers will be used in this phase of clinical trials, and they will be monitored at the first time of drug administration until many half-lives would have passed (De Angelis et al., 2005). At the end of this phase, the dose of the drug under investigation would be determined.
Phase II
Phase II trials will aim to assess whether the drug will have biological activities. They will be conducted on larger groups of subjects than those used in the phase I trials. Both healthy individuals and patients will be included in the trials. Phase II considerations for a biologic drug would include the following:
Efficacy
Toxicity
Dosing requirements
Patients and healthy individuals
Efficacy
The trials would adopt the approach of case series to assess the extent to which the recombinant drug produces desirable physiological effects that lead to improved health conditions of the study subjects. For example, the research team might hypothesize that the drug would have desirable biological effects in about 30% of the study participants.
If the researchers would find out that the biological effect is exhibited in less than 30% of the subjects, then they would conduct further studies on the drug that minimally tolerated drug doses. If they would obtain improved efficacy rates with the revised doses, then they would incorporate more subjects to calculate the estimate of the rates of response.
The drug would pass the phase II trials if it showed significant efficacy rates. Drugs with good efficacy rates are used in patients because of their good tested rates of biological activities (Chow & Liu, 2013).
Toxicity
If the drug will be confirmed to have significant efficacy rates, then researchers would observe and document the toxicity levels of the drug. It might be found that the drug would have higher toxicity levels at high doses than at lower doses (ONeil, 2013). The study team would aim to correlate doses with efficacy levels. They would have to reduce doses too low levels that would not produce any toxic effects. However, lower doses should still be able to elicit desirable therapeutic activities (Chow & Liu, 2013).
Dosing requirements
Dosing requirements are important in the second phase of clinical trials. The levels of doses that would produce the best pharmacological effects would be determined by finding an estimate of the average doses that would be observed in the subjects. Also, dosing ranges and intervals would be established.
The ranges would be used to establish the best doses for adults and children. Dosing intervals would be based on the values of the half-life of the drug. It the drugs half-life would be found to be short, then dosing intervals would be made short (Chow & Liu, 2013).
Patients and healthy individuals
The phase II trials will involve the use of the drug and placebos in both healthy individuals and patients. The drug activities will be assessed on the two groups of subjects. If there will be no difference in biological effects produced by the drug and placebos, then it will be established that the recombinant drug would have no significant efficacy rates. However, differences in physiological states of subjects given the drug and those given placebos would indicate that the pharmacological product would have significant efficacy levels.
In conclusion, phase II trials would be divided into phase IIA division that would determine dosing requirements, and phase IIB division that would involve the determination of the drugs efficacy (Chow & Liu, 2013).
Phase III
This phase will aim to determine the effectiveness of the new drug as a new intervention. It will also aim to assess the value of the drug in clinical practice. In this phase, the efficacy of the drug will be compared to that of the gold standard. It is an expensive phase that would involve randomized controlled trials on hundreds and thousands of patients. Phase III considerations for a biologic drug would include the following:
Size
Duration
Expenses
Approval
Consumer response
Size
Phase III trials are large, and they may involve about 300 to 3,000 study subjects. The number of subjects is based on the complexity of the targeted disease and health condition. The phase III of the drug trials would adopt a significant number of subjects. The sample size to be used would be calculated using a statistical tool. Sample size with a statistical power would be selected (Wang et al., 2007).
Duration
It would be important to conduct phase III trials for some time long enough to understand all issues that would not have been detected and solved in phase I and phase II trials. The randomized controlled multicenter trials would allow sufficient time for patient follow-ups to assess the efficacy of the new drug intervention in comparison with the gold standard treatment (Chow & Liu, 2013; ONeil, 2013).
Expenses
Because trials are complex, it would be important to consider expenses to be incurred in this phase. If the cost estimates would be high, then sponsors would be sought to fund the ambitious project. The phase III trials would commence after the required funds will have been obtained.
Approval
Phase III trials require approval from relevant clearance bodies. The drug will have to meet standard norms and guidelines so that it would be approved (De Angelis et al., 2005; Chow & Liu, 2013; ONeil, 2013).
The guidelines would specify manufacturing approaches and data that would have been collected during the pre-clinical and clinical trials. The rate at which the specified data would be availed to the approving body will greatly determine the speed at which the drug will be approved or rejected for clinical use.
Consumer response
The phase will also focus on marketing the drug to consumers, pending approvals from the relevant bodies. The responses from consumers about the pricing and side effects of the product will be studied. If a significant number of consumers would express safety concerns about the drug, then it would be essential to conduct further studies to assess the safety of the drug in patients (Chow & Liu, 2013). However, good responses from consumers would be an indication that the drug would have good sales in the future.
Phase IV
This phase would occur after the marketing phase. It would have the following considerations:
Pharmacovigilance
Technical support
Drug interactions
Aggressive marketing
Pharmacovigilance
When the drug is introduced into the market, it would be essential to continue conducting pharmacovigilance to assess whether it would continue providing patients with therapeutic benefits.
The study would be done in clinical fields and hospitals. Clinical data would be used to access important information about the safety of the drug. For example, if healthcare data will show that a significant number of patients would be found to have side effects associated with the drug, then it will be important to carry out studies to determine the causes of the undesirable effects.
Technical support
This consideration will focus on support in the manufacturing and distribution processes. Efficient manufacturing processes would lead to steady production that would ensure that the drug will always be available in the market for drug consumers. This consideration would also concentrate on how technical problems would be solved.
For example, the period that would be required to troubleshoot faulty equipment would greatly determine manufacturing efficiency. If long periods would be required to solve such technical problems, then it would imply that the drug might be out of stock, and its sales would be affected negatively.
Drug interactions
It is not possible to conduct drug-interactions involving all drugs in vitro. Therefore, the drug would be expected to interact with different drugs in patients. Some drug interactions could produce undesirable effects, which might be lethal. It would be essential to document the adverse effects that would be produced as a result of drug interactions (ONeil, 2013).
The documentation would help to include the information in the drug product information. Thus, users of the drug would be advised about the different classes of drugs that would not be used together with the recombinant drug.
Aggressive marketing
Pharmaceutical companies manufacture drugs so that they would sell them and make profits. Aggressive marketing will be launched to promote sales of the product. Different approaches will be utilized to market the biologic drug. Medical representatives will be hired to raise awareness of the drug among physicians and clinicians who would prescribe the drug to be used by their patients.
Medical representatives will also convince pharmaceutical distributors to purchase the drug in anticipation that its sales would increase significantly. Aggressive marketing will facilitate the rate at which the product will be sold and used by healthcare consumers. The marketing personnel will important in explaining the biological importance of the drug to clinicians, physicians, and consumers when conducting continuous medical education.
A critical appraisal
A critical appraisal on Wallentin, L., Becker, R. C., Budaj, A., Cannon, C. P., Emanuelsson, H., Held, C.,& & Harrington, R. A. (2009). Ticagrelor versus clopidogrel in patients with acute coronary syndromes. New England Journal of Medicine, 361(11), 1045-1057.
Coronary syndromes have been shown to cause many deaths across the world every year. The study aimed to assess the efficacy of ticagrelor in treating coronary syndromes. Specifically, a comparison was made to an established drug in the market that was being used to treat coronary syndromes.
The study findings will contribute greatly to the proposed study, which aims to understand and carry out clinical trials on ticagrelor. The study used 18,624 study participants who were enrolled in 43 countries in 2008. Important results were reported (Wallentin et al., 2009).
The group of patients that were treated with the new drug demonstrated lower endpoint than the group that was treated with clopidogrel. The difference was found to have statistical significance. This shows that the new drug showed better treatment levels because it treated the health condition through the application of a relatively smaller amount of the drug.
It was established that the two drugs showed a significant difference in physiological effect in the first month of treatment, a trend that continued throughout the study (Wallentin et al., 2009). The continued difference implies that it did not happen by chance, but due to pharmacological benefits associated with the two drugs.
In studies involving drug comparisons, it is always essential to show that one drug is superior to another by calculating the statistical significance of treatment variations. About adverse effects like death and recurrent ischemia, the new drug showed low chances of patients experiencing the effects (P<0.001). The following are the other conditions that were found to originate from vascular causes:
Stroke
Myocardial infarction
Transient ischemic attack
Arterial thrombosis
The rate at which patients in the two treatment groups suffered from stroke did not show significant variations. However, the group treated with ticagrelor exhibited more cases of hemorrhagic strokes (Wallentin et al., 2009). It could have been important to assess the causes of stroke in the treatment group by conducting more studies. Although the difference in the cases of stroke did not show statistical significance, it could raise concerns about the new treatment in the future.
It might be that the drug would cause more stroke cases in the future if it would be used continuously by patients. The assumption could be true because the period was not long enough to assess long-term effects of ticagrelor about strokes. It would be critical to conduct lengthy studies in the future that would determine the effects of the drug about hemorrhagic strokes.
The two drugs were also assessed in terms of efficacy in patients who were planning to undergo invasive treatment. The results showed that the group treated with ticagrelor was marked by lower rates of endpoint. Therefore, the results implied that ticagrelor could be used to save the lives of patients who were in danger following coronary complications. Hence, the drug could be recommended as an excellent treatment option for treating severe cases of vascular diseases (Wallentin et al., 2009).
The study established that the group that was treated with ticagrelor showed lower rates of thrombosis than the group that was treated with clopidogrel. That was an important observation because thrombosis is a common complication of the vascular system that affects people of different ages (Wallentin et al., 2009). The therapeutic benefit of the new drug could be assumed to prevent high blood pressure that is caused by the accumulation of fats on the inner walls of blood vessels.
The rigorous assessment of the 33 subgroups demonstrated that ticagrelor was attenuated in patients characterized by weight that was less than the recommended weight about their sex. The same observation was made for patients who were not taking drugs that could lower lipids at randomization, those who were recruited in North America (Wallentin et al., 2009).
Bleeding was another aspect that was studied in the two treatment groups. The bleeding that was defined in the clinical trial did not differ significantly with any of the two drugs. Also, in terms of major bleeding, the two drugs did not have a significant difference that could have resulted in myocardial infarction and thrombolysis. Another important observation that was documented was that all the 33 subgroups did not show differences in major bleeding.
Thus, the results were characterized by a high level of consistency. Such a level of consistency of observations is essential in clinical trials because it shows that a study is not characterized by confounding factors that introduce bias. Study findings that are not consistent cannot be used by researchers to impact evidence-based practices in the healthcare industry. On the other hand, findings marked by a high level of consistency can be repeated by independent researchers to produce the same results (Wallentin et al., 2009).
It was demonstrated that the two treatment groups exhibited the same rates of bleeding that would require transfusion of erythrocytes, but the ticagrelor group showed higher cases of bleeding that could not require transfusion. That was an important observation because the two drugs caused bleeding that could not require the replacement of red blood cells. However, it would be critical to assess the effects of bleeding associated with the use of ticagrelor. It could be that continued use of the drug would result in health conditions that would require a blood transfusion.
It was noted that ticagrelor (13.8%) produced more side effects than clopidogrel (7.8%). Adverse drug effects in the group treated with the new drug made study participants discontinue from the study (Wallentin et al., 2009). That was a recommended approach so that the observed adverse drug effects could not cause more harm to patients.
In conclusion, the use of ticagrelor appeared to have more therapeutic effects than clopidogrel. The new drug showed better rates of preventing death caused by coronary syndromes and myocardial infarction. Also, the drug did not cause bleeding that could require transfusion. Therefore, ticagrelor could save the lives of thousands of patients suffering from coronary syndromes. Further studies will need to be conducted in the future to assess the long-term efficacy and safety levels of the drug.
References
Chow, S. C., & Liu, J. P. (2013). Design and analysis of clinical trials: concepts and Methodologies. Hoboken, NJ: John Wiley & Sons.
De Angelis, C. D., Drazen, J. M., Frizelle, F. A., Haug, C., Hoey, J., Horton, R.,& & Weyden, M. B. V. D. (2005). Is this clinical trial fully registered?A statement from the International Committee of Medical Journal Editors. New England Journal of Medicine, 352(23), 2436-2438.
ONeil, M. J. (Ed.). (2013). The Merck index: an encyclopedia of chemicals, drugs, andbiologicals. London, United Kingdom: RSC Publishing.
Wallentin, L., Becker, R. C., Budaj, A., Cannon, C. P., Emanuelsson, H., Held, C.,& & Harrington, R. A. (2009). Ticagrelor versus clopidogrel in patients with acute coronary syndromes. New England Journal of Medicine, 361(11), 1045-1057.
Wang, R., Lagakos, S. W., Ware, J. H., Hunter, D. J., & Drazen, J. M. (2007). Statistics in medicinereporting of subgroup analyses in clinical trials. New England Journal of Medicine, 357(21), 2189-2194.
The issue of the significance and viability of generic medicines is being intensely debated in medical as well as political platforms given the massive difference in prices between generic and brand name drugs. The most noteworthy feature of the issue emerges from the fact that pharmaceutical companies invest millions of dollars in researching the effectiveness of new drugs and patenting them so that other companies do not use the name for their benefit. However, the patent lasts only for a given period (generally 10 years) after which other companies are free to make generic medicines with the same ingredients, albeit at much lower prices, as they do not incur costs on research, patenting, marketing and promotion. In essence, any drug that is made with the same active ingredients and with the same properties can be accepted as a substitute for the given brand name drug and can be prescribed by medical practitioners as a therapeutic equivalent. It is in this context that this paper makes a detailed analysis in determining the factors and chemistry that is involved in making generic brands less expensive in comparison to brand name drugs.
Main Body
It is important to note that it is possible to make generic medicines only in the context of brand names whose patent has expired. The production of generic medicines has been constantly increasing over the last few years given the massive cost savings they entail for both the producer and the patient. They prove to be cheaper by 20-90 percent in comparison to the brand name drugs having the same ingredients and properties (Dunne et al). In essence, generic drugs are not hazardous in any way and can be used as safe alternatives for brand name drugs (Mitchell). They prove to be less costly for both the government and consumers, which is apparent from the fact that they comprised 70 percent of the total medicines sold in the US in 2016. Consequently savings of over $800 billion accrued on account of the practice in the last ten years (West). In the US and most parts of the world, generic drugs are sold after the patent on the equivalent brand name drug expires. Hence, there are massive savings for consumers.
Generic drugs are approved by the FDA in the US only if they have the same active ingredients and require to be given in the same dosage and through the same mode of administration as the brand name drug. They have to also be bioequivalent with the brand drug, which implies that they work on the human body with the same effect, without creating any hazards. In essence, generic drugs are made with the same chemistry, manufacturing, testing processes, labeling, and inspection processes as brand name drugs. The only difference is that they do not require undergoing clinical studies or animal studies as they satisfy the need to be bioequivalent with brand name drugs. Also, companies making generic medicines mostly do not add to their costs as they generally do not involve in the promotion and advertising (West).
According to Mongolian and Myrdal, it is extremely complicated and costly to develop a new drug and to get FDA approval for the same because pharmaceutical companies have to often struggle for years in researching the biochemistry of varied diseases such as cancer, malaria and viral infections to develop viable treatments for them. The drug has to be also tested for efficiency, toxicity, and other aspects of animals. Such processes continue for years and once indications emerge about the drugs success on animals, it is tested on humans. Mongolian and Myrdal estimate that the cost of developing one new drug works out to be over a billion dollars and the development process usually takes over ten years. The high prices associated with brand name drugs are an outcome of efforts of such pharmaceutical companies to recover their investments during the period that the patent for the drug remains in force.
Vivian has provided a meaningful understanding of how to make the best of generic drugs without any involvement of risk. He asserts that upon discovery of a drug, it is identified with a chemical name that indicates its molecular or atomic properties. Upon approval of a drug, the FDA first gives it a generic name, after which the pharmaceutical company making the drug gives it a brand name. In the US, the generic name of drugs is given by the United States Adopted Names (USAN) Council. The brand name as given by the company manufacturing the given drug becomes its sole property. Consequently, a generic drug can be sold under a brand name or its generic name as given by its producer. Vivian has aptly explained the difference between generic drugs and brand name drugs by relating them with their respective chemical properties, which are depicted in the following diagram:
Diagram 1: Difference between Generic Medicines and Brand Name Drugs. Source: Vivian, Eva M. Overview of Generic Drugs and Drug Naming.
In the US, the FDA has set minimum standards for generic drugs in terms of the performance and quality that is associated with brand name drugs. The US Food and Drug Administration has held that all generic drugs approved by it bring the same outcomes as brand name drugs. It has cited research in stating that A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand name heart drugs worked any better than generic heart drugs (US Food and Drug Administration). The fact remains that the FDA does not permit a difference of more than 3.5 percent in the absorption results of generic drugs about their brand name counterparts. The difference in chemical properties to the extent of 3.5 percent is acceptable as it does not make any difference in the outcome of the drug. At the same time, just because generic drugs are cheaper it does not mean they are of lower quality. They are cheap only because manufacturers save on research, advertising, and promotion costs. Khandelwal argues that it is because of marketing and promotion activities of pharmaceutical companies producing brand name drugs that branded drugs are popular. On the other hand, generic drugs are sold in keeping with their scientific names, which are not commonly known to people. However, the low prices of generic drugs are gradually attracting larger numbers of people who have no issues in making the extra effort to locate them based on their ingredients.
Conclusion
It is apparent from the analysis that generic drugs have come to stay in providing consumers with options to buy drugs at much lower prices than brand name drugs. In making new drugs, pharmaceutical companies have to incur heavy costs on research and development of the product in ensuring that they have no adverse consequences to human beings. Such efforts involve research over long periods on animals, after which they are tested on human beings to determine their effectiveness in relieving and curing the given diseases. Once the properties of a brand name drug are ascertained in terms of its efficacy in curing a disease, the pharmaceutical company patents the drug so that it enjoys the sole rights to sell it. In addition to the costs incurred on R&D, the brand owner invests heavily in marketing and promotion, which is why such drugs tend to be priced high. However, once the patent for the brand name drug expires (after about 10 years) it can be produced by other companies under different names but with the same ingredients at much lower costs, thus allowing them to sell the drug at lower prices than the brand name drug. In the US, the FDA has no objection in approving generic drugs as long as they meet the same requirements as to brand name drugs. It thus emerges that there is no difference in the efficacy of generic drugs except that they are available at lower prices only after the patent for the drug has expired.
Works Cited
Dunne, Suzanne, et al. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. Bio Med central. Web.
Three articles were evaluated to assess and determine whether topical NSAID treatment can lower the pain for acute injuries. The first article from Hocking, Robertson, and Gentle (2005) involved the influences of NSAIDs regarding pain from acute injuries. The research aimed at identifying the working dosage of the drugs namely flunixin, carprofen, ketoprofen, and sodium salicylate.
The variations from the normal body functioning of a domestic fowl were used to evaluate the effectiveness of each drug. The measurements were monitored for an hour starting from 60th minutes after injection of the drugs. Sodium salicylate was the most ineffective drug since high doses did not normalize behaviors. The optimum dosage for the remaining three drugs was 1:10:4 regarding flunixin, carprofen, and ketoprofen respectively.
The second evidence from Ziltener, Leal, and Fournier (2010) involved the strategy of care provision to athletes. The researchers argued that there is no adequate support and directions on the application of NSAID. They indicated that the negative effects of these drugs were prevalent especially for long-term resolutions. The use of these drugs in cases of muscle injuries and bone fractures required high doses. Their research was specific to the athletes who were the main agenda of the effectiveness of NSAID in the original question. The researchers concluded that the clinicians needed to determine the right and suitable drug for use depending on the category of pain, nature of the injury, and level of pain.
Finally, the research conducted by Kvien and Viktil (2003) on therapy in regional musculoskeletal pain (RMP) nature appears at various levels. Therefore, these differences imply that the aid assistance issued must also be distinct. The researchers argued that analgesics are related to risk side effects. On the other hand, the efficiency of topical NSAIDs has been evaluated severally about the RMP. Assuming that the COX2 inhibitors will not depict any apparent differences from COX, the NSAIDs are considered risky.
Evidence Summary
It is not apparent whether the use of NSAIDs has a satisfactory and reliable basis of application in clinical practices. The use of these drugs requires further evaluation before recommendation to the patients. Research has shown that these drugs can be used in relieving mild pain such as headache and fever only. Acute pain may demand the introduction of unreasonable amounts of these drugs into the system leading to health problems for the patient.
Acute injuries require specialized drugs selected and approved for their purpose. High doses of NSAIDs reduce their efficacy and null down their purpose. Furthermore, the drugs may fail to work effectively even when used at high content. Hocking, Robertson, and Gentle (2005) show that the NSAIDs have varying effects that may require adequate evaluation to approve their use. Ziltener, Leal, and Fournier (2010) pointed out that there is no reliable literature to define the standard use of the drugs for acute pain implying that the use of these drugs is not warranted.
These arguments are supported by Kvien and Viktil (2003) who propose and confirm that NSAIDs may be unreliable especially due to their drug side effects. All three articles drive at discouraging the use of NSAIDs and revealing the doubts available regarding their application. These attributes imply that the NSAIDs are not reliable and allowed drugs for reducing the pain from acute injuries such as musculoskeletal pain. However, adequate and reliable research information has not been followed in the entire sources.
The first and second sources are strong for handling many experiments and designing them to provide results that cannot be modified by errors in sample size. However, the last research was the center of an assumption that creates a lack of certainty in the conclusions. In this regard, it can be argued that COX2 may be different from the COX and thus lead to differences. The use of these drugs might cause harmful effects that are hazardous to the smooth functioning of the human body. They ought to be removed and evaluated for efficacy by all means possible.
The NSAIDs have not been chosen for therapy of pain-relieving. Treatment of acute pain demands the application of other named and legalized drugs. NSAIDs have lethal reactions that may cause abuse and dependency dictating why the clinical practices must avoid them. In this regard, evidence-based practices assist practitioners to identify the relevant literature and choose the best ways to serve the patients. Essentially, this aspect functions under the assistance of the current researchers performed through reliable strategies and approved as reliable documents of the review.
References
Hocking, P., Robertson, G., & Gentle, M. (2005). Effects of non-steroidal anti-inflammatory drugs on pain-related behaviour in a model of articular pain in the domestic fowl. Research in Veterinary Science, 78(1), 69-75.
Kvien, T. K., & Viktil, K. (2003). Pharmacotherapy for regional musculoskeletal pain. Best Practice & Research Clinical Rheumatology, 17(1), 137-150.
Ziltener, J., Leal, S., & Fournier, P. (2010). Non-steroidal Anti-inflammatory Drugs For Athletes: An Update. Annals of physical and rehabilitation medicine, 53(4), 278-288.
Artesunate is an antimalarial drug for injection, artemisinin derivative, and is used to treat malaria in patients of various ages. The effective action of Artesunate is supported by its advantage of a hydrophilic group (Khanal, 2021). Artesunate is a first-line treatment followed by an entire course of malaria treatment.
Mechanism of Action
Artesunate metabolized into dihydroartemisinin (DHA), which contains the endoperoxide bridge responsible for combating Plasmodium falciparum, a parasite that causes malaria. DHA reacts with heme resulting in free radicals, which inhibit proteins and nucleic acid synthesis.
Drug Administration and Dosage
Artesunate is supplied as a white powder for further dilution with sterile diluent and production of a colorless solution. Recommended doses of Artesunate are 2.4 mg per kg of body weight for adults and children are heavier than 20 kilograms, and 3 mg per kg for children less than 20 kilograms (Kitabi et al., 2021). The drug is administered intravenously at 0, 12, 24 hours, and after that daily.
Drug Interactions
The drugs ritonavir, nevirapine, or UDP-Glucuronosyltransferase (UGT) inducers may reduce the antimalarial effects of Artesunate (FDA, 2020). UGT Inhibitors can enhance the side effects of Artesunate drug action. These aspects need to be monitored with the simultaneous use of Artesunate injections and mentioned drugs.
Potential Side Effects/Adverse Effects/Toxicities
According to FDA (2020), clinical trials of Artesunate drug have identified potential side effects and adverse reactions:
hemoglobinuria;
acute renal failure requiring dialysis;
jaundice;
anemia;
thrombocytopenia;
lymphopenia;
neutropenia;
pneumonia;
diarrhea;
elevated creatinine;
pulmonary edema;
pyrexia;
abdominal pain;
vomiting;
dizziness;
headache;
cough.
Lab Effects/Interference
Clinical studies tested the efficacy and safety of the Artesunate drug. Two studies found that compared to another broadly used antimalaria drug quinine, Artesunate reduces mortality rate and the risk of hypoglycemia (Khanal, 2021). Another study expanded the understanding of drug action by proving less risk for patients to have coma and convulsions. A clinical trial comparing Artesunate with artemether also showed less mortality rate and faster recovery with Artesunate.
Special Considerations
In the case of a sensitive reaction to a drug, such as dyspnea or rash, it is necessary to consider the possibility of treatment with another drug. After Artesunate treatment, patient follow-up monitoring is needed to identify possible hemolytic anemia. Clinical trials have not identified threats to the mother and fetus during pregnancy, as opposed to the severe risks of delayed malaria treatment.
Nursing management
The healthcare practitioners first assess the needs or possible treatment of severe malaria by Artesunate drug. The preparation of the solution from the powder must be carried out using the diluent supplied. The nurse should take 11 ml of diluent with a needle to add to the powder and swirl until all the powder is completely dissolved. The drug is recommended to be administered as a slow bolus during 1-2 minutes. It is recommended to store the medication at room temperature, not freeze, not heat, and avoid light ingress. Health care providers must not use the medicine after the expiration date.
Patient Assessment
Artesunate is for malaria patients only after a confirmed diagnosis. The patient assessment goes through a physical examination and evaluation of symptoms, as well as a laboratory test. A specialist may prescribe a microscopic blood test to detect parasites or an antigen test. Additional tests may be needed to detect side effects and take measures to mitigate them.
Patient Education
Patients with malaria who are prescribed Artesunate should be aware of its mode of administration and duration of treatment. Patients should discuss with the medical provider such considerations as the presence or absence of allergies, kidney disease, pregnancy, and the current use of any drugs. Patient education should also include knowledge of potential side effects and reactions and cases that need to be reported. If there is an allergic reaction, it is worth considering alternative treatments and stopping the Artesunate use.
Khanal P. (2021). Antimalarial and anticancer properties of artesunate and other artemisinins: current development. Monatshefte fur Chemie, 152(4), 387400. Web.
Universal healthcare in the United States guarantees that all citizens have access to the medical care they need, regardless of their capacity to pay. Despite President Obamas many sacrifices to implement the Affordable Care Act, his administration was instrumental in achieving this goal (Kirk et al.). During the Obama administration, the insurance and pharmaceutical sectors were adamant about the concept of universal healthcare, and he was forced to make concessions to secure its implementation. It established the basis for ensuring that all United States residents have access to inexpensive and accessible healthcare regardless of their financial circumstances, which has yet to be fully realized.
How the Pharmaceutical Industry Affected Bidens 2021 Build Back Better Bills Failure
People with Medicare and private insurance will pay less for their prescription medication due to the provisions included in the Build Back Better Act. This initiative was not well received by the pharmaceutical drug business, which is why the bill was opposed (Nawaz and Cuevas). It resulted in an overall reduction in the influence that the federal government and other significant payers would have on the amount of money spent on pharmaceuticals. Consequently, the bill was ineffective in ensuring that the measures for reducing the cost of medications were fully implemented, which led to its failure.
Conclusion
Congress is responsible for enacting bills into laws that benefit American citizens. As a result, they should be objective in adopting regulations that benefit residents and should not be influenced in any way. It is not always the case, as certain congress members are sponsored by various economic stakeholders, such as pharmaceutical corporations, which have a particular interest in policymakers. As a result, they impact Congresss policies by ensuring that only favorable laws are passed. Due to this, successive administrations, including Obamas and Bidens, have struggled to implement fair laws promoting universal healthcare due to lobbying from interested parties such as pharmaceutical corporations.
Works Cited
Kirk, Michael, et al. Obamas Deal.PBS, Public Broadcasting Service, 2015, Web.
Mental illness is described as the behavior exhibited by individuals who are not in their normal states of mind (Goldberg 204). As a result, there is need to restore the normal state of mind. Medical practitioners have resorted to the use of drugs in treating symptoms associated with mental disorders. The drugs are aimed at altering the patients state of mind through the modification of physiological and chemical processes executed by the individuals central nervous system. The drugs are commonly referred to as psychotherapeutic drugs. The drugs achieve their intended purpose by interfering with nerve impulses. When used appropriately, psychotherapeutic drugs assist individuals suffering from mental disorders to achieve the right mental state under controlled conditions. Psychotherapeutic drugs, however, pose serious health risks to an individual when abused . In severe cases , they may permanently alter brain processes. In addition, addiction arises from abuse of the drugs.
The paper aims at fully understanding the term mental illness. In addition, the relationship between mental illness and medicine is discussed. The issue of increased susceptibility to mental illness among certain groups is also tackled. Finally, types of mental disorders are discussed towards the end of the paper.
Mental Illness
Mental illness is the term used to refer to the abnormal state of mind characterized by psychological patterns and usually associated with distress (Kinderman and Lobban 308). Benjamin Rush, an American physician, simply describes the condition as an illness of the brain. The condition is brought about by a disease affecting the brain. Chemical imbalances in the brain is another major cause of the condition. Psychologists describe the abnormal state of mind as inappropriate thinking and conduct in an individual. However, confusion arises when determining the right definition of the term inappropriate.
Despite the presence of many definitions attempting to describe the condition, it is clear that mental illness is brought about by malfunctions of parts of the brain or the entire nervous system. The nervous system is a mass of neurons connected to each other (Pilgrim and Rogers 78). Defects in a single neuron will in turn affect the entire nervous system. Psychotherapy and psychotherapeutic drugs are the only known forms of treatment for the condition. Psychotherapeutic drugs are aimed at reducing the effects of the condition, enabling the individual to lead a normal life as long as the prescribed medication is adhered to. Sedatives and tranquilizes are the most commonly used drugs when dealing with psychiatric cases.
Mental Illness and Medicine
Medical practitioners are charged with the responsibility of diagnosing cases of mental illnesses among patients. Mental illnesses have two major causes identified by medical practitioners. The causes are chemical imbalances in the brain and a disease affecting the brain or the nervous system (Goldberg 204).
A pathogen transmits the disorder when the mental illness is caused by a disease affecting the brain. The concept is commonly referred to as the medical model. The treatment or prevention of the disease associated with mental illness will translate to the treatment or prevention of the mental illness. In such a case, mental illness is described as a disease with symptoms. It is a disease with a cure (Kinderman and Lobban 308). Psychotherapeutic drugs aimed at treating the mental illness are administered to the patient to facilitate recovery. The psychotherapeutic drugs target specific symptoms exhibited by a mentally ill patient . They aim at suppressing the effects of the condition. The drugs achieve this by initiating or inhibiting brain processes.
Critics feel that administration of drugs to treat behavior is inappropriate. The argument is based on the opinion that mental illness is just an inappropriate state of mind and is not necessarily caused by a disease. People have different ways of dealing with pressure and stress, and their reactions should not be construed as a mental illness (Pilgrim and Rogers 78). Medical practitioners face difficulties distinguishing between appropriate and inappropriate behavior.
Thomas, a critic of the medical model, is of the view that mental illness is just a myth. He further argues that drugs should not be administered to those identified as mentally ill since drugs are intended to treat specific ailments, not behavior. As a result, psychologists have a hard time diagnosing cases of mental illness in a population.
Difficulties associated with the diagnosis of mental illnesses pose a major challenge to the determination of the right drug to administer to patients. Psychotherapeutic drugs administered in cases of mental illnesses are aimed at treating the symptoms exhibited. Such a mode of treatment is aimed at suppressing the effects of the mental illness on an individual. Critics say that little is achieved through the administration of the drugs since treatment is only concerned with the symptoms, rather than the root cause of the mental illness.
Treatment of symptoms in a mental patient translates to the suppression of the effects of the illness. As such, the behavior of the patient is controlled as long as they adhere to the prescription specified by the medical practitioner. Therefore, psychotherapeutic drugs are aimed at treating the symptoms, rather than curing the mental disorder. As a result, they must be administered from time to time.
Mental Illness and Special Population
Statistics show that all groups of people are susceptible to mental illnesses. Cases of mental illnesses are reported among people from all walks of life. The condition is, however, more common among adolescents between the ages of 16 and 17 years compared to other groups of people (Goldberg 204). Close to 12 percent of individuals in this age group exhibit instances of depression. In addition, research has shown that more than half of adults suffering from mental illnesses started exhibiting the symptoms when they were still young.
Researchers and medical practitioners have attributed the rising cases of mental illnesses among adolescents to unfavorable family backgrounds and relations. Build-up of stress as a result of these conditions leads to depression. Depression alters the behavior of a person. Psychotherapeutic drugs are administered to these individuals to suppress the diagnosed symptoms. Out of all the drugs available, sedatives are the most appropriate in this case since they have a calming effect on users (Kinderman and Lobban 308).
Postpartum mothers are more vulnerable to mental illnesses compared to other women (Goldberg 205). The group is reported to experience episodes of depression in the period just after birth. The symptoms can extend up to twelve months after birth. Research has shown that young women have a high risk of experiencing postpartum stress compared to older mothers. The severity of postpartum stress is aggravated by partner-related stress and relationship wrangles, such as cases of physical abuse by partners. In addition, the elderly people in the society are more susceptible to mental illnesses compared to young adults (Goldberg 205). The group is made up of people aged fifty years and above.
The three special groups account for the largest number of mentally ill persons in the society. Cases of suicide among individuals in these groups is on the rise. Provision of psychotherapeutic drugs to the three groups will go a long way in winning the fight against mental illnesses. The drugs should be made available to these groups.
Types of Mental Disorders
In some cases, mental disorders are associated with emotional problems. Victims are not in a position to distinguish between mere imagination and reality (Goldberg 204). The patients experience unrealistic fears and anxieties. Mental disorders include anxiety and psychosis.
Psychosis occurs when the individual is not in a position to differentiate between reality and mere speculation. The disorder is divided into two categories; organic and schizophrenia. Organic psychosis is brought about by physical factors, such as drug and substance abuse, as well as neurological diseases. Psychotherapeutic drugs applied in such cases are aimed at treating the effects of the physical causes of the condition. On the other hand, schizophrenia affects an individuals personality. It may lead to multiple personality disorder among individuals. Psychotherapeutic drugs are applied to alter behavior in cases of schizophrenia. Sedatives, for instance, are used to induce calmness. As a result, they reduce cases of violent behavior among mentally ill patients (Pilgrim and Rogers 78).
Patients suffering from anxiety experience abnormal fears. Their life is full of worries, leading to distress and restlessness. Psychotherapeutic drugs used in such cases are mainly sedatives, which are aimed at calming the patient. When used in low doses, sedatives reduce anxiety levels among patients, calming them down (Goldberg 204). High doses sedate the patient. The high doses may be used to induce sleep in a patient when the need arises.
Conclusion
Psychotherapeutic drugs are used to help individuals suffering from mental illnesses attain the right mental state. Sedatives and tranquilizers are the two major types of drugs used in the treatment of psychiatric conditions. Other types of drugs used in psychotherapy include, among others, antidepressants, pain killers, depressants, and stimulants. However, the patient should strictly adhere to the prescribed dosage to attain the desired effects without putting their health at risk (Pilgrim and Rogers 78).
Psychotherapeutic drugs pose serious health risks to users when abused. They may permanently alter brain processes (Goldberg 206). In addition, abuse of these drugs may lead to addiction. Individuals using sedatives and tranquilizers have reported cases of addiction, where they become habitual users of the drugs.
Works Cited
Goldberg, Raymond. Drugs Across the Spectrum, Belmont: Wadsworth, 2010. Print.
Kinderman, Peter and Fiona Lobban. Evolving Formulations: Sharing Complex Information With Clients. Behavioral and Cognitive Psychotherapy 28.3 (2005) 307310. Print.
Pilgrim, David, and A. Rogers. A Sociology of Mental Health and Illness, New York: Open University Press, 2005. Print.
