Historically, pediatric drugs have been used without the adequate research done for pediatric formulation and dosage information for children usage. There have been difficulties and lack of pediatric trials done on drugs and children received unapproved therapeutic uses based on adult formulation, which have caused harmful results in children. There is a profound need for pharmaceutical tests to be approved for safety and effective for use by children. Only few drugs have adequate labeling information and approved indication for dosage, frequency, and route of administration. However, over the recent years, implementation of pediatric regulations and legislations have been initiated and review committees have been established to renew this issue. #2 In order to improve the health of children, both FDA and EMA established several regulations to ensure the safety and efficacy of pediatric medicines. The FDA established the Pediatric Labeling Rule in 1994 and later finalized into the Pediatric Rule in 1997 to ensure adequate pediatric labeling and to require manufacturers of new drugs to submit safety and effectiveness information for approval. Under, the Food and Drug Administration Modernization Act (FDAMA), FDA also issues a Written Request (WR) to pharmaceutical companies for pediatric studies of certain drugs with incentives. Through the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), FDA continue to request pediatric studies and the data to be presented one year after the study conduct. The EMA established its pediatric regulations in 2006. It includes the Paediatric Committee to help oversee the pediatric medicines. EMA’s regulation requires new products and certain changes... ... middle of paper ... ...e forms for children lags behind that of their adult counterparts. The main challenges are solubility, stability, taste masking, and appropriate selections of excipients and packaging material. For example, a problem rests in the use of tablets and capsules that lack dosing flexibility. Tablets and capsules are usually not created or dosed for children and thus adult tablets and capsules are modified by compounding. However by grinding the tablet and sprinkling it into fluid or a food vehicle usually results in dosing variability from one administration to the next. Taste is also a major problem for pediatrics. Alot of the time children do not like the taste of non-masked formulations. There are many physiological and pharmacokinetic differences between adults and children. As technology advances, it will become easier to research and create pediatric formulations.
There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children.
There is a great deal of controversy surrounding the issue of children being medicated with powerful psychotropic medications. Psychological disorders, such as bipolar disorder, that were once believed only to effect adults, are now being diagnosed in children, and those children are, more often than not, now being treated with medications. The number of children being diagnosed and treated with psychotropic medications has rapidly increased in recent years. A report issued by Medco Health Solutions in 2010 states that the number of children being prescribed psychotropic medications doubled from 2001 to 2010. Psychotropic medications can be defined as "any medication capable of affecting the mind, emotions, and behavior"(medicine net). The classes of psychotropic medications are; Stimulants, such as Adderall- prescribed for Attention Deficit Hyperactivity Disorder, Antidepressants, such as Prozac- prescribed for depression, Anti-psychotics such as Haldol - prescribed for behavioral disorders, and Mood Stabilizers, such as Depakote - prescribed for bipolar disorders. These medications have been shown to "stunt growth, cause obsessive behaviors, suppress spontaneity, and cause children to become depressed and less social"(Breggin, 2009). This paper will discuss what research suggests about the potentially negative effects of these medications on a child’s physical, cognitive, and socioemotional development. In addition, this paper will also examine the potential reasons these medications are increasingly prescribed, and alternative treatments for some of the psychological disorders that these kinds of medications are prescribed for.
Psychotropic medications, also referred to as psychiatric or psychotherapeutic medications, are used to treat psychiatric disorders, such as: depression, bipolar disorder, schizophrenia, anxiety disorders, and attention deficit-hyperactivity disorder (ADHD). They have been used for many years and oftentimes come with dangerous side effects. The side effects that often occur in children taking these medications can include: fainting, blurred vision, vomiting, extreme weight gain, and even death ("Seroquel information,” n.d.). The use of psychotropic medication to treat mental disorders in children and adolescents is highly controversial because of ethical viewpoints (i.e. parents “drugging” their children to calm them down) and potentially harmful side effects, but one has to take into consideration whether the risks outweigh the benefits when deciding whether or not to give this type of medication to children.
...ve physical deformities, decreased birth weight and respiratory difficulties. The drugs can also carry adverse behavioral effects, including high pitched crying, abnormal sleep patterns and decreased attention. Studies have determined that some infants can rectify these behavioral inconsistencies, but that the change is dependent upon a responsive caregiver in a nurturing environment.
A steep rise in the past ten years is shown in the diagnoses and medicating childhood disorders and more specifically bipolar disorder. An initial dose is given to a child to stabilize a psychological disorder. I turn this one drug cause the need for more drugs due to side effects. New medications are then used in order to reduce new side effects. The problem is the use of numerous medications in childhood diagnosed bipolar disorder. Many issues arise due to a lack of research on childhood medication use by the FDA, difficulty in proper diagnoses of bipolar disorder, and over medicating children. The video, “The Medicated Child”, explains the many issues faced in proper diagnoses of childhood mental illness and proper treatment to include medications.
Some facts about psychiatric drugs for children are that the drugs are prescribed with a false diagnosis. The children that are prescribed are not seriously impaired by their symptoms, they are merely becoming older and showing signs of adolescents; however, pediatricians see a small frustration in a child’s life and convince the parents or legal guardians that they need unnecessary medications to make the children docile and untroublesome. Little do the parents know, the drug given to the children means more money for the pharmaceutical companies and psychiatric research teams and may not even help the children at all.
Changing or stopping your child’s regular medicines. This is especially important if your child is taking diabetes medicines or
McMillan, Julia A., Ralph D. Feigin, Catherine DeAngelis, and M. Douglas Jones. Oski's Pediatrics, Principles & Practice. Williams & Wilkins, 2006.
The Medication Administration Accuracy Project is a quality improvement project, whose purpose is to improve the accuracy of nursing medication administration. The study used for this project was to find where the most common “wrong doings” happened in the medication process and how to get rid of it. After a year of this project the medication error percent went from 4.3% in 2010 to 1.2% in 2011. The Bar Code Administration System implementation had been very successful with a 95% success rate every year that it is done. The study provided important insight on reducing the medication errors in children. Some were: making sure there are no distractions as possible, double checking medications and making sure the dose in adequate range for the child, and making sure you have two ways of identification with the bar code scanning (Hardmeier, A., Tsourounis, C., Moore, M., Abbott, W., Guglielmo, J.
The off-label use of any approved drug relates to the use not included in the official label. The exclusion of uses for a specific disease or disorder from the official label proves that drug creators have not submitted the needed evidence, required by law to allow admittance, to the Food and Drug Administration. When this occurs, the statement, “safety and efficacy in pediatric patients have not been established” is printed in the product label. Randall Stafford M.D. writes, “Although off-label prescribing, the prescription of a medication in a manner different from that approved by the FDA is legal and common, it is often done in the absence of adequate supporting data. Off-label uses have not been formally evaluated, and evidence provided for one clinical situation may not apply to others” (Sta...
Today, a full 61 percent of adults use at least one drug to treat a chronic health problem, a nearly 15 percent rise since 2001. In today’s society doctors around America are abusing the privilege to prescribe medicine. This then causes the issue of overmedication. Americans who are being prescribed drugs that are not needed for them have more risk of side effects. The long-term effects are dangerous and have caused numerous children hospitalized. Americans who are buying treatments for ADHD, depression, and many more disorders have spent over 4 billion dollars in the past year. Prices are increasing because the desires for these drugs are becoming more prevalent. Overmedication is a global issue that is affecting children that come from many different backgrounds and live in many different areas in America.
risk, for drugs and medical devices, weighing risks against benefits is at the core of
& Treatment Of Children (ETC) 20.3 (1997): 281. Academic Search Complete. Web. 1 Mar. 2015.
Physiologic processes that influence pharmacokinetic variables in the infant change significantly in the first year of life, particularly during the first few months. Therefore, special attention must be paid to pharmacokinetics in this age group. Pharmacodynamic differences between paediatric and other patients have not been explored in great detail and are probably small except for those specific target tissues that mature at birth or immediately thereafter (e.g., the ductus arteriosus)