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 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.
FDA have been modified completely since 1906. The market itself, the science behind it, and the
...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.
Medicating our children for problems such as; Attention Deficit Hyperactive Disorder, bipolar disorder, or autism seems to be a new trend. Unfortunately, these medications have very dangerous side-effects especially in sensitive children like those in foster care. Healthy alternatives are often overlooked for a quick fix pill. Do parents even know what these medications do? Do they know what these medications were originally for?
You have been asked to design an oral liquid formulation of ibuprofen for paediatric use.
McMillan, Julia A., Ralph D. Feigin, Catherine DeAngelis, and M. Douglas Jones. Oski's Pediatrics, Principles & Practice. Williams & Wilkins, 2006.
When administering medications it is critical to pay great attention to the task at hand. This task becomes more important when administering medications to the elderly because of the different physiological and psychological changes that occur in the body. Equally important are, the lab values related to the medications being administered, differences in administering medications to the elderly, and the use of the six rights and three checks.
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
The ability to become reflective in practice has become a necessary skill for health professionals. This is to ensure that health professionals are continuing with their daily learning and improving their practice. Reflective practice plays a big part in healthcare today and is becoming increasingly noticed.
• Take or apply over-the-counter and prescription medicines only as told by your child’s health care provider. This includes any antihistamines.
There are many possible theories that can pertain to the idea and concept of drug treatment programs. The first theory that applies to effective drug treatment is the labeling theory. The labeling theory suggest that self identity and behavior of an individual is may be determined by how others classify or describe them. Drug use had a stigma that follows it. If you are doing drugs, you are considered a junkie, drunk, crack whore etc. When you are labeled you tend to believe and act in that way. The person takes on the identity of what others are labeling them. When building these programs, the stigma and labeling has to be eliminated. These patients like any other are looking for help and want to improve their lives. Labeling them will only
FDA set up the offices of Orphan Product Development in 1982 to focus on drugs, medical devices, foods for medical purposes, and biologics such as immune globulin for rare disorders. President Reagan signed the Orphan Drug Act into law on JAN. 3 1983. It guarantees the developer of an orphan drug seven years of market exclusivity and 50 percent tax credit for certain clinical research expenses. Imagine Pepsi or Coke having a monopoly on each other's soft drink, that would be the equivalent on that. Initially, the act app...
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)
• Handwriting interpretation errors are estimated to cause 9% of all medication errors. Although electronic prescribing (e-Rx) is finally well underway in the United States, it has for several years been the norm in many European countries. As recommended by the federal government and other national health care improvement organizations, the use of electronic prescribing applications in pediatric practice should be encouraged. The Institute of Medicine has recommended that all prescriptions be written electronically by the year 2010. It is estimated that 20% of U.