Monkey Drug Trials Experiment

Title: Monkey Drug Trials Experiment Authors: Deneau, Yanagita & Seevers Year: it was done in 1969 Purpose: The purpose of the experiment was to look at the effects of self-administration on drugs, drug abuse, and drug dependence in humans, by testing it on monkeys. They wanted to observe whether a monkey would become addicted to […]

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Daphnia Dissection

Table of contents

Abstract

This experiment is designed to find out how drugs affect the heart rate. This experiment will use Daphnia in order to monitor the effects certain drugs have on heart rates. I will observe the changes in the heart rate of Daphnia when exposed to Caffeine, Ibuprofen, Alcohol, and Nicotine. I will have several separate samples of Daphnia in my study. Each community will be exposed to a different drug and observe how the heart rate of the Daphnia changes accordingly. I believe the Daphnia heart rate will increase when the Daphnia are exposed to Caffeine and Nicotine because both of these drugs are stimulants. I believe the Daphnia heart rate will decrease and slow down when the Daphnia are exposed to Ibuprofen and Alcohol. This experiment will show not only the effects of these drugs on Daphnia but also what they similarly do to the human body when it is exposed. Daphnia is used as a humane alternative to Humans when performing this type of experiment. The results on the Daphnia will be very similar to how the human heart would react if exposed to these drugs. Key Words Nicotine Alcohol Caffeine Ibuprofen Effects of Drugs Daphnia Magna Heart rate Drugs Heart Introduction My experiment deals with the effects of different drugs on the heart rate of daphnia. I will focus on the daphnia’s body itself first.

Then I will give information pertaining to the drugs used: Caffeine, Ibuprofen, Alcohol, and Nicotine. Daphnia is small crustaceans that live in the water. They are commonly called water fleas. Daphnia is freshwater zooplankton and consumes phytoplankton and some other zooplankton as well. The daphnia’s bodies are transparent and their internal structures can easily be seen. The heart is the internal organ I focused on within the daphnia. The heart can be easily seen within the body cavity of the daphnia which made it easy to find and easy to count the heartbeat. Caffeine is a very important drug to consider because 90% of American consumes caffeine on a daily basis. Half of all Americans consume more than 300 mg of caffeine a day which makes it America’s most consumed drug to date. Caffeine is found in coffee, soda, tea, chocolate, etc. Caffeine is known as trimethylxanthine in the medical community. Caffeine can be used as a cardiac stimulant and also as a mild diuretic. Cardiac stimulants increase the heart rate, and diuretics increase urine production. Caffeine is a very addictive drug and operates just like amphetamines such as cocaine and heroin.

Caffeine not only stimulates the heart of humans but also the heart of daphnia. Ibuprofen is commonly used to relieve pain, tenderness, swelling, and stiffness caused by arthritis. It is also used to relieve mild to moderate pain in the body and reduce fever. Ibuprofen is called an NSAIDs. It works by stopping the body’s production of a substance that causes pain, fever, and inflammation. Ibuprofen is most often used to treat arthritis. Alcohol is often used as a solvent in medical drugs, because of its low toxicity and ability to dissolve non-polar substances. Ethanol is often used as an antiseptic, to disinfect the skin before injections are given. When processed correctly Alcohol is drunk in recreation. Alcohol affects the body as a nervous system depressant (Wong 1997). Nicotine like caffeine is a stimulant. This stimulant is found in cigarettes. Cigarettes contain 8 to 20 milligrams of nicotine but when smoke only 1 mg of nicotine actually enters the body. Nicotine can have two effects on the body, it can relax a person or it can stimulate a person, this is based on the amount and the regularity of smoking or nicotine intake.

Nicotine works by causing a release of adrenaline into the body. Statement of the Problem How do certain drugs affect heart rate? Objective/Hypothesis Statement This experiment is designed to find out how drugs affect heart rate. This experiment will use Daphnia in order to monitor the effects certain drugs have on heart rates. I will observe the changes in the heart rate of Daphnia when exposed to Caffeine, Ibuprofen, Alcohol, and Nicotine. I will have several separate samples of Daphnia in my study. Each community will be exposed to a different drug and observe how the heart rate of the Daphnia changes accordingly. i. e. Foster 1997 I hypothesize that the Daphnia heart rate will increase when the Daphnia are exposed to Caffeine and Nicotine because both of these drugs are stimulants. I hypothesize the Daphnia heart rate will decrease and slow down when the Daphnia are exposed to Ibuprofen and Alcohol.

I used a modified version of the experiment performed by Jasmine Kamai and Varner Allbrett when they studied the effects of Kava on the heart rate of Daphnia. My procedure is as follows: Before beginning my experiment I must mix the drug solutions to be used. First I will dissolve ibuprofen and caffeine tablets into a solution of water in two different containers, that I will later determine what strength to make each. I will also tear open cigarettes and mix the tobacco with water and let sit for 24 hours after which I will drain the water off into a container which will make up my nicotine solution. For alcohol, I will just mix vodka and water to the desired strength in a 4th container. Next, I will cipher out daphnia and drop it onto a slide to be viewed under a microscope. I will record its normal heart rate. Next, I will add a drop of the alcohol solution and over the next 5 minutes, I will record the changes in heart rate after one minute of exposure, 3 minutes of exposure and then 5 minutes of exposure. After recording my results I will dispose of this Daphnia. I will do this same portion of the experiment with two more daphnias. I will then continue with this procedure while using the other three drugs. I plan to use the lab facilities in the Biology Building on Tennessee Tech’s Campus. Along with most of their lab equipment including a microscope, slides, vials, Petri dishes, droppers, and other equipment. Materials Water Depression Slides

Cover slips

Droppers Daphnia Magna Microscope Watch Petri Dishes Daphnia Anatomy Chart Cigarettes 80 proof vodka No-dos Ibuprofen tablets Expected Results and Benefits After performing this experiment I expect to find that the Daphnia’s heart rates will increase with Nicotine and Caffeine because both of these drugs are stimulants and that the Daphnia’s heart rates will decrease with Alcohol and Ibuprofen solution. This experiment will show not only the effects of these drugs on Daphnia but also what they similarly do to the human body when it is exposed. Daphnia is used as a humane alternative to Humans when performing this type of experiment. Heart Rate of Daphnia when exposed to Caffeine and Alcohol Change in Heart Rate of Daphnia when exposed to Caffeine Change in Heart Rate of Daphnia when exposed to Alcohol Discussion After performing my experiment I found that Daphnia Magna heart rate greatly increases when exposed to Caffeine. Caffeine is a stimulant and should produce that effect. Caffeine has similar effects on humans.

The heart rate increased anywhere from 10 to 20 beats per minute. As seen in my data table the heartbeats sometimes jumped from a normal heartbeat in the 80s to a heartbeat in the 100s when exposed to caffeine. Gerald Adams also found the same result when he tested his hypothesis. I also found that Daphnia’s heart rate slightly increased with exposure to Alcohol. The heart rate does not have as drastic a change when exposed to Alcohol as it did when exposed to Caffeine. The heart rates just increased by about 5 to 10 beats per minute. As seen in my data table the heart beats only jumped from a normal heartbeat in the 80s to a heartbeat in the 90s when exposed to Alcohol. This was disproved by several different experiments. Wong found that the heart rate of daphnia decreased. Since alcohol is a depressant it should have lowered the heart rate of daphnia. I feel that the increase in stress on the Daphnia may have called this time of increase. When Daphnia is exposed to Nicotine and Ibuprofen, the heart rate of the daphnia could not be seen as any different. Although Cluevers said that there should be a change in the heart rate. Conclusion In conclusion I have determined that the heart rate of Daphnia can be affected by adding different drugs. Daphnia heart rate increased by ten to twenty beats per minute when exposed to Caffeine. Daphnia heart rate increased by five to ten beats per minute when exposed to Alcohol. Unfortunately, the results for Ibuprofen and Nicotine could not be seen. There was not enough evidence to determine how the Heart rate changed when the Daphnia were exposed to Ibuprofen and Nicotine. By doing this experiment it can be assumed that some of the same reactions could be found if Humans are exposed to these Drugs.

Reference

  1. Cleavers, Michael. 2004.
  2. Mixture toxicity of the anti-inflammatory drugs diclofenac, ibuprofen, naproxen, and acetylsalicylic acid. Ecotoxicology and Environmental Safety 59: 309-315. Foster, Rachel. 1997.
  3. A stroboscopic method to investigate the effect of caffeine on the Daphnia heart rate. Journal of Biological Education 31: 253-255. Nehlig, A., J. L. Daval, and G. Debry. 1992.
  4. Caffeine and the central nervous system: mechanisms of action, biochemical, metabolic, and psychostimulant effects. PubMed. com. Villegas-Navarro, Arturo, Esperanza L. Ross, and Jose L. Reyes. 2003.
  5. The heart of Daphnia Magna: effects of four cardioactive drugs. Comparative Biochemistry and Physiology Part C Toxicology and Pharmacology 136C: 127-134 Wong, Diana C. L., Philip B. Dorn, and Eric Y. Chai. 1997.
  6. Acute toxicity and structure-activity relationships of nine alcohol ethoxylate surfactants to fathead minnow and Daphnia Magna. Environmental Toxicology and Chemistry 16: 1970-1976.

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Questions on Psychology

1. Which of the following statements most accurately represents the use of plant-based psychoactive substances?

  • A. Plant-based psychoactive drugs are uncommon today and rarely used.
  • B. Today marijuana is the only plant-based psychoactive substance that is still used.
  • C. All plants that yield psychoactive substances are illegal today.
  • D. About 4,000 plants yield psychoactive substances, and the vast majority are not illegal.

2. The Gin Epidemic…

  • E. is a myth
  • F. was brought under control through high taxes and the strict regulation of the sale of gin
  • G. devastated the Middle East
  • H. is a current problem

3. The British encouraged the planting of hemp in the new American colonies for which of the following reasons?

  • I. to provide England with strong fibers from which it could make rope and sails for its ships
  • J. to produce psychoactive drugs derived from cannabis that could be sold to other countries
  • K. to ensure that the colonists would be high most of the time and therefore easier to control
  • L. as a means of payment to slave laborers

4. Listed below are three different sequential variations of drugs in the opiate family.

Which one accurately represents the order in which the drugs were discovered and used (from left to right, representing the oldest to newest drug forms).

  • M. opium, heroin, morphine
  • N. morphine, opium, hydromorphone
  • O. opium, morphine, heroin
  • P. hydromorphone, morphine, heroin 5. According to the authors of Uppers, Downers, All Arounders, a psychoactive drug is defined as…
  • Q. any substance that directly alters the normal functioning of the central nervous system
  • R. any substance that is illicit or illegal
  • S. those substance that causes numbness and drowsiness
  • T. hose substances that cause increased energy and alertness

6. The most rapid route of administering a drug to reach the brain is intravenous.

  • U. true
  • V. false

7. To titrate a drug means to continuously regulate the amount of drug you are receiving.

  • W. true
  • X. false

8. The physical, mental, and emotional effects a person experiences from taking psychoactive drugs are caused by the modification or mimicking of the neurotransmitters’ function.

  • Y. true
  • Z. false

9. A person’s level of emotional and physical stress can increase the ability of psychoactive drugs to cross the blood-brain barrier.

  • true
  • false

10. Active transport occurs when fat-soluble drugs pass from an area where there is a higher concentration of a drug to an area of lower concentration.

  • true
  • false

11. Passive transport occurs when water-soluble drugs such as cocaine cross the blood-brain barrier by hitching a ride on molecules that cross the blood-brain barrier.

  • true
  • false

12. Regardless of which method a person uses to consume a psychoactive drug, the drug reaches the brain through the bloodstream.

  • a. true
  • b. false

13. The more rapidly a psychoactive drug reaches its central nervous system target, the less the reward and the lower the reinforcing effect.

  • c. true
  • d. false

14. The central nervous system is composed of the spinal cord and the brain.

  • e. true
  • f. false

15. The compulsive gambler’s reward/control pathway in the brain becomes hijacked similar to the ways the brain becomes rewired from alcohol and other drug addiction.

  • g. true
  • h. false

16. On which part of the body does the long-term use of stimulants (e. g. , nicotine, cocaine, and methamphetamine) have the most significant impact?

  • i. skeletal system
  • j. muscular system
  • k. digestive system . cardiovascular system

17. The neurotransmitter most often involved in the use of strong stimulants is dopamine, which triggers feelings of…

  • m. hunger satisfaction/satiety
  • n. apathy
  • o. extreme thirst
  • p. emotional depression

18. Cocaine epidemics…

  • q. last for centuries
  • r. occur in cycles every few generations
  • s. are fictitious
  • t. have been exaggerated

19. Which form and method of using cocaine produce the most intense immediate high?

  • u. chewing pure coca leaves
  • v. snorting powdered cocaine
  • w. smoking crack cocaine
  • x. ingestion of cocaine in a beverage 20.

20. How long will the high from snorting a typical dose of powder cocaine (0. 2 to 0. 5 grams) generally last?

  • y. 1-minute
  • z. 5 to 20 minutes {. 40 to 60 minutes |. 2 to 3 hours

21. How long will the high from smoking a typical dose of crack cocaine (1 rock) generally last?

  • 1-minute ~.
  • 5 to 20 minutes
  • 40 to 60 minutes
  • 2 to 3 hours

22. How long will the high from a typical oral or snorted dose of amphetamine generally last?

  • 40 to 60 minutes
  • 1 to 2 hours
  • 2 to 3 hours
  • 4 to 6 hours

23. The illicit manufacture and distribution of methamphetamine in the United States today is due to the involvement of….

  • iker gangs like the Hell’s Angels
  • renegade pharmaceutical and industrial chemists.
  • Mexican gangs and drug cartels
  • Colombian cartels

24. Continued smoking to avoid the negative effects of nicotine withdrawal is known as…

  • inverse tolerance
  • negative drug reinforcement
  • positive drug reinforcement
  • reverse tolerance

25. Which of the following best describes how the first cigarette of the day affects a smoker?

  • increases blood pressure and heart rate
  • stimulates appetite
  • satisfies the nicotine craving for the rest of the day
  • all of the above

26. What is the half-life of caffeine?

  • a. 40 minutes
  • b. 1 to 2 hours
  • c. 3 to 7 hours
  • d. 24 to 48 hours

27. Among those who try a cigarette, what percentage will become daily habitual smokers?

  • a. 10%
  • b. 25%
  • c. 50%
  • d. 80%

28. Which of the following best describes one of the health benefits of quitting smoking?

  • a. The risk of heart attack is eliminated within a week of quitting.
  • b. Lung cancer rates to drop to the rate of nonsmokers after 40 years of nonsmoking.
  • c. Within just 20 minutes of quitting, blood pressure, pulse rate, and temperature of hands and feet drop to normal.
  • d. Within five days coughing, sinus congestion, and shortness of breath decrease.

29. Drinking alcohol before using cocaine will do which of the following?

  • 1. prolong and intensify cocaine’s effects
  • 2. cancel each other out because one is a stimulant and one is a depressant
  • 3. create cocaethylene, which increases violent tendencies
  • 4. create narcalon, which decreases the stimulant effects of cocaine.

results 2 and 4 only. results 1 and 3 only. results 1, 2, 3, and 4. none of the above

30. Prolonged use of strong stimulants (e. g. , cocaine, methamphetamine) results in which of the following?

  • 1. depletion of the body’s energy resources
  • 2. enhancement of the body’s energy resources
  • 3. cellular and organ damage
  • 4. paranoia.

results 1 and 4 only. results 2, 3, and 4 only. results 1, 3, and 4 only. results 2 and 3 only

31. The primary illegitimate source for obtaining prescription drugs, such as OxyContin, Vicodin, and Xanax, is over the Internet.

  • a. true
  • b. false

32. The number of people in the United States who overdose on heroin is greater than the number who overdose on any other type of opioid, including hydrocodone, oxycodone, and methadone.

  • a. true
  • b. false

33. Treatment for addiction to opiates requires physical detoxification and psychological correction.

  • a. true
  • b. false

34. Using a needle continuously to inject drugs in the same blood vessels can cause them to collapse.

  • a. true
  • b. false

35. An individual who is under the influence of heroin will have dilated pupils.

  • a. true
  • b. false

36. Depressants affect the central nervous system by elevating the user’s blood pressure, pulse, heart rate, and respiration.

  • a. true
  • b. false

37. Tolerance to one type of depressant, such as alcohol, can lead to the development of cross-tolerance for another depressant, such as benzodiazepines.

  • a. true
  • b. false

38. Human beings have naturally occurred (endogenous) opioids, which cause many of the same effects as those caused by taking opioid drugs (exogenous).

  • a. true
  • b. false

39. The majority of heroin available in the United States comes from Afghanistan.

  • a. true
  • b. false

40. Opiates block the release of substance P, which is the name of the neurotransmitter that transmits pain messages from nerve cell to nerve cell.

  • a. true
  • b. false

41. The “stop” switch in the brain, which tells your mind and body that it has had enough and disrupts the addictive cycle, is located in the brain stem.

  • a. true
  • b. false

42. Overdose deaths involving opioids most commonly include their combined use with other legal or licit substances like alcohol, benzodiazepines, or antidepressants.

  • a. true
  • b. false

43. One of the symptoms of chronic opiate use is itchy skin.

  • a. true
  • b. false

44. Law enforcement and treatment personnel can get a strong indication of what type of drug a person is using from the size of his pupils.

  • a. true
  • b. false

45. Opioids, such as hydrocodone (Vicodin), usually suppress nausea and vomiting.

  • a. true
  • b. false

46. Psychedelics come only from natural plant sources.

  • a. true
  • b. false

47. Synesthesia is defined as the crossing of senses, such as when visual input becomes sound.

  • a. true
  • b. false

48. The entire U. S. supply of LSD for one year weighs about 11 pounds.

  • a. true
  • b. false

49. In addition to their psychedelic effects, all-around also depress the central nervous system.

  • a. true
  • b. false

50. The strength of LSD/“acid” available on the streets today is stronger than the LSD/“acid” that was widely available on the streets in the 1960s and 1970s.

  • a. true
  • b. false

51. Tolerance to LSD develops quickly, within days of daily use.

  • a. true
  • b. false

52. Marijuana is not addictive and does not induce compulsive use.

  • a. true
  • b. false

53. Psilocybin mushrooms cause less disassociation, panic, and psychotic reactions compared with LSD.

  • a. true
  • b. false

54. People who take LSD may experience flashbacks (re-experiencing symptoms of a trip) that are similar to post-traumatic stress disorder.

  • a. true
  • b. false

55.  A “fry” is a marijuana joint dipped in formaldehyde or embalming fluid, dried, and then smoked.

  • a. true
  • b. false

56. Hashish is made from… pressed psilocybin mushrooms

  • a. cannabis resin
  • b. synthetic chemical
  • c. compounds
  • d. tobacco

57. Marijuana has been illegal in the United States since…

  • a. 1776
  • b. 1850
  • c. 1937
  • d. 1492

58. As of 2011 an ounce of marijuana in the United States costs…

  • a. $100 to $150
  • b. $200 to $400
  • c. $500 to $600
  • d. $800 to $1,000

59. Marijuana in the urine of a regular user is detectable for…

  • a. 1 to 2 days
  • b. 7 to 14 days
  • c. 3 to 6 weeks
  • d. 3 to 6 months

60. The hallucinating effects of Salvia Divinorum last for…

  • a. 30 minutes
  • b. 1 to 2 hours
  • c. 6 to 8 hours
  • d. 12 to 24 hours

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Banning Performance enhancing Drugs from Sports

At the onset, drugs are chemical substances that can affect the physical body. They are primarily made to treat illness and disease. However, there are some drugs that are used for other purpose beyond treating physical illness. These drugs are commonly known as the social drugs and are usually taken “to help people to or to give users an enjoyable experience” (Beashel, P. Sibson, A. & Taylor, J. p. 140).

While there are social drugs that are illegal, Beashe, Sibson, and Taylor (2001) aptly stated that many of these drugs are available within social institution and can be taken in the context of relaxing experience and enhancing sports performance (p. 140). There is nothing wrong with these so long as these drugs are publicly available which means their uses by the public are allowed by law. In other words, they are particularly not harmful to the physical body. Most of the performance enhancing drugs belongs to the so-called “social drugs.

” They are drugs that are available within social institution and are therefore not particularly harmful to the physical body, hence they should not ban from sports merely in the context of unfair competition since anyone can avail of those drugs within social institution. Currently, all performance enhancing drugs are banned in sports regardless of its positive physical effect. According to Beashel, Sibson, and Taylor, there are some performance enhancing drugs that are harmful but many are not.

Doping drugs like Nandrolone, testosterone, stanozolol, clenbuterol have the effect of reducing recovery time to be able to train harder and longer. These drugs also “increases muscle bulk, strength and endurance when combined regular exercise” (p. 141). These drugs are not harmful when taken correctly or responsibly, their impacts are obviously enhanced through regular exercise. Analgesics (narcotic) like Codeine, Methadone, and heroin are pain killers which their effect “allows training and competing even when injured” (p.

141). Other performance enhancing drugs such as Human growth hormone (HGH), erythropoietin are thought to improve performance, and increase number of red blood cells, which means that more oxygen can be carried to the muscles and endurance is improved. On the other hand, there are some drugs that need to be ban from sports. These drugs are those that are harmful to the physical health. Among these drugs are the Beta blockers. This drug according to Beashel, Sibson, and Taylor “keep heart rate and blood pressure low (p. 141).

While there are some benefit for low heart rate but this is only during the resting time not during the time of extreme activities. This is same with low blood pressure. Low blood pressure means that the does not pump enough which is important when doing extreme activities such as sports competition. Low heart rates may lead to dizziness and weakness in the flow of blood to the brain. Alcohol and tobacco drugs are no doubt harmful and should be banned as they also contribute to the reducing blood pressure and the heart rate. Banning only harmful drugs

Since performance enhancing drugs can be easily identified as harmful and not harmful, the government should ban only those that are harmful but allow with minimal restriction the use of non harmful drugs in sports. Responsible use of these drugs will not pose health problems rather it will enhance the potential of the athlete. Therefore what is needed is for the authorities to come up with better guidelines on the proper and responsible use of these drugs. Banning only harmful drugs will help athletes avoid using the wrong drugs that causes the health problems.

Thus, by categorizing harmful and non harmful, health authorities can easily provide necessary guidelines and information that will help the athlete avoid those harmful drugs, and they may be able to identify what type of drugs that they need. Banning all the performance enhancing drugs in sports is counter productive as it only leads to criminal offense due to substance abuse in the sense that it was use against the existing ban and not against the law concerning public health protection.

Allowing athletes to use performance drugs should they decide to do so Given the many hazardous and more dangerous substances that that are practically available to every body such as alcohol and tobacco which are among the top causes of deaths in America and in many parts of the world, it would be unjust to ban athletes from using performance enhancing drugs simply because of isolated case of death relating to the use of such drugs.

As it has been argued above, the lack of proper guidelines as to which drugs are harmful and which are not makes it more dangerous for those who really wanted to explore their potential rather than the drugs it self. Athletes who may wish to use such drugs should be given freedom to do so just as anyone who may wish to drink alcohol or they want to smoke they can simply buy tobacco practically anywhere. This is an inherent rights and the essence of the freedom of choice exercise freely by tobacco smokers or the alcoholics.

The arguments concerning natural and unnatural enhancement which emphasized that drug enhanced performance is illegitimate is not sound argument every athletes are taking all sorts of drug supplement such as vitamins, pills and so forth, just to keep themselves fit. The Database Book (2004) points out, “There is nothing “natural” about taking vitamin pills or wearing whole-body Lycra suits. The book noted that diet, medicine, technology, and even coaching already give an artificial advantage to those athletes who can afford the best of all these aids” (p.

88). By allowing athletes to use of performance drugs, it will provide equal playing field for everyone and athletes can compete openly and fairly. Allowing athletes to use performance enhancing drugs if the so wished enhanced the quality of sports and the entertainment it provides to the viewing public. Vincent Parrillo (2008) pointed that the most obvious reason why athletes wants to use performance enhancing drugs are “to become a better athlete and have enhanced sports related outcomes” (p. 263).

Parrillo further add that athletes use such substance “to recover from and prevent injuries, to improve their appearance, and in some cases in response to pressure from coaches” (p. 263). These reasons are not at all subjective and they are valid. Regardless of what others say, athletes are being pressured to do more than they can do with their natural capacity by their coaches to win their games. The argument that allowing athletes to use performance enhancement drugs is like sacrificing the health of the athletes for the sake of better entertainment does not really hold much.

With proper information and guidelines on the use of such chemical substances, there is no way that the athlete’s health could be sacrificed. It could not be denied that the public enjoys watching high level competition. The public are the tax payers where the money for sports development is coming from and they deserve high level sports. The incidents of deaths among athletes who used performance enhancement drugs can still be considered isolated compared to the deaths caused by alcohol and tobacco.

If there is any thing that should be banned in sports it is certainly not those harmful drugs, but first and foremost are tobacco and alcohol and those drugs that are proven harmful to the health not only of the athletes but of everybody. The use of performance enhancing drugs among athletes continued to scandalize different sports competition spawning splinter group of competitors and sports administrators to promote the concept of officially legalizing the use of some of the substances that enhanced performance.

Legalizing drugs will not only eliminate the problems of unfair competition but also the shame and embarrassment of athletes who may have use the substance not for winning a particular game but for fast recovery from injury to be able to play the next game. Allowing the use of performance enhancing drugs for athletes is very practical and a solution to the conflicting view of what is drugs and what is not. Nigel South (1998) noted that even tea and Coffee “have both been illegal drugs and vilified, as is alcohol today in Saudi Arabia and a number of other Muslim countries” (p.

104) while cannabis and other stimulant drugs “have been and continue to be not only legal in some parts of the world but also an important aspect of their culture in which they are used” (South, p. 104). Conclusion While most of the authors and important personalities in sports are against the use of drugs in sports, they cannot deny that no matter were the efforts to make sports drug free, it remains the source of scandal and embarrassment not only for the athletes, but also for the nation they represents.

Just like the problems of illegal drugs on the street that have never been beaten despite on the war on drugs, the use of performance enhancing drugs will persist so long as the athletes are being pressured to do beyond their capacity in order to win the game. Because of the nature of some drugs and its medical prescription on patient, there will always be an effort to exploit the situation to gain an advantage in sports.

Only when athletes are allowed to use such substances should they decide to use them can the fair playing field will be realized. Thus, Athletes should be allowed to use such substances in the name of fairness and high level competitive sports. Reference Beashe, P. Sibson, A. & Taylor, J. (2001) The World of Sport Examined China: Nelson Thornes The Debatabase Book (2004) USA: IDEA Parrillo, V. (2008) Encyclopedia of Social Problems USA: Sage Publication South, N. (1998) Drugs USA: Sage Publication.

Writing Quality

Grammar mistakes

F (48%)

Synonyms

A (93%)

Redundant words

F (48%)

Originality

100%

Readability

F (47%)

Total mark

D

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Bristol Myers Squibb

Bristol Myers Squibb was formed in 1887 when McLaren Bristol and John Ripley Myers bought the Clinton pharmaceutical Company in Clinton New York. In 1900 Bristol-Myers broke through into the black — it has remained there ever since. In 1924, gross profits topped $1 million for the first time in Bristol-Myers’ history. The company’s products were then sold in 26 countries. At this point, the shares held by John Myers’s heirs became available for sale, triggering a series of moves that in 1929 turned Bristol-Myers into a publicly held company, listed on the New York Stock Exchange.

The postwar depression prompted Bristol-Myers to jettison its pharmaceutical business and devote itself entirely to its specialties: Sal Hepatica and Ipana, its two big winners, and a dozen or so assorted toiletries, antiseptics and cough syrups. By the end of the war, it was clear that penicillin and other antibiotics represented an immense opportunity for Bristol-Myers. In 1921 the Squibb Company coined its slogan: “The priceless ingredient in every product is the honor and integrity of its maker”, which is now the corporate slogan of Bristol Myers Squibb.

In 1989 Bristol-Myers merged with Squibb, creating a global leader in the health care industry. The merger created what was then the world’s second-largest pharmaceutical enterprise. BMS is now ranked #8 in the pharma sector. Current Drugs, Issues and Interests The Company operates in three segments: Pharmaceuticals, Nutritionals and Other Healthcare. The Pharmaceuticals segment is made up of the global pharmaceutical and international consumer medicines business. The Nutritionals segment consists of Mead Johnson Nutritionals (Mead Johnson), primarily an infant formula and children’s nutritional business.

The Other Healthcare segment consists of ConvaTec, Medical Imaging and Consumer Medicines (United States and Canada) businesses. In 1991, the company received U. S. Food and Drug Administration (FDA) approval in the U. S. for Videx® (didanosine) also known as ddI, making it the second medicine available for treating HIV infection (the other being AZT). Other approvals that year included an antibiotic, Cefzil® (cefprozil); two cardiovascular agents, Pravachol® (pravastatin sodium) Tablets and Monopril® (fosinopril sodium) Tablets; and a central nervous system drug, Stadol NS® (butorphanol tartrate) C-IV.

In that same year, the companies signed a Cooperative Research and Development Agreement with the National Cancer Institute to research and develop a new compound for treating certain types of cancer. This compound, TAXOL® (paclitaxel) Injection, immediately was established as the company’s top research priority. Bristol-Myers Squibb invested hundreds of millions of dollars to supply TAXOL in sufficient quantities for clinical trials, to prepare data for regulatory submission and to develop alternative sources of TAXOL (which originally was derived from the bark of an endangered tree, the Pacific Yew).

TAXOL launched in 1993 and quickly became one of the world’s most widely used cancer treatments. For a few years BMS held the exclusive rights to harvest the bark of the endangered yew trees on US soil, the tree’s bark is used in making TAXOL. By the end of 1995, the company had over 60 product lines with $50 million or more in annual sales worldwide. At the beginning of 1998, the FDA granted clearance to market Excedrin® Migraine for the relief of migraine headache pain and associated symptoms. Excedrin Migraine became the first migraine headache medication available to consumers without a prescription.

In 1999, Bristol-Myers Squibb announced SECURE THE FUTURE™, a $100 million commitment to advance HIV/AIDS research and community outreach programs in five southern African countries: South Africa, Botswana, Namibia, Lesotho and Swaziland. And in 2000, Bristol-Myers Squibb, together with four other pharmaceutical companies and international agencies, joined the UNAIDS Drug ACCESS Initiative. The ACCESS program aims to make antiretroviral medicines and therapies to treat opportunistic infections more widely available in African countries that have developed a coherent national AIDS strategy.

As part of the program, the company offered to lower the prices of HIV/AIDS medicines in those countries by 90 percent. More recently, Bristol-Myers Squibb took its access efforts a step further, offering HIV/AIDS drugs below cost in Africa and committing an additional $15 million for extending SECURE THE FUTURE to four Western African countries — Burkina Faso, Cote d’Ivoire, Mali and Senegal. The company is also ensuring that its patents do not prevent inexpensive HIV/AIDS therapy in Africa.

The patent for Zerit, rights to which are owned by Yale University and Bristol-Myers Squibb, is now available at no cost to treat AIDS in southern Africa. However, issues like losing patents like this and a few more in South Africa has caused many problems for drug companies and BMS is not immune to them. In September 2000, Bristol-Myers Squibb announced a new strategy that includes a sharpened focus on medicines and an aggressive external development program. As part of this new strategy, the company announced its intention to divest its Clairol and Zimmer businesses.

The company announced in June 2001 that it had entered into a definitive agreement to acquire the DuPont Pharmaceuticals Company for $7. 8 billion; an acquisition intended to further strengthen Bristol-Myers Squibb’s medicines business. With the DuPont acquisition, Bristol-Myers Squibb added Sustiva® (efavirenz) Capsules to its HIV portfolio and also gained products such as Coumadin® (warfarin sodium tablets, USP) Crystalline, the U. S. leading prescribed anti-coagulant and Cardiolite® (Kit for the preparation of Technetium Tc99m Sestamibi for Injection), a medical imaging agent.

In November 2002, the FDA approved Abilify® (aripiprazole) for the treatment of schizophrenia. In 2003, the company teamed up with cancer survivor and Tour de France champion Lance Armstrong to sponsor the Bristol-Myers Squibb TOUR OF HOPE™, an unprecedented week-long coast-to-coast cycling event. En route, the 26-member team of cancer survivors, caregivers, physicians, nurses and researchers raised awareness of cancer research and the importance of clinical trials in developing new treatments.

Reyataz® (atazanavir sulfate), the first protease inhibitor for the treatment of HIV/AIDS with once-a-day dosing, was introduced in the U. S. in July 2003 and approved for marketing in Europe in March 2004. On March 29, 2005, the FDA approved Baraclude® (entecavir). Baraclude, discovered by Bristol-Myers Squibb scientists, is indicated for the treatment of chronic hepatitis B infection. Bristol-Myers Squibb announced the FDA approval of Orencia® (abatacept) for the treatment of rheumatoid arthritis on December 23, 2005. Orencia is the first in a new class of medications for this disease.

On February 28, 2006, Bristol-Myers Squibb and Somerset Pharmaceuticals announced FDA approval of EMSAM® (selegiline trasdermal system), the first transdermal patch for the treatment of major depressive disorder. SPRYCEL® (dasatinib), discovered by Bristol-Myers Squibb scientists, was approved by the FDA on June 28, 2006, for the treatment of chronic myeloid leukemia. Bristol-Myers Squibb and Gilead Sciences announced the FDA approval of ATRIPLA™ (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) on July 12, 2006. ATRIPLA is the first-ever once-daily single tablet regimen for HIV.

As a strategy they are focusing on ten diseases, these are affective (psychiatric) disorders, Alzheimer’s/dementia, atherosclerosis/thrombosis, diabetes, hepatitis, HIV/AIDS, obesity, oncology, rheumatoid arthritis and related diseases, and solid organ transplant. Current Financials The current financial information of the company from MSN Central is as below. The revenues have not been growing in spite of all the successful products that have been launched and that is an area for change. The company needs to improve its revenues and have a positive trend in profits too.

The profits are almost 16%, however, that looks pale when compared to GSK and Merck – both in the 20- 22% range (Fortune 500 list). In fact at 15%, the company is ranked 10 out of 12 in the pharma sector and the revenues are 8 out of 12. That for a company that is going to be 120 years in 2007 is poor. As discussed in the current drugs, issues and interests section, the company is focusing on some key diseases and getting some fantastic drugs in the market. However, all this is somehow not improving the revenue. In fact in the last 5 years, revenue has grown at less than 2% year on year.

On the current price ($24), the share gives a 6% return on investment (EPS is $1. 43). Currently, they are benefiting from the effects of letting go of their CEO Peter Dolan and the company is touted as a takeover target. Their major problem is the failure to prevent Apotex from manufacturing Plavix. Although BMS tried to stop Apotex by getting into a deal that would give Apotex $40 million for not manufacturing the drug, the US State Attorney Generals however didn’t let the deal go through and instead the company got into an investigation because of the whole mess that the deal created.

From the BMS perspective, they were doing the right thing; Plavix generates revenues of $5. 9 Billion. $3. 8 Billion are BMS and the rest is Sanofi-Aventis. $3. 8Billion is almost 20% of BMS’s revenue and Plavix gives approximately 40% of the profits in their US business. All this has a big impact on the dividend given by the company and most analysts have suggested that the dividend payout will have to be cut by almost 30-40 cents; it was $1. 12 the previous year.

BMS has a good line up of drugs that are in the pipeline and would be a good takeover for any pharma company that has strong cash flow but weak pipeline. These are rumors but looking at the current scenario, it is a good possibility. The interim CEO James Cornelius headed Guidant and helped its sell-off. Vision, Mission and Goals The current vision mission and goals of BMS are referred as a pledge. The pledges are to different stakeholders and are as follows: The BMS Pledge Our company’s mission is to extend and enhance human life by providing the highest-quality pharmaceutical and related health care products.

We pledge — to our patients and customers, to our employees and partners, to our shareholders and neighbors, and to the world we serve — to act on our belief that the priceless ingredient of every product is the honor and integrity of its maker. To Customers We pledge excellence in everything we make and market, providing the safest, most effective and highest-quality medicines and health care products. We promise to continually improve our products through innovation, diligent research and development, and an unyielding commitment to be the very best. To Shareholders

We pledge our dedication to responsibly increasing the shareholder value of your company based upon continued growth, strong finances, productive collaborations and innovation in research and development. To Communities We pledge conscientious citizenship, a helping hand for worthwhile causes and constructive action that supports a clean and healthy environment. We pledge Bristol-Myers Squibb to the highest standard of moral and ethical behavior and to policies and practices that fully embody the responsibility, integrity and decency required of free enterprise if it is to merit and maintain the confidence of our society.

The new era for BMS must ensure that the pledge to the shareholders is held more firmly than it has been in the last few years. The company must improve revenues and margins. The stagnant revenues and profits are a cause for worry in the longer run. All pharma companies are fighting against smaller companies that want to make generics and Pfizer itself has been fighting for the patent of Lipitor, the world’s best selling drug with $12. 9 Billion in revenues. BMS needs to ensure that the scandals that have been hitting it in the last 5 years never happen again and the company needs to have a higher standard of governance.

Shareholder value erodes very quickly for many reasons, but off the last 3-5 years, corporate governance has been a major issue. Companies with tens of billions of dollars of revenue have disappeared and stockholders have suddenly seen their investment disappear with them. BMS has serious corporate governance issues. The company was hit by financial scandals when it was caught pushing inventories and showing them as sales. They have a court appointed overseer because of showing higher revenues and now with the Plavix issue they are in an even bigger mess as far as corporate governance goes.

Apart from that, according to IMS health, a pharmaceutical information and consulting company, sales of prescription medicines worldwide rose 7% to $602 billion,. The United States still accounts for the lion’s share of that, with $252 billion in annual sales, but sales in it and the other nine biggest markets grew by only 5. 7%. But emerging markets such as China, Russia, South Korea and Mexico outpaced those markets, growing a whopping 81%. However, when we look at the overall picture 10 -20 years from now we see that the population of the developed world is going to fall and there will be more and more people who will be retired.

This also means there will be more medicines required. I do not see myself dying at the age of 70 in the year 2040; medical technology will be so advanced in the next 30 years that it will probably keep me alive till I reach 80 or 90. This is great news for the pharma companies. However, the question beckons that the people who can afford expensive medicines for diseases that BMS is targeting are only in the developed countries where the growth has stagnated or is less than 10%. The growth is in the developing world, but the diseases that BMS is targeting are all that need lots of medicines and very expensive medicines.

Taxol for example, is used for cancer patients. The medicine is now made by other companies too, and yet the prices for Taxol in the developing world are really high and people find it hard to afford Taxol. In my opinion, BMS has to handle 2 issues: First is Corporate Governance and the second is to crack the developing markets and increase market share in those countries, this will automatically increase its stagnant revenues and breathe some life into its ailing business. The markets are stagnant in the developed world.

New Vision Statement I am making a few changes to the current pledges that BMS has to customers and shareholders. The changes reflect what the company needs to do in order to transform itself. To Customers We pledge excellence in everything we make and market, providing the safest, most effective, and cost effective and highest-quality medicines and health care products. We promise to continually improve our products through innovation, diligent research and development, and an unyielding commitment to be the very best. To Shareholders

We pledge our dedication to responsibly increasing the shareholder value of your company based upon continued growth, strong finances, productive collaborations and innovation in research and development. We pledge to be extremely careful in all governance issues and not succumb to the pressures of the market. We pledge to conduct our business with utmost fairness. Key Change Issues Lack of Corporate Governance is something that no company will admit, but that is the major problem facing BMS right now. Having an overseer is a bad indicator. The key change issues that we will face while changing the attitude towards corporate governance are:

1. The first issue is to change the behavior of bosses who force employees to act in ways that will be against any corporate governance policy. 2. The second change will be to create an atmosphere where an employee can raise an integrity or corporate governance concern. This is critical right now as it seems that over the last few years many things were not raised. 3. The third change will be in terms of managing the markets and expectations of all stakeholders, ultimately it is the expectations of the markets or other stakeholders that push the employees to cover up things or show a bright picture when there is none.

It is important to manage the expectations. The next key change after corporate governance is to ensure that we can capture the growing markets. To capture the new markets, we will have to make a couple of changes in the way we do business. These changes are likely to be as follows: 1. Lower the cost of drugs – most of the money goes into research. The drugs that conquer markets cost hundreds of millions of dollars to make. So the cost of developing drugs has to be lowered, once this cost is lowered, the cost of the drug per se can also be lowered accordingly.

2. Come with products that cater to the growing segments there – it is likely that the people in the developing countries will be using medicines that are generic. For a branded product to conquer that market, the companies have to give an added value to their product. This might mean, reworking some of the old compounds and coming up with ‘extra strong versions’ or other versions that would differentiate the medicines BMS could come up with a line of medication aimed at women with PMS or aimed at people over 70.

This might be the normal medicines, but with a different potency or properties so that they would be ‘better suited’ to a different age group. 3. Newer gene types – this might mean that there will be opportunities as people from different races might have different problems or might need different treatments. It is possible that the genes or body types in different races might respond differently to different molecules and thus would require modifications to the current molecules. Depending on the cost of doing this modification, BMS can decide to modify certain molecules to better suit different races.

How will these areas be changed? What are the broad sets of proposals for change? The Critical Change requirement is Corporate Governance. Corporate Governance is something that every company talks and boasts about but as we can see in case of BMS, this has failed grossly. The company actively needs to change the situation within its departments and especially in the higher ranks to improve the Corporate Governance scenario and educate people about the problems that are caused because of bad governance.

Before I dwell into how to combat corporate governance, I would like to talk about why officials higher up in the ranks and even some in the lower ranks resort to concealing information that might be damaging to the company. The first reason is to ensure that their jobs are secure. If a person conceals information it is because they feel that the particular piece of information will be damaging to their job, their department or their interest. This is the basic level and it is very individualistic. However, it is this same thing that drives even the bigger corporate information scandals.

The second reason for concealing information or reporting wrong figures is to ensure that the company meets its goals. To take an example from an IT company, it is one thing to not report a data theft because it might compromise the jobs of the IT security personnel, but quite another not to report the bugs that might exist in the new software that a company is making. Different projects have different timelines and it is critical for companies to meet those timelines as revenues and profits are based on the sales of that new product.

If we take windows Vista for example, vista has been delayed numerous times and because of that many partners of Microsoft are suffering, especially Intel. Microsoft has in public announced about the delays; however a smaller company might choose to not mention a delay in their quarterly update. For the officials in the company it is something that protects the shareholders and other partners from the value perspective, but what they fail to see is the long term damage that their actions are causing.

Concealing information today will have its repercussions in the next two quarters and eventually if someone finds out the true picture, the stock market will kill the script and the valuation will suffer enormously. However, a public announcement about the delay will cause temporary drop in the stock valuation (till the product is back on track or launched in the market) but on a personal level, it will affect the persons’ bonus (for sure) and the growth prospects of the higher ranks who were responsible for not delivering the results.

The cost of revealing the truth means jobs and immediate losses in the stock markets. Many of the higher ranking officials have stock options and this makes it even more lucrative from a personal perspective to ensure that the company is shown in good light and seen as an entity that meets its goals and beats the market predictions. The corporate governance scenario gets worse because of the stock options but it can be much better if every one looked at the picture from a long term perspective. In the longer term, the company will deliver the products and make the profits.

What every individual must realize is that a company will survive beyond every employee and every leader. One employee or a leader cannot make the company, there is always a team. However, a leader can easily break the company and corporate governance is one way of doing it with much ease. Coming to ways on how BMS can change the corporate governance culture within the organization; I would recommend the following 3 changes: 1. Top down pressure to conceal information 2. Protective climate for whistle blowers 3. Managing the expectations of the stock market and other stakeholders

Top down pressure to conceal information Driving the first one seems to be the toughest one, but this is where the board members have to set the rules and deal facts with an iron hand. All directors and Country Heads must be responsible towards Corporate Governance and the Finance people especially should run their reports through the board. The board must appoint an independent third party evaluator and auditor to ensure that the reports being presented are correct and any discrepancy must be dealt by terminating the country head and seizing all stock options that the person may have.

Termination with seizure of stock options at all levels will mean that the lure of a high stock price will not be a motivating factor in concealing information and we can expect people to take a long term view of the situation instead of a short term view based on when their stock options might be due. With a personal lure of money gone, the top management would be forced to look at share value in the longer term and hence won’t be pushing their direct reports to fudge information.

In addition to this, I recommend that one board member be assigned the task of being an auditor and also the point of contact for all kind of tip-offs or corporate governance whistle blowers. This will give the employees all over the company more faith in the system. The biggest problem for whistle blowers or people who have issues with corporate governance is that they fear for their jobs and they fear that if they still have their jobs, they will be treated will disgust in the office for going against what might be termed as ‘normal practice’ in that division.

The presence of a board member as a person who can look into corporate governance issues ensures that people can raise concerns in confidence without the fear or being outcastes at their jobs. This board member of course needs to have a team of people who will investigate the issues that are raised. At the middle management level or at the level where people head departments at country levels, the country head must tighten the leash and implement all corporate policies.

The country heads must have audits from outside parties to ensure the authenticity of the financial statements and the systems within the company. At the lower management levels the managers should be responsible for their business. However; the ultimate responsibility would be with the middle management. The board member however, should be contactable by everyone within the organization. The organization change needed is to re-align the salary packages of the people who have stock options.

This would entail the compensation and benefits team to look at the packages again and set up a new corporate policy about rewarding and retaining employees. The major change is only for the upper management to ensure that they don’t abuse their power to increase the value of their shares. The stock option change will also weed out the people who do not have a longing for working with BMS. It is very important for a company to ensure that their top management is a group of people who take the company close to their heart, and of course these people are there for the long term.

Protective climate for whistle blowers The next issue we need to cover is about protecting the whistle blowers. The appointment of a board member to look after the corporate governance issues should quell any fears that a person might have about corporate governance. In addition to this, a very small step that might go a long way is to bring up issues with a pseudo identity, where people can write in and give information without being obligated to divulge their identity even to the board member.

The whistle blowers biggest fear is that their job and career gets jeopardized if it is found out that they were the ones who raised concerns that brought down the whole unit and the jobs of several people. People take it against them and they are outcaste. I also recommend that these people have help from outside sources such as counseling etc that may be needed as they grapple with the effects of being whistle blowers or as they continue to live without talking to anyone about being the whistle blowers.

In addition to this, the company should actually owe these people an incentive for doing the company a favor by helping it exposing thing internally and managing the fall out and taking corrective actions. Such revelations by outsiders can be far more damaging and bring the company into disrepute apart from all the lawsuits and the hassles of the law. The board is always responsible for ensuring that things are going on smoothly within the company and ultimate beneficiary of having an internal system that exposes the corporate governance problems within the company actually helps the board save the company and their own reputations.

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Moving from prescribing medications by brand name to INN

Table of contents

Abstract

Drug prescription is not only a routine in medical use functioning, but also plays pivotal role in improving the health status of patients seeking such services. The nature and efficacy of pharmacy services depends on the extent of professionalism, which define the methods and ethical standards with which one carries out such duties.Furthermore, pharmaceutical services vary from one place to another, and often governed by the prevailing state laws. This research paper therefore, presents a detailed discussion of two main aspect of pharmacy. The first section entails the shift in the drug prescription methods, from the initial brand based method to the modern based on the active ingredient making up the medicine. The second section outlines the contribution of a pharmacist in influencing the brand of medicine that can be prescribed in a clinical process.

Introduction

The efforts aimed at changing the health care provider’s prescribing behaviour to achieve consistency with the ever changing best medical practises is the chief challenge ensuring the safest dispensation and use of medicine. Due the emergence of new data about the use of drugs such as their effectiveness, dosing options, side effects, indications as well as contraindications, the existing pharmaceutical options also keep on evolving (Garcia-Gollarte et.al, 2012). As a result of the new changes in the medical practises, there are resulting gaps between the prescription options based on evidence, and the usual practises in most clinics. For example, other than the common error of under dozing and over dozing, the prescribers may occasionally give particular medicines for wrong conditions.

Biological Medicines and Biosimillar medicines

The biological medicines are also referred to as biologics, and consist of organic compounds made through biotechnological mechanisms. The biologics appeared for use in the 1980s, and have since then advanced to bring improvements in the treatment of many diseases. Their uses as alternative medicine have revolutionized the treatment of diseases, which has led to the improvement of health status across billions of people in the world. Consequently, this category of drugs has become popular since their introduction, a process whose end has seen the diminishing power of the original biological medicine. There are many manufacturing companies, who have acquired the permission to manufacture similar brands of the original biological medicine, commonly trending the medical market as biosimillar medicines.

As a result of the existing complexity in the process of manufacturing the original medicine, the biosimillar medicines do not qualify for the generic class of medicine (Dylst, Vulto & Simoens, 2013). This is mainly due to the fact that this category is not typically identical to the original medicine. There are concerns regarding the authenticity and the effectiveness of the process of differentiating between such biosimillar medicines and the original biological medicines. These concerns are based on the extents of similarities observed when such drugs are used, as compared to the original biological medicines.

For example, under same conditions of a particular patient, when a biosimillar is compared with Infliximab, the uses of biosimilars have manifested the same therapeutic efficacy, as well as the incidences of drug related events. In addition to the similar levels of therapeutic efficacy, biosimilars are equally tolerated by the body system, and also comparable in terms of their safety issues. It is the complexity in their manufacturing processes, in tandem with safety concerns that the ongoing monitoring derives its basis (Declerck & Simoens, 2012).

Concerns regarding the use of biosimilar drugs

The concerns rose over the issues relating to safety, efficacy and the cost of using the biosimilars have resulted into the urgent need for a change of prescription method from the initial brand name to the use of active ingredients. This is because of the compromise of such brands, in which certain biosimilars do not recognize the copied brands, and thus creating confusion.

The key concern that has been raised through the Pharmacovigilance involves the criteria wit which one can use to draw a line between the original biological medicine and the biosimilar medicines. There are a plethora of biosimilar medicines that after manufacturing have been approved by the European Medicines Agency. Such approvals have derived their bases on the abbreviated programs, in which the manufacturing process was purely based on copying the formula of those biological medicines already in the market. Some of these biosimilar medicines in this category exist in the market, despite lack of approval by the regulatory bodies, under the legal regulatory frameworks within Europe. Their lack of approval has therefore led to the ultimate doubt about the validity of such medicines, especially the possibility of adverse reactions occurring as side effects.

The cost of purchasing the biosimilar medicines has also raised major concerns in the pharmaceutical industries in the Europe, just like other parts of the world. The relative low cost of acquiring such medicines has led into a perception by many people, that the existence of cheaper alternatives could be derailing the development of the industry. Consequently, there is an increase of pressure to prescribe the cheaper and new alternatives among patients, who may not afford the original biological medicines. Furthermore, such pressures have led to the increased use of such alternatives without any critical attention paid to the criteria of prescription and application of brand names.

Transition from the drug brand name to the INN system of drug prescription

The recent decades have been epitomised by a major burden of chronic diseases, not only among the European member states, but also across the globe. In order to curb the ever growing menace of such diseases among populations, the concerned authorities such as the World Health Organization, through respective governments have had to act. The chief aim of such action by the WHO, through respective governments have been to facilitate, and enforce laws to ensure that all professional health workers and patients access the safest, high quality, modern and affordable medicine to improve the health status of their people. Biomedical studies over time have identified the biological medicines as one of the most effective categories of medicine that can meet this criterion.

However, the main challenge in the provision of such biological medicine has been manifested on the means of identification by both patients and pharmacists during prescription. Surveys have further pointed out that the method of prescription plays a pivotal role in limiting the resulting confusion during the identification of drugs from place, particularly from one country to another within Europe (CDC, 2012). For instance, over the recent decades, the method of prescription has been based on the brand name. There are a number of factors that determine the brand name for a particular medicine, such as the location or trans-border movements within Europe.

Such variation have therefore been a core ingredient in breeding the much confusion when prescribing drugs from one place, especially for patients who may be new in such places. A particular brand name for a medicine used at one point may either be unfamiliar, or used for a different medicine in another place (Rotenstein et.al, 2013). Consequently, the need for a more standardised system of naming and prescribing drugs across the globe, including the European member states becomes an indispensible discourse. The European member states, in tandem with the world, have therefore joined the movement from prescribing medications by brand name to the INN International Nonproprietary Name (INN). Currently, there is a legislation process, whose purpose is to prevent doctors from brand prescription, but rather an active ingredient in the medicine, to allow easy determination by the patient.

The International Nonproprietary Name (INN)

The International Nonproprietary Name is a special term in healthy sciences and medicines, which is given to pharmaceuticals for purposes of easy identification. Having been initiated by the World Health Organization, the INN system of identification began to operate in 1953, for the benefit of not only the health workers such as pharmacists, but also help patients identify their medication with ease. The ease of identification was based on the common aim of the system for the generation of convenient common names for the existing pharmaceutical substances. In this case, each name generated under this system becomes unique for a global recognition of the substance as a public property. Consequently, the INN given to each pharmaceutical can have wide uses for the manufacturers and users, as well as the process of generic prescription in studies regarding drug use (CDC, 2012).

The use of the International Nonproprietary Name in the drug prescription process functions to harmonise the communication regarding the medical activities among health professionals, drug consumers and patients. As a result, this system helps to prevent potential occurrence of medication errors. A medication error refers to any resulting misconception in the processes of drug prescription, dispensation, administration as well as monitoring the use of a particular drug. Medication errors are a major cause of most adverse reactions in patients, whose prevention can easily be achieved through accurate use of the relevant drugs.

The accuracy can also be achieved through a process of synchronization, in which a single drug can retain a single identification from one place to another. A prescription method, based on the active ingredient as the common component of a particular drug, such as the INN system, has been enforced through a new legislative body referred to as the European Union Pharmacovigilance Legislation. Pharmacovigilance is a process, which consists of scientific activities of detecting, conducting an assessment of the adverse risks, understanding, and the establishment of potential prevention measures for the resulting adverse reactions (CDC, 2012).

The European Medicines Agency

Responsibilities

The chief responsibility of the European Medicines Agency is to obtain and report the relevant data regarding adverse drug reactions, resulting from medical errors. Such reports are gathered and submitted to the Eudravigilance, a database that stores all the relevant data for medical errors among the European member states. Moreover, the database system is designed in such a way that it does not only receive the relevant information on adverse drug reaction, but also processes, stores and avails upon demand, the stored information after electronic submission.s

The database run by the European Medical agency also permits users to conduct a critical analysis of the data herein, and enables one t make accurate conclusions regarding the data collected in determining the prevailing medical trends in different regions of Europe (Declerck, & Simoens, 2012). In the modern system, there are legislative measures, which ensure that the data regarding medicines are stored and undergo general processing, during which drugs should maintain a standard description using the active ingredient, other than the initial brand name.

In addition to the data reception, storage, and analysis through the Eudravigilance database, the legislative body also has a role of coordination among the European member states. The coordination role between different medicine regulatory authorities across Europe also involves all the individual Pharmacovigilance centres, as well as the patient safety authorities. The main aim of this role is to ensure that there is mutual flow of relevant information among the member states, so as to enhance communication of the occurrence of adverse drug reactions.

The Pharmacovigilance Risk Assessment Committee (PRAC) is also a legislative committee charged with a duty of offering the requisite recommendations for all medicine regulatory frameworks within the EU (Allen & Ansel, 2013). The recommendations made by the Pharmacovigilance Risk Assessment Committee function to enhance further safety issues, resulting from inappropriate use of medicines in various regions across the member states
(O’Connor, Gallagher & O’Mahony, 2012). While formulating these recommendations, the committee takes into considerations, including risk management issues, to monitor the extent of effectiveness, with which various mechanisms help to eradicate the occurrence of medication errors and adverse drug reactions.

Role of a Pharmacist in Determining a Drug Prescription

Pharmacists have the most critical role in determining the type or brand of medication to prescribe. This is because they are the base of the powers for dispensing the drugs for patients, in a normal clinical routine (Gibberson et.al, 2013). When lack of professionalism occurs in the dispensation of medicines for patients, there are higher chances of adverse medical reactions resulting from medical errors. Each year, the occurrence of medical errors, emanating from inappropriate prescription and dispensation of medicines by unprofessional pharmacists has caused harm to at least 1.5 million people. Furthermore, the loss incurred in terms of the cost of treating the injuries caused in hospitals runs at higher levels of at least $3.5 Billion each year. However, these cost estimates do not take into account the additional cost in terms of the extra wages and salaries incurred while causing and correcting such messes (Spinewine, Fialova & Byrne, 2012).

Throughout history, pharmacists have played a pivotal role in ensuring an improved patient health through appropriate prescription and dispensing of the right brand of medicine. Through improved disease management techniques and therapy practises, effective spending in healthcare activities, and enhanced adherence leads to improved quality of life (Haga et.al, 2013). In order to influence the brand of medicine to prescribe for a particular patient, the pharmacist should acquire a deeper comprehension of the patients’ medical condition. Most often, the pharmacist relies entirely on the information obtained from the technician, which helps them provide additional base for the patient’s safety (O’Connor, Gallagher & O’Mahony, 2012).

In order to obtain the required accuracy, it is important for the technician to observe strict adherence to the system based procedures when obtaining the information regarding a patient’s medical condition. In cases where the technician experiences unusual or any form of abnormalities, it is their responsibility to inform the pharmacist, to enable them prescribe and dispense the right brand of medicine (Allen & Ansel, 2013).

The Scope of Practise in Pharmacy

The scope of practise for different pharmacists varies from one country to another, depending on the prevailing state laws. The governing board of pharmacy also plays a pivotal role in determining the extent to which professional pharmacists can exercise their powers, and ability to influence the type of prescription. There are sets of regulation in various countries, which permit the pharmacists to exercise their powers as professional within specific areas within the medical care system (Law et.al, 2012).

On the other hand, other countries have laws that encourage a broader approach to service delivery within the medical service delivery. The pharmacist may therefore take part in different parts of the medication, ranging from diagnosis, prescription, drug dispensation as well as monitoring. The pharmacist therefore has a wide range of options and opportunities, during which they can influence the prescription of a given medicine (Abood, 2012).

Job Satisfaction

Job satisfaction is another aspect of enabler, through which pharmacists acquire an opportunity to influence the prescription. In the modern world of health care system, the practise of pharmacy has advanced from the initial practise of dispensing medicine and offering counselling sessions to offering more detailed clinical patient care services. In cases where a pharmacist meets restraining conditions in which they are unable to offer a wider spectrum of services to their patients, they often lack satisfaction from their jobs (Allen & Ansel, 2013).

Eradication of fraudulent prescription

The main source of medical errors often emanate from fraudulent prescriptions, some of which are out of human intervention, while the rest may be unintentional. In order to take control of the process and make the relevant decision regarding the prescription, pharmacists should understand what constitutes fraudulent practises and work towards eradicating them. Fraudulent prescriptions are caused by legitimate practises, in which patients decide to make alterations to their prescriptions to suit their personal interests (Declerck & Simoens, 2012).

In such cases, the patient may show preference for a particular brand of medicine, and insist that they be treated with the same. In other experiences, patients may also alter prescriptions depending on the cost incurred, in which they either opt for cheaper brands, or prefer more expensive brands due to their perception of higher quality and efficacy. A pharmacist may use their influence in such cases to discover the fraud and alter the prescription, and dispense the right medicine depending on the patient’s conditions (Cornes, 2012).

In addition to cases of alteration, pharmacists also have the technical and professional skills to discover the validity of prescription pads. One of the most conspicuous methods of identifying the validity of such prescription pads may involve subjecting the contact information to a rigor of scrutiny, to determine if they bear the name of the bearer. Such details may include the surnames, contact phone number as well as the registration number (Campanelli, 2012). Professionally, stealing a prescription pads translates into an automatic medical error and a potential adverse reaction. In situations where the pharmacists discover such anomalies, there are a number of professional measures that can be employed to influence the brand of medication prescribed and dispensed.

Pharmacists ensure that they apply strict rules, in which only the state authorised individuals or prescribers can write prescription orders. The state authorized person is defined by the state a trained physician, dentist, veterinarian, podiatrist, as well as other state registered practitioners. For instance, there are states with strict rules in which other health professionals such as physician assistants and nurses to participate in conducting prescriptions under supervision or instruction by the pharmacist in charge. Similarly, other states also permit a sense of autonomy for the mid-level practitioners (Law, et.al, 2012).

The pharmacist therefore has a duty to understand the prevailing laws regarding the state provisions on drug prescription, before determining one. This helps them avoid cases of assumption, in which they perceive that every prescription given for the controlled substances is inappropriate. A pharmacist who obtains a prescription whose validity attracts signs of doubt or appears invalid in any way, it is professional to undertake affirmative steps aimed at establishing the authenticity of the prescription holder (Cornes, 2012). In cases where the pharmacists have doubts about the contact information, they may have to use the prescriber’s contact office, other than the patients contact information. A telephone call to the office creates an additional time in the prescription process, during the concerned parties may address the gaps in the existing prescription. This way, the pharmacist not only gets a chance to influence the types of medication prescribed, but also adheres to the legal requirements, including state laws regarding the use of drugs.

References

Abood, R. R. (2012). Pharmacy practice and the law. Jones & Bartlett Publishers.

Allen, L. V., & Ansel, H. C. (2013). Pharmaceutical dosage forms and drug delivery systems. Lippincott Williams & Wilkins.

Campanelli, C. M. (2012). American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults: The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. Journal of the American Geriatrics Society, 60(4), 616.

Centers for Disease Control and Prevention (CDC. (2012). CDC grand rounds: prescription drug overdoses-a US epidemic. MMWR. Morbidity and mortality weekly report, 61(1), 10.

Cornes, P. (2012). The economic pressures for biosimilar drug use in cancer medicine. Targeted oncology, 7(1), 57-67.

Declerck, P. J., & Simoens, S. A. (2012). European perspective on the market accessibility of biosimilars. Biosimilars, 2, 33-40.

Dylst, P., Vulto, A., & Simoens, S. (2013). Demand-side policies to encourage the use of generic medicines: an overview. Expert review of pharmacoeconomics & outcomes research, 13(1), 59-72.

Garcia-Gollarte, F., Baleriola-Julvez, J., Ferrero-Lopez, I., & Cruz-Jentoft, A. J. (2012). Inappropriate drug prescription at nursing home admission. Journal of the American Medical Directors Association, 13(1), 83-e9.

Gibberson, R. A. D. M., Yoder, C. D. R., & Lee, C. D. R. (2012). Improving Patient and Health System Outcomes through Advanced Pharmacy Practice. A Report to the US Surgeon General. University of the Incarnate Word Pharmacy Review, 1(2).

Haga, S. B., Burke, W., Ginsburg, G. S., Mills, R., & Agans, R. (2012). Primary care physicians’ knowledge of and experience with pharmacogenetic testing. Clinical genetics, 82(4), 388-394.

Law, M. R., Ma, T., Fisher, J., & Sketris, I. S. (2012). Independent pharmacist prescribing in Canada

O’Connor, M. N., Gallagher, P., & O’Mahony, D. (2012). Inappropriate Prescribing. Drugs & aging, 29(6), 437-452.

Rolland, Y., Andrieu, S., Crochard, A., Goni, S., Hein, C., & Vellas, B. (2012). Psychotropic drug consumption at admission and discharge of nursing home residents. Journal of the American Medical Directors Association, 13(4), 407-e7.

Rotenstein, L. S., Ran, N., Shivers, J. P., Yarchoan, M., & Close, K. L. (2012). Opportunities and Challenges for Biosimilars: What’s on the Horizon in the Global Insulin Market?. Clinical Diabetes, 30(4), 138-150.

Spinewine, A., Fialova, D., & Byrne, S. (2012). The role of the pharmacist in optimizing pharmacotherapy in older people. Drugs & aging, 29(6), 495-510.

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A Comparison Between the Contraindications of Omanipaque and Visipaque

A Comparison Between the Contraindications of Omanipaque and Visipaque

            Drugs have a way of relieving the pain and discomfort that patients experience. Some have been specifically made in order to trace the reasons for such discomfort. One of these drugs is known as the contrast agent. However, the contraindications that these drugs may have on people should be taken into great consideration, so as to avoid more discomfort to patients. Two of the most famous contrast agents include Ioxol (Omanipaque) and  Iodixanol (Vispaque).

              The contradindications of Ioxol (Omanipaque) are similar to those of other drugs. However, thyrotoxicosis becomes more visible with every use. People who had previous reactions to the said drug are also contraindicated (GE Healthcare, April 23, 2006). In addition to this, the drug should not be given to patients who are allergic to Iohexol so that allergic reactions may be prevented. When bacteria is present in the body, Myelography is not advised for this may cause the bacteria to spread rather than treated (GE Healthcare Inc., February 2008).

            When the drug is administered orally, the drug may have its effects on the intestines of the patient causing hypovolemia. Younger patients, such as children, would also experience Diarrhea that would eventually lead to hypovolemia. Elderly patients, on the other hand, may experience loss of the plasma fluid that could lead to shock. If not treated accordingly, this would lead to more serious contraindications to patients (Drugs, 2009)

            Similar to Ioxol (Omanipaque), patients who have bacteria in their body should not be given Iodixanol (Vispaque). This may be attributed to the fact that the bacteria would inhibit the effect of the drug on the patient of the body. In addition to this, the drug should not be administered to pregnant and lactating patients for the drug may also have negative effects on the baby (Peace Health, July 25, 2006). Sometimes, it is better to become more careful than to regret the negative effects in the future.

Iodixanol (Visipaque) on the other hand, is more sensitive to patients than Ioxol (Omanipaque). Intake of the said drug would eventually lead to dehydration, and in so doing, patients should be flushed with water while undergoing treatment. This would also help the kidneys to function properly and avoid any damage whatsoever. The elderly patients should also be given special care, especially when handling these drugs. More care should also be given to the renal function of an elderly, so that further complications may be avoided (Med Help, February 11, 2008).

            Furthermore, other diseases may also be attributed to the administration of Iodixanol (Vispaque). Sickle Cell disease becomes visible to patients who have been intraarterially or intravenously injected with the drug. Patients who have a history of Multiple Myeloma and other similar diseases should not be administered with Iodixanol (Vispaque). This would become harmful to their body that may eventually lead to more complications (GE Healthcare Canada Inc., May 25, 2006, p. 7). As such, the patients should always make sure that each procedure conducted in their body should be approved and checked by their attending physicians.

            Evidently, both drugs have similar effects on the body of the patients. One factor that may be considered is their dosage and method of administration to the patients. As contrast agents, both have the same use on the patients. However, their contraindications would become the very basis as to what the physicians would opt to use on the patients.

            Sometimes, it is not bad to be careful when trying to medicate someone. Numerous tests and medical histories may be required before a certain drug may become cleared for administration, but these become the very core for a patient to be alleviated of the pain endured. Drugs are there for their numerous reasons, and regardless of how effective they may all seem, it is always important to put the safety of humans above anything else.

References

(2009). Omnipaque. Drugs.com. Retrieved February 23, 2009 from http://www.drugs.com/pro/omnipaque.html#S3Precautions.

(2009). Omnipaque UK prescribing information. GE Healthcare. Retrieved February 23, 2009 from http://www.omnipaque.com/uk-prescribing-information.shtml.

Peace Health. (July 25, 2006). Iodixanol. Retrived February 23, 2009 from http://www.peacehealth.org/kbase/multum/d04016a1.htm

Med Help. (February 11, 2008). Visipaque. Retrieved February 23, 2009 from http://www.medhelp.org/drugs/Visipaque/show/3022

GE Healthcare Canada Inc. (2006). Visipaque (Iodixanol). Retrieved February 23, 2009 from http://www.gehealthcare.com/caen/md/docs/visipaquepieng.pdf

 

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