Pharmaceutical+Products

__Definitions__

 * ** Pharmaceutical Products ** are generally commonplace (either over-the-counter or prescription-based) medicines and drugs, composed fundamentally from both traditional and modern methods. Refer to the World Health Organization link for more information on the definition of a pharmaceutical product. ([|WHO])
 * ** Drugs ** are defined as any natural or synthetic chemical substance that is consumed to alter the functions of the mind or body. (Damji, 2007) These alterations to the natural operating cycles of the human body are used to counteract the effects of disease, bacterial infection, or to provide pleasing effects on the mind and body. To exemplify:
 * Opium is an unhealthy, highly addictive drug that is extracted from the poppy seed. Its consumption produces relaxation and a sense of well-being.
 * Tylenol, on the other hand, is a pain relief, fever reducing and/or allergy relief drug that does not produce dependence.
 * Morphine is a painkilling drug that is used extensively for severe pain. Its consumption may produce dependence.
 * ** Pharmacology ** is the study of the relationship between drugs and their properties with various types of body cells to develop connections between chemical substances and the body's functions. Pharmacologists try to develop substances that can be used to affect the body's working conditions and rates in a positive, healthy manner. ([|VitaminGlossary])
 * Drugs can be divided into three categories according to their origin or synthesis (artificial creation)
 * [[image:http://upload.wikimedia.org/wikipedia/commons/2/2e/Opium_poppy_mohnkapsel.jpg width="289" height="202" align="right" caption="Opium poppies in their natural state." link="http://upload.wikimedia.org/wikipedia/commons/2/2e/Opium_poppy_mohnkapsel.jpg"]] Natural : derived directly from its natural source through simple or complex extraction methods. (i.e. morphine and codein come from the opium poppy)
 * Semi-synthetic : uses the natural chemical compound as an initiating material for the partial chemical synthesis of a drug (i.e. aspirin is derived from salicylic acid).
 * Fully Synthetic : Rather than being produced naturally, it is produced artificially or through complete synthesis (i.e. fentanyl, which is created to be like opium, except it is approximately 100 times more effective than morphine). Synthetic drugs can be engineered to produce the desired reaction with lesser collateral effects. ([|DBL Fentanyl Injection])






 * Chemical Structure of Common Drugs (Morphine - Painkiller) (Aspirin - Analgesic, Fever Reducer) (Fentanyl - Painkiller) ||

**Some of these drugs may be illegal and can thus be possibly lethal for the consumer.** **It is important for the consumer to be aware of the proper intake for a specific drug by asking a professional.** **Non-prescription drugs (over-the-counter) are very easy to abuse. Overdoses may produce harmful effects.** ||
 * = **WARNING: Drugs are not always sold/administered by professional pharmacists or doctors, and do not always have beneficial effects for the individual consuming them. The side effects of a specific drug on a specific patient may be worse than the ailment to be treated by the substance.**

Note: in different cultures, drugs and medicines are defined as different things. They can describe something beneficial or something harmful. The benefits and disadvantages of drugs and medicines are often a controversial, highly debated topic. Different legislations in different countries control the use and consumption of these substances. The decisions of these legislations may prove to be either highly controversial, or very conservative.

__D.1.1 List the effects of medicines and drugs on the functioning of the body.__
__** Effects of drugs on the human body's functions **__

** ﻿ **- Sensations or incoming sensory information are changed
- The production of certain types of cells and/or fluids may be either delayed or accelerated - The body's metabolism, or operating rate, may be affected - The release of chemicals inside the body (ie. stomach acid) may be delayed or accelerated - The release of hormones and chemical messengers may be affected by drugs - Moods or feelings may be affected - Physiological and mental states as well as consciousness, activity level and motor coordination are changed - Come from an eclectic abundance of resources, including variations of plants, modified bacteria, man-made, fungi, blood, etc. (Damji, 2007)

__** Different Types of Drugs **__

 * Body Altering (i.e. metabolism) = vitamins, hormones, antacids
 * Fighters of Infection = antivirals, antiseptics, antibiotics, antibacterials
 * Central Nervous System (CNS) Altering = analgesics, anaesthetics, stimulants, depressants

__** Treatments for Drugs **__

 * The body has its own reagents that defend itself against harmful viruses
 * Haemoglobin (white blood cells) - are produces in bone marrow. White blood cells protect and support the immune system by defending against any harmful substances present inside the human body.
 * ** Chemotherapy ** ﻿ is treatment for diseases or mental illnesses using chemical agents and/or the effects of radiation.

Treatment for Drugs: Placebos //﻿//__﻿__ media type="youtube" key="wsFTgirKXHk?fs=1" height="268" width="448"
 * ** Placebo Effect: ** the effect produced when an individual is given a placebo. In other words, it is the effect of an inert/ineffective substance on humans that exhibits results only because of the psychological effect on the individual (ie. the person believes that a a real drug has been administered, and thus feels better).
 * ** Placebo **: An inert medication or drug that is most commonly used as the control variable in certain experiments.
 * May provide advantages for a patient psychologically when dealing with an illness, and many times makes the body heal itself.
 * Placebo effect can make biochemical procedures in body take place for healing processes
 * Highlights the strong connection between the mind and physical wellness
 * Implications on how a person’s attitude can actually help them in their recovering situation
 * //Body produces natural healing chemicals depending on mood and attitude//
 * //The body may produce symptoms that resemble ill-being according to the mental state/attitude of the person//

__D.1.2 Outline the stages involved in research, development and testing of new pharmaceutical products.__
The stages involved in research, development and testing are complex, expensive, and very long. Drugs are often tested on animals before human testing due to safety reasons. Although controversial, animal testing allows pharmacologists to demonstrate the effects of their drug and tweak them before a human test subject is needed. The following list shows the complete, numbered step process involving the stages in research, development and the testing of new pharmaceutical products:

1). Set aside (or isolate) the new product/active compounds from species such as animals and plants or that have undergone chemical or artificial synthesis. 2). Commence laboratory and clinical pharmacological research (which involves animal as well as plant experimentation) in order to show its efficacy. Changes to the active compound and release mechanism of the drug are tested in this stage. 3). Test its effectual dosage (best known as ED50) and lethal dosage (best known as LD50) rates. 4). Establish its therapeutic index and therapeutic window. (** Therapeutic index **is a comparison of the amount of therapeutic agent that causes the therapeutic effect to the number that causes death. Speaking from a quantitative sense, this would mean that it is the lethal dose of a drug for 50 percent of the population divided by the minimum efficient dose for 50 percent of the population. ** Therapeutic window ** refers to an index for estimation of drug dosage that can beat a disease in an efficient manner while staying in the safety range as well). 5). Test this new drug on humans (half of the volunteers would receive the actual drug, while the other half would receive a placebo). Compare the effects to existing drugs on the market. 6). Process the new product and put it through other, more precise tests before finalizing it and regarding it as completely safe. Once this stage is finalized, the drug can be approved and marketed. 7). Have it approved by the drug administration and have it labeled as either an over the counter or prescription drug. 8) Market the drug and begin large-scale production and distribution. 9) Observe the market reactions and the reactions of individual patients. Some drugs will cause side effects in certain individuals. If the side effect margin is too large for a certain percent of patients, the drug may be discontinued and a new ne may be formulated.

The diagram below will show you a a simplified version of the steps above:



__D.1.3 Describe the different methods of administering drugs.__

 * In order to administer any drug, the active element must be introduced to the blood stream - as a reference, the entire blood volume of a human being is approximately six liters. For a drug to be effective, it needs to occupy a certain parts per million (PPM) of the bloodstream.
 * Methods of drug administration differ in effectiveness depending on how quickly the substance reaches the bloodstream.
 * Some methods of drug administration may affect the effectiveness of the drug depending on the patient's individual characteristics (ie. the effectiveness of orally administered drugs can change according to the stomach's acid content).
 * Some methods of administration require a "buffer" amount, since some of the drug is neutralized or neutrally absorbed by the body without producing any effect. This buffer ensures that "at least" an appropriate amount has been actively introduced into the system and is having an effect.
 * The human body circulates its entire blood volume about once per minute. Thus, intravenous medicines are distributed evenly and quickly.

([|Merck Manuals])

__D.1.4 Discuss the terms therapeutic window, tolerance, and side effects.__

 * Therapeutic window: ** It is a measure of the safety of a new drug made for a typical population. Quantitatively speaking, it is the ratio of the lethal dose (LD50) to the therapeutic dose (ED50). If the effective dose is small and the lethal dose is large then this means that a wide therapeutic window exists meaning that the toxicity occurs at higher concentrations and is above the dose desired for an effective effect. These drugs may be administered with a larger margin of error. Similarly, when the therapeutic window is narrow, then this means that small doses must be tested for success. These drugs will have to be administered with a very small margin of error in order to avoid overdosing.



The diagram below presents a simplified version of what has been said above:




 * Tolerance: ** Refers to how over time due to regular usage of a drug, a user needs increasing amounts of a drug in order to get a satisfying physiological or physical effect. Tolerance increases the risk of an overdose for two reasons. The first one being that the brain is capable of turning off the chemical receptors involved with the absorption of a drug. In other words, the body does not always develop tolerance to the harmful effects of the drug. Secondly, if a user hasn't taken a drug in a long time, the tolerance may have decreased meaning that after some time of no drug consumption, the size of the dose the user had been used to may now be enough to cause an overdose.


 * Side Effects: ** Side effects are the opposite of desired effects, meaning they are the undesired responses occurring from taking a drug. They can sometimes be beneficial or harmful to a drug consumer. The ideal drug must have the least side effects compared to the potency of its curing power.

Most drugs have side effects. Very few pharmaceutical products have no appreciable side effects. Usually, a product's side effects are insignificant and should not cause trouble or discomfort. However, certain individuals react different to chemical compounds. There will always be patients that react negatively or even develop an allergic reaction to a drug or medicine.


 * //The image below shows the possible side effects (undesired effects) of a single, common drug. (Tramadol)//**



media type="youtube" key="YXE_f-UXPkg" width="425" height="350"

**__Works Cited__**
Damji, Sadru, and John Green. //IB Higher Level Chemistry//. Illus. IBID Press and Authors. Comp. Chris Houlahan and Colin Flashman. Ed. Chris Talbot, Neville Lawrence, and Science Teaching and Resources. International Baccalaureate Organization, 2007. PDF file. Kopacek, Karen Birckelbaw, RPh, ed. “Administration and Kinetics of Drugs.” //Merck Manuals//. Ed. Merck & Co. Inc. Merck Sharp & Dohm Corps. , 2010. Web. 14 Jan. 2011. . World Health Organization, comp. “Pharmaceutical Products.” //World Health Organization//. Berne Convention for the Protection of Literature and Artistic, 2010. Web. 25 Dec. 2010. [].

For more information please refer to the following web sources: [] []