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Drugs
Generic Drugs
What is a drug?
What is Medication?
How are drugs named?
What is a generic drug?
Who makes generic drugs?
Are generic drugs as reliable as the brand name product?


What is a drug?

A drug is a substance which may have medicinal, intoxicating, performance enhancing or other effects when taken or put into a human body or the body of another animal and is not considered a food or exclusively a food.

Medication

A medication or medicine is a drug taken to cure and/or ameliorate any symptoms of an illness or medical condition, or may be used as preventive medicine that has future benefits but does not treat any existing or pre-existing diseases or symptoms.

Administering drugs, both medicinal and recreational, can be administered in a number of ways. Many drugs can be administered in a variety of ways rather than just one.

Bolus
Inhaled, (breathed into the lungs), as an aerosol or dry powder. (This includes smoking a substance) Injected as a solution, suspension or emulsion either: intramuscular, intravenous, intraperitoneal, intraosseous.
Insufflation, or snorted into the nose.
Orally, as a liquid or solid, that is absorbed through the intestines.
Rectally as a suppository, that is absorbed by the rectum or colon.
Sublingually, diffusing into the blood through tissues under the tongue.
Topically, usually as a cream or ointment. A drug administered in this manner may be given to act locally or systemically.
Vaginally as a suppository, primarily to treat vaginal infections.

What is Medication?

A medication is a substance that is taken into or placed on the body that does one of the following things:
Most medications are used to cure a disease or condition.
For example, antibiotics are given to cure an infection.
Medications are also given to treat a medical condition. For example, anti-depressants are given to treat depression.
Medications are also given to relieve symptoms of an illness.
For example, pain relievers are given to reduce pain. Vaccinations are given to prevent diseases. For example, the Flu Vaccine helps to prevent the person from complications of having the flu.

How Do Medications Work?

Medications get into the body in a number of different ways. The way the medication enters the body is called the "route".

The most common "route" for medications is orally (by mouth) in the form of pills, capsules or liquids. However, if the person is unable to take medications in this way, or if the medication is not available in oral form, medications can enter the body by other routes.

Here are some of the different routes:

Medication Effects

Local Effect: Some medications, such as eye drops or topical skin creams or ointments, are applied directly to the area that needs treatment.

These applications tend to have a very localized effect and do not usually enter the bloodstream in significant quantities.

For example: antibiotic ointment is applied to a scrape on the skin. The ointment stays on the surface of the skin, where the medication effect is needed. Systemic Effect: Some medications, such as pills or liquids given orally, rectal suppositories,

Transdermal patches and subcutaneous injections end up in the bloodstream and act on a specific organ or system within the body.

These medications are said to have a systemic effect. For example: anti-depressant medications taken orally are circulated through the bloodstream and work by increasing the amount of certain chemicals in the brain.

How Medications Affect You

A medication may have several types of effects on your body:
- Desired Effect
- Side Effect
- Tolerance and Dependence
- Interactions
- No Apparent Effect
- Paradoxical Effect

The desired effect is also called the therapeutic effect. This means that the medication is doing what it is supposed to.

Almost all medications that have a systemic effect on the body will cause side effects. Some medications that have a localized effect on the body can also cause side effects.

Side effects are the symptoms that result from a normal dose of a medication. Most side effects are not serious and some may decrease as the body becomes used to a medication. For example, some blood pressure medications, because of the way that they act on the heart, can cause the person to feel tired. Other medications can cause side effects such as dry mouth, stomach upset or headache. Side effects to anti-psychotic medications can include severe extrapyramidal reactions and tardive dyskinesia. These symptoms mimic Parkinson’s disease and are caused by damage to the brain.

Other side effects such as adverse effects can be much more serious.

An adverse effect may be related to an increased dosage of a medication or when a medication accumulates in the body, causing toxicity. Toxicity can damage tissues and organs and can also, in some cases, lead to death. For example, some seizure medications and some psychiatric medications require monitoring for adverse physical symptoms and monitoring through blood tests to make sure that the level of medication in the body is not toxic. For instance, lithium toxicity can occur at doses close to therapeutic levels AND CAN RESULT IN DEATH. It is also very important to think about an individual’s fluid intake. If a person becomes dehydrated and is taking lithium or other drugs such as Tegretol or Depakote, the levels of these medications in the blood will increase and can possibly cause toxicity, and can result in death.

Additionally, lithium interferes with the regulation of sodium and water levels in the body, and can cause dehydration and result in increased lithium levels. There are several drugs that when taken require regular monitoring of blood levels. For example, those who use lithium should receive regular blood tests and should monitor thyroid function annually and kidney function for abnormalities.

Severe allergic reactions to medications can occur, sometimes called “anaphylactic reactions” or “anaphylaxis,” and can be life-threatening. Medication tolerance can happen when, over time or with repeated dosages, the individual's response to the medication is decreased.

For example: Certain medications that are taken for a long time can cause the body to adapt to them. Tolerance is good when it means that the body has adapted to the minor side effects of the medications. Tolerance can be a problem if it makes the medication less effective so that a higher dose of the medication is needed.

Medication dependence is when an individual develops a physical or psychological need for a medication. For example: People who take laxatives for a long time can become physically dependent on the laxatives in order to have a bowel movement because the body loses the ability to work without it. A person can also develop a psychological dependence on anti-anxiety medications and think that they cannot function without taking the medication on a regular basis. Interactions can occur between medications or between medications and food.

For example: Two or more medications given together can produce a stronger response. Sometimes this is intended, and purposely ordered by the health care provider. Other times, it is not intended and can be harmful.

Two or more medications given together can reduce or cancel out the effect of one or more medications. Sometimes this is intended; other times it is not and can be harmful.

The two types of medication interactions noted above are most likely to occur when the health care provider is not aware of all of the medications that the individual is taking.

Some medications are specifically given with food or with milk. Other medications are specifically ordered to be taken before meals. Some medications must be given with a full glass of water. It is important to ask the pharmacist if certain liquids should be given with the medication.

If you believe that the medication is showing no apparent effect (that it is not working) because the individual's symptoms have not improved or gone away, the health care provider should be notified. Sometimes medications work in an opposite way. This is called a paradoxical effect.

For example: Benadryl usually causes a person to become tired or drowsy. An example of a paradoxical effect to Benadryl might be that the individual becomes hyperactive or agitated.

Any symptom that is unexpected or unusual must be reported immediately following your agency's policy or procedure.

It is not your responsibility to figure out what is wrong with the individual. This is the responsibility of the health care provider.

It is your responsibility to observe the individual carefully and to document and report all medication effects.

Medication Monitoring: Blood Levels and Other Blood Tests

As mentioned previously, some medications require careful monitoring through blood levels or monitoring of other blood tests: this is done by the laboratory or doctor's office by taking a blood sample from the individual. It is very important that you understand what medications require blood level monitoring! Things to remember about medication blood levels and other blood tests:
• Drugs such as lithium, Depakote, and Tegretol can reach toxic levels in a person’s blood stream and even cause death.

• Ask the prescribing practitioner if a blood level or other blood test is needed for the medication(s) that the individual is taking.

• Ask if there is a certain time of day that the blood sample should be taken.

• Ask if medication should be given before the blood sample is taken. Some medication blood levels require that you “hold” the medication until after the blood sample has been taken.

• If you have been asked to "hold " the medication until after the blood sample has been taken, don't forget to give the medication after the blood test is done.

• Document in the individual's record when blood levels have been ordered.

• Document in the individual's record when you take the person to the laboratory or doctor's office to have the blood sample taken.

• Ask if it is OK for the individual to have food or liquids before the blood test is done. Sometimes it is necessary for the individual to "fast" (have nothing to eat or drink) until after the blood test has been done.

The Medication Cycle

Providers who are authorized to administer medications play a key role in the use of medications for individuals.

You must observe individuals and determine if the medication appears to be working.

Your determinations are based on knowledge of why the medication is being given, what the desired effect is and what to do if that effect is not achieved. The medication cycle shows the basic steps for monitoring, reporting and following up on symptoms and medications.

The cycle does not end. It is continuous which means that you are constantly observing, monitoring and reporting to the appropriate persons the effects of medications on individuals.

Some changes can be very obvious; others are not. The only way to make sure that all changes are noted is to carefully observe the individual and document and report any changes that you see.

How are drugs named?

Most drugs have three names:

  • a chemical name
  • a generic name
  • a brand name
Generic Drugs

What is a generic drug?
A generic drug is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient.

A generic drug is a copy of a brand name drug whose patent has expired. The original manufacturer of a drug receives a patent on the drug and is the only manufacturer who can produce and sell the drug during this patent period. Once the patent expires, other manufacturers may produce and sell the drug. These manufacturers usually sell the drug under its common or generic name.

Since chemical names are usually long and complicated, the drugs are given a standard, shorter generic name. Manufacturers will usually give drugs brand names to identify that manufacturer's version of the product. An example of these three names, using a well known prescription drug is as follows:
chemical name — 7-chloro-1,3-dihydro-1- methyl-5-phenyl-2H-1,4-benzodiazepin-2-one;
generic name — diazepam; and
brand name — Valium.

How do I know if my pharmacist used a generic drug on my prescription?
_________ law requires the pharmacist to indicate that a generic drug has been substituted for a brand name drug by placing on the container the statement, "Substituted for Brand Prescribed," or "Substituted for Brand Name," where Brand Name is the actual name of the brand name product prescribed, e.g., "Substituted for Valium." If you have a question about a specific prescription, ask your pharmacist.

How do I request that my prescriptions be issued for generic drugs?
Ask your doctor to indicate on your prescription that a generic drug may be used.



Who makes generic drugs?
Are generic drugs as reliable as the brand name product?

What's In a Name?

Chemical Name

Generic Name

Brand Name

N-(4-hydroxyphenyl) acetamide

Acetaminophen

Tylenol

7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one

Diazepam

Valium

4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone

Haloperidol

Haldol

5-thia-1-azabicyclo [4.2.0]-oct-2-ene-2 carboxylic acid, 7-[(aminophenylacetyl)amino]-3-methyl-8-oxo-, monohydrate

Cephalexin

Keflex, Keforal, or Keftabs

dl-threo-2-(methylamino)-1-phenylpropan-1-ol

Pseudoephedrine

Sudafed

N''-cyano-N-methyl-N'-[2-[[(5-methyl-1H-imidazol-4-yl) methyl]thio]ethyl]guanidine

Cimetidine

Tagamet



Are generic drugs as reliable as the brand name product?

All drugs considered to be generically equivalent to a brand name product must meet strict manufacturing requirements set by the Federal Food and Drug Administration (FDA). These requirements include tests which assure that the product is bioequivalent to the brand name product. Bioequivalent means that the same amount of active ingredient is delivered to the body at the same time, and used by the body, in the same way as the brand name product. Therefore, generically bioequivalent drugs should produce the same results as the brand name product.

How do I know if my pharmacist used a generic drug on my prescription?

_________ law requires the pharmacist to indicate that a generic drug has been substituted for a brand name drug by placing on the container the statement, "Substituted for Brand Prescribed," or "Substituted for Brand Name," where Brand Name is the actual name of the brand name product prescribed, e.g., "Substituted for Valium." If you have a question about a specific prescription, ask your pharmacist.

How do I request that my prescriptions be issued for generic drugs?

Ask your doctor to indicate on your prescription that a generic drug may be used.

Do I have a choice? Can I ask the pharmacist NOT to substitute a generic drug for a brand name drug on my prescription?

Yes, you have the right to refuse a generic substitution. The pharmacist must then dispense the brand name drug.

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How Long Do Drugs Stay in Your System?

Here are further guidelines.