Pharmacology

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the study of the effects of chemical substances on living tissue.

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pharmacology

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regulates prescription drugs in the United States, agency of the US Department of Health and Human Services.

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Food and Drug Administration (FDA)

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passed to protect the public by controlling the
sales of drugs which were adulterated, dangerous and falsely labeled, first step taken to make drugs safer but did little to ensure effectiveness

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The Federal Food and Drug Act

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was designated as the official publication for drug standards

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States Pharmacopeia

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designated as the official listing of all drugs legally available in the
United States

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National Formulary

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passed to prohibit drug
companies from making false claims about their products.

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The Federal Food and Drug Act- Sherley Amendment

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defined the legal term “narcotic” and regulated the
importation, manufacturing and sale of opium, cocaine and their derivatives. This was the first narcotic act for any nation.

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Harrison Narcotic Act

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amended and renamed the Federal Food,
Drug and Cosmetic Act

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The Federal Food and Drug Act

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This legislation was prompted by more than 100 deaths in 1937 from a toxic sulfanilamide elixir. Pharmaceutical companies were mandated to submit an investigational new drug (IND) application to the Federal Food and Drug Administration (FDA) and conduct toxicity testing in laboratory animals before marketing new drugs. The FDA was empowered to approve and recall drugs.

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Federal Food,
Drug and Cosmetic Act

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distinguished between prescription (legend) drugs and over-the-counter (OTC) drugs. Legend drugs bear the inscription “Caution – Federal Law prohibits dispensing without a prescription.” This Act also specified that certain controlled substances could not be refilled without a new prescription. Another feature of this legislation was to restrict dispensing of prescription drugs to licensed pharmacists. Physicians and certain other health care practitioners prescribe medications and nurses administer medication.

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The Federal Food, Drug and Cosmetic Act- Durham-Humphrey Amendment

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required that drugs be effective as well as safe. The issue of drug companies making false claims about their products was revisited. Also, at this time the drug thalidomide was being used in Europe as a sedative-hypnotic. Over 3500 severely deformed babies were born to mothers who had used this drug during pregnancy. In response to this tragedy, pregnancy safety categories were developed.

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Federal Food, Drug and Cosmetic Act-Kefauver-Harris Amendment

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categorized addictive drugs into five schedules according to their abuse potential. Schedule I drugs are considered to be the most addictive and are not legally available in the United States. Each succeeding schedule theoretically has less abuse potential. Narcotics were now referred to as controlled substances. The Drug Enforcement Agency (DEA) is responsible for the enforcement of legislation concerning controlled substances. Governmental programs to prevent and treat drug abuse were established.

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Comprehensive Drug Abuse Prevention and Control Act

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was passed after capsules of Tylenol were poisoned. Over-the-counter drugs have to be packaged in such a way that it is obvious to the consumer if the container has been opened.

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Tamper Proof Packaging Requirement

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offered substantial tax credits to pharmaceutical companies to develop drugs to treat rare diseases or which have a limited market.

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Orphan Drug Act

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enabled pharmaceutical companies to manufacture and market a drug under the generic name and to apply their own trade name once the patent held by the original manufacturer expired. It takes about 14 years at a cost often in excess of $980 million to bring a new drug to market. To help drug manufacturers recoup these costs, a patent is granted for approximately 13 -17 years. Other manufacturers can market the drug once the patent expires.

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Generic Drug Law

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allowed workers and their families to maintain their health insurance coverage with the change or loss of a job. The coverage is at the worker’s expense and can be kept up to 18 months unless a new policy is obtained. The coverage can be extended to longer periods in some cases of disability.

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Consolidated Omnibus Budget Reconciliation Act (COBRA)

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enabled the review process of investigational new drugs to be accelerated if the drugs will be used to treat HIV, AIDS or cancer.

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Drug Relations Act

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established national standards for electronic health care data. Primary objective was to streamline Medicare claims and reimbursements. New safeguards were put into place to protect clients’ confidentiality. Individuals were given rights to access their medical records.

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Health Insurance Portability and Accountability Act (HIPPA)

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required testing of certain drugs for safety and effectiveness in children

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Pediatric Research Equity Act

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provides financial assistance to senior citizens to purchase prescription drugs. This is Medicare Part D.

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The Medicare Prescription Drug Improvement and Modernization Act

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based on the major objectives of increasing accessibility and affordability of health care insurance coverage

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Comprehensive Health Care Reform Act

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This phase applies only to drugs that are administered through the gastro-intestinal tract. This includes drugs that are taken by mouth, through naso-gastric, gastric, duodenal or jejunal tubes. During this phase, drugs in solid form (tablets and capsules) are disintegrated and dissolved by fluids in the stomach and small intestine. Drugs in liquid form (suspensions and elixirs) are already disintegrated. These preparations will pass through the pharmaceutical phase quickly.

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PHARMACEUTICAL PHASE

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This phase applies to all drugs and is characterized by movement of the drug

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PHARMACOKINETIC PHASE

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The first aspect of the pharmacokinetic phase is _____- is defined as the movement of a drug from its site of entry into the body to the blood stream. The second aspect of the pharmacokinetic phase is _____ - is defined as the movement of the drug from the blood stream to the interstitial space of tissues and then into the cells.

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[PHARMACOKINETIC PHASE] absorption, distribution

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This phase also applies to all drugs and is characterized by bio-chemical actions of drugs and physiological responses to drugs. Drugs modify existing functions of target tissues. They can stimulate (agonists) or inhibit (antagonists) cellular function in the body. Some drugs are used as replacement therapy when endogenous substances such as thyroxine, insulin or estrogen are diminished or absent. Other drugs are used as dietary supplementation such as vitamins, minerals or electrolytes.

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PHARMACODYNAMIC PHASE

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Following the pharmacodynamic phase, the drug is on the move again

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PHARMACOKINETIC PHASE

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The third aspect of the pharmacokinetic phase is _____- drug undergoes enzymatic transformation in the liver. The fourth aspect of the pharmacokinetic phase is _____- during metabolism, the drug is transformed to a water-soluble form so it can be excreted by the kidneys.

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[PHARMACOKINETIC PHASE] metabolism (biotransformation), excretion

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Some tablets and capsules have properties that allow rapid disintegration and dissolution while others have properties that delay these processes. Sustained-release preparations have coatings that dissolve at variable rates. Enteric coated preparations are designed to resist disintegration in the acid environment of the stomach but will break down in the alkaline environment of the small intestine. Breaking or crushing sustained-release or enteric preparations will cause them to lose some or all of this function

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Type of Drug Preparation

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Most oral drugs are disintegrated and dissolved more readily in fluid with a low pH (acidic) such as that found in the stomach

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pH of the Gastric Fluid

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Tablets and capsules can stick to the tongue, lodge in the buccal space or become stuck in the esophagus. This must be monitored closely with elderly, debilitated and confused clients

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Incomplete Swallowing

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Rapid movement of a drug from the stomach to the small intestine speeds the absorption process while slow movement of a drug from the stomach to the small intestine delays absorption.

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Gastric Motility

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reduces the absorption of iron and tetracycline.

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milk

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enhances absorption of iron

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orange juice

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slows the metabolism of calcium channel blockers and certain other drugs.

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grapefruit juice

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decrease the absorption of many drugs.

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Foods rich in calcium and iron

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decrease the absorption of most drugs

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Products containing aluminum (antacids)

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decrease the effectiveness of the anti-coagulant warfarin sodium (Coumadin)

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Foods rich in vitamin K

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given together, neither might be absorbed.

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iron and levothyroxine (Synthroid)

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Drugs have a range of minimum to maximum doses that will exert a therapeutic response. A dose that is too small is sub-therapeutic. There is also a maximal point where a larger dose will not provide any further benefit. A dose that is too large can be toxic.

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Dose Response:

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evidence that a drug is exerting a therapeutic response.

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Efficacy

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thought to occur with the activation of excess drug-metabolizing enzymes and/or decreased sensitivity at the receptor sites. Over time, larger doses of a drug are needed to achieve the same effect

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Tolerance

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tolerance to drugs in the same pharmacological family e.g. morphine and codeine

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cross-tolerance

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The time it takes the drug to reach the minimum effective concentration in the plasma after it is administered. Pharmacological action begins at this time.

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Onset of Action

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The drug reaches the highest level of concentration in the plasma. It is most active at this time.

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Peak Action

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The ratio between the effective dose and the lethal dose. A drug with a narrow therapeutic index may be effective and useful but is also dangerous.

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Therapeutic Index

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The ratio between the minimum effective concentration and the minimum toxic concentration. The therapeutic range is monitored for drugs with a narrow therapeutic index. The monitoring is accomplished through periodic blood tests.

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Therapeutic Range

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another measurement of the blood levels of a drug

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Peak and Trough Levels

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To measure _____, blood is drawn at the time the drug should be reaching its highest level, indicates the rate of _____.

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peak levels, absorption

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The _____ is drawn just before the next scheduled dose is administered, should be much lower than the peak level and indicates the rate of _____.

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trough level, excretion

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The time it takes for one-half of the drug to be eliminated from the body.

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Biologic Half-Life (t ½ )

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A large initial dose that is given to quickly achieve a therapeutic blood level of a drug. Often used for drugs which are slow to reach a therapeutic concentration in the blood

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Loading Dose

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Drugs act on desired as well as some undesired receptor sites. The effect on the desired receptor site is the _____.

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primary effect

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The effect on the undesired receptor site is a _____ and usually _____.

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secondary, undesirable effect

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A physiological response that is harmful to the body, can be potentially life-threatening such as an allergic response

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Adverse Reaction

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An unexpected response from a drug. For example, a sedative might cause nervousness or excitement in some individuals

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Idiosyncratic Response

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Repeated doses of a drug accumulate in the body resulting in a greater than desired pharmacological effect. Drugs might accumulate in drug “reservoirs” such as bone, adipose tissue and the liver. _____ also occurs when excretion of the drug is decreased.

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Cumulation

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Two or more drugs with similar actions are given simultaneously to increase the pharmacological effect.

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Summation (additive effect)

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Two or more drugs with dissimilar actions are given simultaneously to create a pharmacological effect that is greater than the sum of the drugs when given independently.

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Potentiation (Synergism)

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There is an indication that a particular drug should not be given

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Contraindication

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The client deviates from the therapeutic regimen due to such factors as lack of knowledge, lack of commitment or environmental factors that interfere with therapy.

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Non-Adherance/Non-Compliance

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The term _____ refers to untoward events resulting from therapeutic interventions.

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iatrogenic

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Nausea, vomiting, diarrhea, gastric mucosal irritation, stomatitis.

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Gastro-Intestinal Effects

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A decrease in the red and/or white blood cells (blood dyscrasias). Monitor CBC

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Hematologic Effects

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Monitor for ↑ in the liver enzymes such as the AST, ALP, ALT

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Hepatotoxicity

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Monitor for ↑ in the blood urea nitrogen (BUN) and the serum creatinine.

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Nephrotoxicity

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Weight gain, hyperglycemia, fluid and electrolyte imbalances. Steroids can cause these effects.

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Metabolic Effects

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Rashes, itching, changes in pigmentation

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Dermatologic Effects

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Increased reaction of the skin to the sun

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Photosensitivity

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Capable of causing cell mutation leading to carcinoma (cancer).

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Carcinogenic Effects

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Causes developmental disorders in the fetus

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Teratogenic Effects:

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There is no evidence of risk to the human fetus

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Teratogenic Effects- Category A

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Animal studies have not demonstrated a risk to the fetus. Well-controlled studies in pregnant women are not available. It is assumed that there is little to no risk to the fetus.

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Teratogenic Effects- Category B

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Animal studies have shown an adverse effect on the fetus but there are no adequate studies in humans or there are no animal reproduction studies. The drug may be given if the potential benefits to the mother outweigh the potential risks to the fetus.

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Teratogenic Effects- Category C

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There is evidence that there is risk to a human fetus. The drug may be given if the potential benefit to the mother outweighs the potential risk to the fetus.

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Teratogenic Effects- Category D

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Animal and/or human studies demonstrate fetal abnormalities or adverse reactions. The risk to the fetus outweighs the potential benefits to the mother.

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Teratogenic Effects- Category X

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Many drugs are secreted into the breast milk and have the potential of affecting the baby. Any breast – feeding mother must be informed to check the ability of a drug to be secreted in breast milk.

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Secretion of Drug Into Breast Milk:

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Occurs within minutes of exposure to the allergen. Is usually characterized by pruritis, rash, urticaria and/or edema. Serious reactions can include apprehension, tachycardia, hypotension, bronchospasm and respiratory tract edema. This is anaphylactic shock and can be fatal. Treated with diphenhydramine (Benadryl), epinephrine and/or corticosteroids such as hydrocortisone (Solu-Cortef) IV.

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allergic reaction- type I

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Is characterized by an auto-immune response. Hemolytic anemia, thrombocytopenia or lupus erythematosus can be seen. This reaction is usually reversible weeks to months after the drug is discontinued.

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Allegric reactions- Type II

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Is characterized by fever, swollen lymph nodes, arthralgia and enlarged spleen. Usually occurs 1 – 3 weeks after exposure to the drug.

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Allergic reactions- Type III

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Caused by sensitized T lymphocytes. Results in contact dermatitis. Pruritis, rash and urticaria occurs when touching the allergen. Many health care professionals have developed this type of allergic reaction to latex gloves.

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Type IV