Pharmacology is an expansive and challenging topic.

Pharmacology:

means to study medicine

Pharmacology
The study of drugs
• Improves health if applied properly
Results in devastating consequences if applied improperly

Interrelated Subject Areas
Anatomy and physiology
• Chemistry
• Pathophysiology: Study of disease and functional changes that occur as a result of the disease

• Pharmacology Is a Challenging Topic with Different:
• Drug names
• Interactions
• Side effects
• Mechanisms of action
• Responses

For healthcare providers, the fields of pharmacology and therapeutics are connected.
Healthcare Practitioners That Prescribe Drugs
• Physicians
• Physician’s assistants
• Dentists
• Advanced nurse practitioners

• Nurses Are Healthcare Providers Who
• Administer drugs
• Provide drug education
• Manage drugs
• Enforce drug laws
• Report effectiveness of drugs

Pharmacology And Therapeutics
• Pharmacology is the study of drugs and their use in the body
• Therapeutics is the treatment of diseases
• Pharmacotherapeutics is the use of drugs to treat diseases

Agents may be classified as traditional drugs, biologics, and natural alternatives.
Drugs are Chemical Agents
– Produce biological responses within the body
– Medically therapeutic
• Food, Air, Household Products, Cosmetics are Chemical Agents
– Food and Air are necessary for life
– Household Products, Cosmetics, Chemicals
– Alter the body’s normal activities
§ Not medically therapeutic
§ Examples
• AntiperspirantsOTC Drugs Do Not Require Physician’s Order
• Sunscreens
• Toothpastes
• Shampoos

Drugs are available by prescription or over the counter (OTC).
• Prescription Drugs Require a Physician’s Order
– Healthcare practitioner examines patient
– Healthcare practitioner determines a diagnosis
– Healthcare practitioner orders proper drug

OTC DRUGS
OTC Drugs Do Not Require Physician’s Order
– Do not require a physician’s order
– Margin of safety
******A drug’s safety is related to its effectiveness. The difference between it’s usual effective dose and a dose that produces severe adverse side effects is called its Margin of safety. When drugs have been used over long periods and demonstrate large margins of safety(Aka, very safe and effective), regulators change them from being prescription to over the counter drugs.***********

Prescription vs. OTC
– Advantages
– Advantages
• Proper drug ordered (prescription)
• Amount and frequency controlled ( prescription)
• Instructions on use and side effects (prescription)
• Easily obtained (OTC)
• Less expensive (OTC)

• Prescription vs. OTC
– Disadvantages
Time for doctor’s appointment (prescription)
• More costly (Prescription)
• May choose wrong drug (OTC)
• May not know reactions or interaction (OTC)
• Ineffective treatment and disease progresses (OTC)

Pharmaceutics is the science of pharmacy
• Pharmaceutics
– A science involving:
• Preparation of drugs
• Dispensing of drugs to patients after they are examined by a licensed practitioner
• Not the same as Pharmacology
• Pharmacist
– Prepares drugs
– Dispenses drugs
– Advises about
• Taking drugs
• Side effects of drug
Drug interactions (Under Advices about)

Explain the meaning of this statement: “Pharmacotherapy involves the science of therapeutics and pharmaceutics.”
Pharmacology is the study of drugs and their use in the body
• Therapeutics is the treatment of diseases
• Pharmacotherapeutics is the use of drugs to treat diseases
Pharmaceutics: The science of preparing and dispensing drugs.

MY ANSWER: Pharmacotherapy involves the treatment of disease as well as the science of preparing and dispensing drugs.

Drug regulations were created to protect the public from drug misuse.
Drug regulations were created to protect the public from drug misuse.
• Drug Regulations Needed to Protect the Public(back in the old days from fake concoctions that had not been tested and to make sure that the medicine was not a form of (Quackery).
Quackery: is the promotion of fraudulent or ignorant medical practices.
– Rattlesnake oil for rheumatism
– Epilepsy treatment for spasms, hysteria, alcoholism
Fat reducers for a slender healthy figure

U.S. Pharmacopoeia (is a medical reference summary indicating standard of drug purity and strength and direction for synthesis. )
• Established 1820
• First comprehensive publication of drug standards
• Medical reference summary

National Formulary
List of drugs
• Pharmaceutical ingredients

1852 to 1975 USP and NF maintained drug standards in United States
– 1975 USP and NF merged
Formed USP-NF
Updates published regularly

American Pharmaceutical Association (APhA)
Founded 1852
– National professional society of pharmacists

U.S. Drug Acts
Biologics Control Act 1902
• Standardize quality of serums and blood-related products
– Pure Food and Drug Act 1906
• Government controlled the labeling of medicine
– Sherley Amendment 1912
• Prohibited the sale of drugs with false therapeutic claims
– Food, Drug, and Cosmetic Act 1938
• Prevented marketing of drugs that had not been tested
• Must prove safety and effectiveness of drug

There are four stages of approval for therapeutic and biologic drugs
• Stages of Approval
1: Preclinical investigation
2: Clinical investigation
3: Review of NDA
4: Postmarketing studies
1: Preclinical Investigation
• Basic science research
• Tests on cells and animals
• Drug dose range
• Adverse effects
• Results inconclusive
2: Clinical Investigation
• Involves clinical pharmacology
• Evaluation of human benefit
• Clinical phase trials I and II
• Longest part of approval process
3: Submit NDA
• Review of NDA
• Clinical phase trial III and animal testing continues
• New drug approved or rejected
• Approved – goes on the market
• Rejected – all testing stops
4:Postmarketing studies
• After NDA review completed and approved
• New drug placed on the market
• Check for new harmful effects in larger group of humans
• Drug removed from market if serious problems occur

Pharmacology the study of the origin, use, and chemistry of drugs and their actions and effects in body systems. Also is concerned with the nature of drugs, their effects on living animals, organs, or tissue, drug dosages, drug side effects, …

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Addictive effects Drug interactions in which the effects of a combination of two or more drugs with similar actions is equivalent to the sum of the individual effects of the same drug given alone. For example, 1 + 1 = …

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Canadian Drug Legislation: Food and Drugs Act & regulation ? Health Canada ? Health Canada Products & Food branch ? Classification of therapeutics: Drugs (therapeutic products) Traditional drugs (chemical agents): Pills and tablets etc… Biologics & Genetic therapies Antibodies, Hormones …

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