Chapter 1 Introduction to Pharmacology - Tagged.pdf

Chapter 1 Introduction to Pharmacology and Drug Regulation  Definitions Pharmacology: is the study of the sources, appearance, chemistry, actions, uses and manufacturing of drugs. Drug: a molecule that can interact with specific molecular components of an organis...

Chapter 1 Introduction to Pharmacology and Drug Regulation  Definitions Pharmacology: is the study of the sources, appearance, chemistry, actions, uses and manufacturing of drugs. Drug: a molecule that can interact with specific molecular components of an organism to cause biochemical and physiologic changes within that organism. Commonly it means any medication used for diagnosing, curing, or treating diseases.  The History of Pharmacology Major pharmacologic developments can be divided into 3 distinct periods: The age of natural substances The age of synthetic substances The age of biotechnology  The Age of Natural Substances Characterized by use of plant derivatives (such as morphine derived from opium) Evolved in China and Egypt 2000 BC – Chinese began using herbs to cure diseases Early records found in Egypt around 1500 BC 300 BC – In Greece, they classified plants by their various parts  The Age of Synthetic Substances Mass production of synthetic medicines (antibiotics, insulin) and drug screening techniques Starting from AD 1350, synthetic substances for medicinal uses continually produced into 20th century Once the molecular structure of a natural drug is identified, it can be synthesized and modified in a laboratory instead of extracting it in its natural form.  The Age of Biotechnology Biotechnology: is the use of proteins from cells and tissues of humans, animals, and plants to produce medicines and therapeutic treatments. Examples include hormone replacement therapy, recombinant DNA technology, and genetic engineering (evolved in early 1970s).  Drug Product Development Can take anywhere from 7 to 15 years Food and Drug Administration (FDA) responsible for regulating: – Foods – Drugs – Cosmetics – Medical devices Before a drug is approved for sale, it must go through several phases of drug development. Stages of Drug Product Development Stage 1 – Preclinical investigation – 1 to 3 years – Animal pharmacology and toxicology data obtained – Investigational new drug (IND) application to the FDA for human testing is required Stage 2 – Clinical investigation (clinical phase trials) – 2 to 10 years – Healthy volunteers are used in large groups to determine drug toxicity and tolerance Stages of Drug Product Development Stage 3 – Investigational New Drug (IND) Review – 2 months to 7 years – The final phase of clinical trials and testing can continue – If IND is rejected, this stops until approved Stage 4 – Postmarketing Studies – Human testing continues in larger, more diverse populations to check for new side effects  Removal of a Drug from the Market FDA: annual public meetings about effectiveness and safety of new drug therapies If a serious problem is discovered, drug must be withdrawn from market; use is discontinued  Prescription Drugs Can only be legally dispensed to a patient with a prescription from a licensed individual Only dispensed by: – Pharmacists – Pharmacy technicians under pharmacist direction – Prescribers  Nonprescription Drugs Also called over-the-counter (OTC) drugs Do not require a doctor’s order Demonstrate wide margins of safety Can have serious side effects if patients do not carefully follow instructions  Controlled Substances Medicinal products with high abuse potential Regulated by the Drug Enforcement Administration (DEA) Only legally be obtained with a doctor’s prescription Include many narcotics (which produce sedative or pain-relieving effects)  Table 1-1: Schedules of Controlled Substances Schedule Manufacturer’s Abuse Potential Prescription Examples Label Requirement I C-I High; no accepted No prescription Heroin, LSD, marijuana, mescaline, medical use permitted peyote II C-II High; accepted medical Prescription Codeine, fentanyl, methadone HCl, use required; no refills methamphetamine, methylphenidate, without new written morphine, deodorized opium prescription III C-III Moderate; accepted Prescription Certain drugs compounded with small medical use required; 5 refills in quantities of narcotics; others with 6 months strong abuse potential (Tylenol® with codeine), certain barbiturates IV C-IV Low; accepted medical Prescription Barbital, chloral hydrate, use required; 5 refills in chlordiazepoxide, diazepam, 6 months pentazocine HCl V C-V Low; accepted medical No prescription Cough syrups with codeine, use required for adults diphenoxylate HCl with atropine sulfate, kaolin/pectin/opium  How does the FDA approve a drug? https://www.youtube.com/watch?v=WUsO6P H_O54 From idea to medicine https://www.youtube.com/watch?v=attNofZ7 AnY