Improve Quality of Life
Produce Devastating Consequences
2. Compare and contrast pharmacology and therapeutics.
a. Pharmacology: The study of medicine.
i. Understanding how drugs are administered, to where they travel in the body, to the actual responses produced. b. Therapeutics: branch of medicine concerned with the prevention of disease and treatment of suffering c. Pharmacotherapy: application of drugs for the purpose of disease prevention and the treatment of suffering. Use of drugs to diagnose, prevent, or treat disease processes/suffering 3. Identify the role of the FDA in U.S. drug regulations and drug approval process. a. Exercises control over prescription and OTC drugs b. Seeks to provide clear information for safe use
c. All labs must obtain FDA approval before a drug can be marketed. d. Testing phases include:
i. Preclinical investigation: involves extensive laboratory research. Tests are performed on human and microbial cells cultured in lab. Important because allows predictions to be made whether drug will harm human. Results are always inconclusive. ii. Clinical investigation: takes place in three different stages termed clinical phase trials. 1st: tests performed on healthy volunteers to determine dosage and assess for adverse effects. 2nd: involve large groups with the disease. 3rd: involve 1,000 to 3,000 patients in hospitols and clinical agencies. iii. Review of the New Drug Application: The drug brand name is finalized. Clinical phase 3 trials may continue depending on the results obtained preclinical testing. By law, the FDA is permitted 6months to initially review an NDA. If approved, process continues to final stage. If rejected, the process is suspended until noted concerns are addressed by company. iv. Postmarketing surveillance: the final stage of the drug approval process begins after clinical trials and the NDA review have been completed. Purpose of this stage is to survey for harmful drug effects in a larger population. Some adverse effects takes longer to appear and not identified until a drug is circulated to large number of people. 4. Identify advantages/disadvantages of prescription and over-the-counter medications. a. Advantages of Prescription: requiring authorization. Physician can examine patient and determine specific diagnosis. Maximize therapy by ordering proper drug for the patients condition, and by conveying amount and frequency of drug. HCP can teach patient proper use of drug and potential side effects. b. Advantages of OTC: obtained more easily. NO appointment with a physician is required. c. Disadvantages of OTC: choosing proper drug for a specific problem can be challenging. OTC drugs may react with foods, herbal products, prescriptions, or other OTC drugs. Also OTC drugs can cause impairing to ability to function safely. Self-treatment is sometimes ineffective and the potential for harm may increase if the disease is allowed to progress. 5. Describe the role of the U.S. DEA in management of controlled substances. a. Hospitols and pharmacies must register with the DEA and then use their assigned numbers to purchase scheduled drugs. Hospitals and pharmacies must keep complete records or all quantities sold and purchased. Drugs with higher abuse potential have more restrictions. The DEA regulates and monitors drug use so no one can abuse controlled substances. 6. Identify chemical, generic, and trade names of medications. a. Chemical: assigned name using standard nomenclature established by the IUPAC. Drug has only one chemical name. Example for diazepam:...