2.1 Pharmacology Safety and Quality Flashcards
Pharmacology
Study of drugs that alter functions in living organisms.
Drug Therapy
Use of drugs to prevent, diagnose, treat signs, symptoms and disease processes
- Prevent (Vaccinations)
- Diagnosis (Tuberculin Skin Test)
- Treatment (Antibiotics, Antihypertensives)
Medications (Local/Systemic)
Medications - Drugs given for therapeutic purposes
Local Medications - Act mainly at the site of application. Usually does not enter blood stream in significant quantities. (Ointments, Local Anesthetics)
Systemic Medications - Taken into the body and circulated via bloodstream to sites of action and eventually eliminated from body. (Oral/Rectal Medication, Transdermal Patches, Injections)
Where Medications are Derived`
Plants - Come from leaves, roots, seeds, barks etc. (Example) Digitalis from Purple Foxglove, Morphine from opium poppy, Vincristine from Periwinkle.
Animals - Come from body fluid, secretions or glands. These are less common now with genetically engineered drugs.
(Example) Insulin, Heparin, Adrenaline, Thyroxin, Antitoxin.
Minerals - Required for body to maintain homeostasis
(Example) Electrolytes, Ferrous Sulfate for Iron Deficiency, Radioactive Iodine to Diagnose and treat disorders.
Synthetic Compounds - Produced in a lab (Majority of drugs Synthetic/Semi-Synthetic)
(Example) Oral Penicillin and Morphine derivatives.
Biosynthetics - Genetically engineered. Newest methodology for drug development.
Drug Class
Group of medication with similar..
- Chemical Structures
(Morphine is an Opiate because it comes from Opium Plant)
- Physiological Properties
(What the drug does to the body - Morphine is a CNS Depressant)
- Mechanisms of Action
(Involves Pharmacokinetics and pharmacodynamics. Relates to how the drug effects cell function like cell growth, enzymes, or receptors)
- Therapeutic Uses
What the intention is for a given individual
(Morphine is an analgesic. Morphine is a CSN Depressant, and opiate analgesic)
Drug Prototype
First drug of a particular group to be developed.
(Morphine was the first for Opioid Analgesic)
(Penicillin was the first Antibacterial Drug)
Drug Names
Chemical Name - Describes Chemical Structure of Drug
(Too long and complex for everyday use)
Generic Name - Chemical/Official Name
(Usually all lowercase letters)
(United States Adopted Name Council assigns generic names in USA)
Brand (Propriety/Trade) Name - Name of the manufacturing company of the specific drug. Generics are often less expensive than Trade Name drugs. (Usually Capitalized)
Special precautions for drugs
You can use both Trade or Generic name when prescribing but Generic is becoming the norm
US Drugs and Drugs outside the US may have different active ingredients. Different manufactures can have different inactive ingredients for the same product
Prescription/OTC Drugs
Prescription - Drugs must be prescribed
OTC - Accounts for 60% of all drugs administered. 40% of Americans take at least 1 OTC drug every 2 days. 4 times as many illnesses are treated by consumers using an OTC drug than visiting physician.
FDA
Regulates
- Food
- Drugs
- Cosmetics
- Medical Devices
Drug Legislations
1906 - Federal Pure and Drug Act
(Weak law saying drugs must be free of adulterants)
1938 - Food, Drug, Cosmetic Act
(Stronger act - First to legislate drug safety)
1962 - Kefauver-Harris Amendment
(Drugs must have benefit. Start of drug testing)
*1970 - Controlled Substance Act
(Regulates manufacturing and distribution of drugs that have the potential for abuse)
Drug Legislations (cont)
1992 - Prescription Drug User Free Act
(Permitted accelerated approval of drugs for AIDS and Cancer)
1997 - FDA Modernization Act
Added drugs for Fast-Track Approval Process for serious illnesses
2002-2003 - Best Pharmaceuticals for Children Act
2007 - FDA Amendments Act
Most Important Legislation for Drug Safety since Kefauver-Harris Amendment.
2009 - Family Smoking Prevention Tobacco Control Act
FDA Can regulate cigarettes. (Responsible for 1/5 deaths in USA each year)
FDA
- Created in 1931
- Ensures safety and efficacy of drugs before marketed
Black Box Warning - Strongest safety warning drugs can carry while remaining on the market. Notes serious side effects of drugs.
How Chemicals Become Drugs
(Preclinical Testing)
- Chemicals are evaluated for toxicity, pharmacokinetics, and useful biological effects in animals.
- Apply for permission from FDA to test on humans
Clinical Testing (4 phases)
Phase 1 - Tested on volunteers or patients with the condition it is being used to treat. Tests metabolism and biological effects.
Phase 2 - Tested on patients for Therapeutic Utility and Dosage Range
Phase 3 - Tested on patients for Safety and Effectiveness.
(New Drug Application submitted for conditional approval)
Phase 4 - Post Marketing Surveillance. Dependent on Voluntary Reporting by Prescribers.
Testing Procedures
Randomized Trials (RCT) - Most reliable way to quantitatively assess drug therapies.
Use of Controls - Given either placebo or treatment
Randomization - Subjects are randomly assigned to control or experimental group
Blinding - People do not know which group they are assigned.
Single Blind - Only volunteers do not know group
Double Blind - Volunteers and Researchers do not know group.
Limitations of Testing
- Limited Women/Children Research (excluded)
- Limited on Race/Ethnicity (Primarily White Volunteers)
- Limited adverse effect knowledge on drugs due to limitations in patients given drug and short period of time taking said drug.
DEA
Charged with enforcing controlled substance laws, registering companies legally empowered to hold controlled substances, regulating documentation and handling of controlled substances, and fighting drug trafficking.
Controlled Substance Categories
Schedule 1 - No accepted medical use and high risk of abuse (Heroin, LSD)
Schedule 2 - High potential for abuse leading to physical and psychological dependence
Schedule 3 - Moderate to low potential for physical and psychological dependence
Schedule 4 - Low potential for abuse and low risk of dependence
Schedule 5 - Lower chance of risk than 4.
May be dispensed by pharmacist without physician prescription but restrictions on amount, record keeping and other safeguards.
Medication Safety
Most common error is administering wrong dose.
Mitigating Risk of Medication Errors
(QSEN) - Quality and Safety Education for Nurses
(TJC) - The Joint Commission - Releases National Patient Safety Goals
(ISMP) - Institute of Safe Medications Practices - Identifies “High-Alert” Medications that when used in error have heightened risk to harm patient
