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Food, Drug, and Cosmetic Act (FDCA) of 1938
Established the FDA; drugs must be safe and labeled accurately.
Controlled Substances Act (CSA) of 1970
Created DEA schedules I–V for drugs with abuse potential.
Drug Enforcement Administration (DEA)
Regulates controlled substances and issues DEA numbers.
Poison Prevention Packaging Act (PPPA) of 1970
Child-resistant packaging required for most prescription medications.
Health Insurance Portability and Accountability Act (HIPAA) of 1996
Established patient privacy and confidentiality regulations.
Omnibus Budget Reconciliation Act (OBRA) of 1990
Requires counseling for Medicaid patients.
Combat Methamphetamine Epidemic Act of 2005
Limits sales of pseudoephedrine and logbook requirements.
Schedule I (C-I)
No accepted medical use; examples include heroin and LSD.
Schedule II (C-II)
High abuse potential with no refills; includes morphine and oxycodone.
Schedule III (C-III)
Moderate abuse potential; includes Tylenol with codeine.
Schedule IV (C-IV)
Low abuse potential; includes alprazolam and diazepam.
Schedule V (C-V)
Lowest abuse potential; includes cough preparations with codeine.
Prescription requirements
Includes patient name, address, date, drug name, dosage form, quantity, directions, prescriber’s name, signature, DEA #.
State vs. Federal laws in pharmacy
Always follow the stricter law.
Refill rules for controlled substances
C-II = no refills; C-III to V = up to 5 refills in 6 months.
Recordkeeping requirement
Minimum of 2 years, often 3–5 years by state.
Converting units in pharmacy
1 tsp = 5 mL, 1 tbsp = 15 mL, 1 oz = 30 mL, 1 kg = 2.2 lbs.
Days' supply calculation
(Quantity dispensed) ÷ (Daily dose).
IV flow rates calculation
(Volume (mL) × Drop factor (gtt/mL)) ÷ Time (min).
Common Analgesics - Opioids
Examples include oxycodone (OxyContin), hydrocodone/acetaminophen (Norco), morphine.
Common Analgesics - NSAIDs
Examples include ibuprofen (Advil) and naproxen (Aleve).
Common Antibiotics
Examples include amoxicillin (Amoxil), azithromycin (Zithromax), ciprofloxacin (Cipro).
Common Antihypertensives
Examples include lisinopril (Prinivil, Zestril), amlodipine (Norvasc), metoprolol (Lopressor), losartan (Cozaar).
Common Antidiabetics
Examples include metformin (Glucophage) and insulin glargine (Lantus).
Common Antidepressants
Examples include sertraline (Zoloft), fluoxetine (Prozac), escitalopram (Lexapro).
Common Statins (Cholesterol)
Examples include atorvastatin (Lipitor) and simvastatin (Zocor).
Common Anticonvulsants
Examples include gabapentin (Neurontin) and levetiracetam (Keppra).
Common Proton Pump Inhibitors (PPIs)
Examples include omeprazole (Prilosec) and pantoprazole (Protonix).
Common Asthma/COPD medications
Examples include albuterol (ProAir, Ventolin) and fluticasone/salmeterol (Advair).
Common Anticoagulants
Examples include warfarin (Coumadin) and apixaban (Eliquis).
Pharmacy Operations
Includes prescription processing steps, labeling requirements, inventory control, handling recalls, medication storage, patient safety.
Medication Safety Practices
Includes error prevention strategies like barcoding and double checks.
High-alert medications
Medications that require special attention, including insulin, anticoagulants, and opioids.
Compounding pharmacy processes
Includes non-sterile and sterile preparations, adhering to guidelines like USP
Insurance and Billing terms
Common terms include copay, coinsurance, deductible, and prior authorization.
Third-party processing elements
Includes BIN, PCN, Group #.
Medicare/Medicaid Prescription Benefits
Part D covers prescription benefits.
Common Pharmacy Abbreviations - Sig codes
Examples include po (by mouth), qd (once daily), bid (twice daily), tid (three times daily), prn (as needed).
Study tips for pharmacy students
Memorize Top 200 drugs, know DEA schedules, practice calculations, review side effects.