Introduction to Pharmacology Lecture (Dr. Segars) Flashcards
Students’ Goal
- Strive to learn key aspects of each drug group and members:
1. Drug Name & Drug Class (MOA vs. Chemical)
- Mechanism of Action
- Indications/Uses
- Toxicities
- ADR/ADE/AE/SE
- Contraindications - Monitoring
- Drug Interactions
Pharmaco- Fields of Study
1) PHARMACODYNAMICS:
- How the DRUG affects the body
a) Mechanism of Action (MOA) – How drugs induce biochemical and physiological effects
2) PHARMACOKINETICS:
- How the BODY affects the drug
a) The time-related physiological process of moving the drug throughout the body
- Common Parameters (ADME):
a) Absorption-Distribution- Metabolism-Elimination
3) PHARMACOGENETICS:
- A field of study of GENETIC IMPACT on drug metabolic or handling processes which can affect individual responses to drugs Therapeutic & Adverse effects
4) PHARMACOECONOMICS:
- A field of study utilizing scientific and economic methods to evaluate and compare value between therapies
- Actual medication COSTS & direct and indirect costs (of using or not using the medication)
5) PHARMACOEPIDEMIOLOGY:
- A field of study that applies epidemiological principles and methods to study the USES and EFFECTS of MEDICATIONS on LARGE POPULATIONS
Pro-Drug
- A drug which resides in an INACTIVE Form (as manufactured) & when administered is transformed (metabolized) into an ACTIVE Compound (capable of inducing pharmacological effect)
Pharmacotherapeutics (Pharmacotherapy or Therapeutics)
- A field of study of the appropriate use of Medications to effectively TREAT OR PREVENT Disease and Manage symptoms
a) Based on Clinically- & Scientifically-sound scientific evidence
i) EVIDENCE-BASED Medicine
Drug Nomenclature
• Names of Medications:
1) CHEMICAL (for chemists only!):
– 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro- 3,7-dimethyl-8-[2-(tetrahydro-4- hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]- 1-naphthalenyl ester, [1S- [1α,3α,7β,8β(2S,4S),-8aβ]]
2) GENERIC name –Simvastatin!!!!!!!!!!!!!!!!!!!
3) TRADE/ BRAND/ MANUFACTURER name – Zocor®
Equivalency Terms
1) PHARMACEUTICAL EQUIVALENCE:
- Same Ingredient(s)
- Same Dosage Form/route
- Same Strength/Concentration
a) and meet the same standards for QUALITY/PURITY
** Ex: Oral Lisinopril (Zestril) 5 mg and Oral Lisinopril (Generic) 5 mg
2) PHARMACEUTICAL ALTERNATIVES:
- Same drug but different salts/complexes, or different dosage forms or strengths:
a) Tetracycline hydrochloride 250mg capsules vs. tetracycline phosphate complex 250mg capsules
b) Quinidine sulfate 200mg tablets vs. quinidine sulfate 200mg capsules
c) Vancomycin 250mg capsules vs. vancomycin 125mg/5ml liquid
3) THERAPEUTIC EQUIVALENCE:
- Must be pharmaceutically-equivalent AND expected to have the same…
1. THERAPEUTIC (clinical) Effect
2. SAFETY Profile
4) BIOEQUIVALENCE:
- Similar rate & extent of ABSORPTION
A) Ex: 80% - 125% of reference product
Equivalency Ratings
Primary FDA Ratings:
1) A:
- Therapeutically-equivalent product & NO
bioequivalence issues
2) B:
- NOT therapeutically-equivalent and/or Significant
bio-equivalence issues
Medications Jurisprudence
Drugs are classified into one of 2 groups:
1) OVER-THE-COUNTER (OTC) / Behind-the-Counter:
- NO prescription required
2) LEGEND (2 categories) Prescription IS required!!!!!!
– Scheduled
– Non-Scheduled
Legend Drugs classified into 2 Groups
1) NON- SCHEDULED/ NON-CONTROLLED:
- NO ABUSE POTENTIAL
a) e.g., furosemide (Lasix) and cephalexin (Keflex)
2) SCHEDULED/ CONTROLLED (C-I thru C-V):
- Based on ABUSE/ADDICTION POTENTIAL
– e.g., fentanyl (C-II)
– C-I agents have no FDA-approved indications
– LOWER RISK of ABUSE the HIGHER the NUMBER
* Group-designation impacts dispense quantity, refills, & prescriptions’ life-span**
9 Legal Requirements for Prescriptions
- Name/Address of PRESCRIBER (usually pre-printed)
- Name/Address of PATIENT
- DATE Prescription was WRITTEN (include year!)
- NAME & STRENGTH of Medication
- DIRECTIONS for USE (acceptable abbrev.’s only)
- QUANTITY to be Dispensed (NUMBER & SPELLING!!!!!!!!!!!)***
- NUMBER of REFILLS allowed (Number & Spelling)
- Prescriber’s SIGNATURE (2 lines to choose from)
- Prescriber’s DEA NUMBER
- The DEA # - a 2-letter & 7-digit number to personally identify physician (checked by RPh) [e.g., AB1234567]
– Required by law if the medication is scheduled /controlled!!!!!!!!!!!!
– Required by some payers, regardless of Schedule/Control STATUS!!!!!!!!!!
Non-Controlled Legend Prescription
A) Life-span = 12 mo.’s OR # of refills (whichever occurs first)
- NO legal LIMIT on # of REFILLS or quantity dispensed during 12 month life span (limits set by insurance)
B) PARTIAL FILLING – possible until full quantity of prescription and ALL Refills Dispensed or Expiration date (1 yr)
C) Office staff acting as “AGENT” for Refills or transmission or Rx/order
- Physician signature ALWAYS on WRITTEN Rx’s!
Controlled/ Scheduled Legend Prescriptions
A) Life-span=6 mo.’s OR # of refills (whichever occurs first)
1) There is a LEGAL LIMIT on NUMBER of REFILLS:
– For C-III through C-V = 5 refills
– For C-II* = None (0 refills)
2) There is a LEGAL LIMIT on
QUANTITY DISPENSED
– 90 days for C-III through C-V
– 30 days for C-II
B) PARTIAL FILLING:
– Possible only for C-III/IV/V until full quantity of prescription and all refills dispensed or expiration (1 yr)
C) PARTIAL FILLING NOT POSSIBLE for C-II, unless:
1) Pharmacist doesn’t have full quantity (72 hours),
or
2) Long-term care/Hospice
D) OFFICE STAFF acting as “AGENT” for refills or transmission or Rx/order–except C-II!
- Physician SIGNATURE ALWAYS on written Rx’s!!!!!!!
Oral/ Faxed/ Electronic Prescirptions
A) Physicians or their “agent” can call in or transmit electronically to provide REFILLS or to SUBMIT (fax) original PRESCRIPTIONS for all Legend drugs, EXCEPT for C-II
- C-II only called in by physician during an “EMERGENCY”
a) When physical-Rx can’t be written/delivered based on the clinical situation
B) Prescriptions for ALL* Legend drugs can be Faxed or Electronically-submitted
- Secure-scanned or Program (exceptions for C-II)
“Emergency” defined for Controlled Agent
A) IMMEDIATE Administration is necessary for proper treatment of the intended ultimate user, or
B) NO APPROPRIATE (alternative) Treatment is AVAILABLE, INCLUDING administration of a drug which is NOT a C-II substance, or
C) It is NOT REASONABLY POSSIBLE for prescriber to provide Written Prescription to the pharmacist Prior to dispensing
- 72 hours ALLOWED for delivery of Rx to dispensing pharmacy
- QUANTITY LIMITED to amount NEEDED during emergency
Collaborative Practice Contracts
A) RPh/NP/PA/etc…
- Can write for a non-scheduled, legend drug if documented in
a signed collaborative practice agreement/contract
- 9 Legal Requirements of Rx – Need name & contact information of physician AND personnel writing prescription
B) CANT RETURN dispensed medications
- Medication Turn-In events/Proper disposal
C) Medication SAFETY & SECURITY
D) Pharmacists carry LIABILITY also
