Prelim | Drug Classification (Legal Purchase) Flashcards
”Food, Drug, and Cosmetic Act”
RA No. 3720
RA No. 3720
”Food, Drug, and Cosmetic Act”
Drug Classification according to Legal Purchase
Non-Prescription / OTC
Prescription / Legend Drugs
”Food, Drug, and Cosmetic Act” determines characteristic of the drug that we purchase according to:
- Efficacy
- Purity
- Potency
- Safety and toxicity
Effectiveness of drug
Efficacy
Efficacy is synonymous with what FDA requirement?
Indications
Most important composition/ substance must be present in high content
Purity
Purity is synonymous with what FDA requirement?
Chemical composition
How much harm the product can produce
Safety and toxicity
Potency is synonymous with what FDA requirement?
Chemical strength
Safety & toxicity is synonymous with what FDA requirement?
Contraindication and reported side effect
Available for purchase without a prescription and can be purchased right off the shelves at a store - without a visit to a prescriber (physician) or consultation with a pharmacist
Non/ Prescription / OTC
A written order by a registered physician directing the pharmacist to prepare or dispense pharmacological agents for diagnosis, prevention or treatment of a disease.
Prescription/ Legend Drugs
4 COMPONENTS OF PRESCRIPTION:
- Superscription
- Inscription
- Subscription
- Signature
Rx is latin for (1) which means (2)
- recipe
- to take
“Rx” may be found in what component of prescriptions
Can be found in supersciption and/or insciptions
Body of the presctiption
Inscription
Component of prescription that includes name of medication
Inscription
Component of prescription that includes amoint/ strength of dose to be disposed
Inscription
Component of prescription that includes instruction to the pharmacist (including no. of tablets to dispense)
Subscription
Refers to instruction to the pt
“sig” = sigma
Component of prescription that includes physician’s identification such as name, signature, and DEA numbre
Signature
ELEMENTS OF PRESCRIPTION
A. PRESCRIBER RELATED
B. PATIENT RELATED
C. BODY OF PRESCRIPTION
D. OTHERS
E. PRESCRIBER’S IDENTIFICATION
PRESCRIBER RELATED ELEMENTS OF PRESCRIPTION
- Name
- License Classification
- Address
- Contact num
- Date
PATIENT RELATED ELEMENTS OF PRESCRIPTION
- Name
- Gender/Age/ DOB
- Address
BODY OF PRESCRIPTION ELEMENTS OF PRESCRIPTION
- Medication name (usually generic)
- Medication strength
- Dispensing quality and dosage
- Direction for use
“OTHERS” ELEMENTS OF PRESCRIPTION
- Refill Information
- Additional
Warnings
PRESCRIBER’S IDENTIFICATION ELEMENTS OF PRESCRIPTION
- Prescriber’s name
- Prescriber’s signature
- Prescriber’s registration
number (DEA: Drug Enforcement Administration #)