Laws/Policies Flashcards
(23 cards)
Form 222
Used to order schedule 1 & 2 controlled substances.
3 copies needed; #1 and #2 go to supplier / #3 keep on file.
Keep for 2 years. Inventoried monthly.
Red Book
Drug pricing
Form 41
Surrendered controlled substances sent to DEA
Medicare A
Covers inpatient hospital stays - 90 days
Form 106
Theft or loss of controlled substances
Kefauver - Harris Amendment
Drug Efficacy Amendment (1962)
Requires proof of effectiveness/safety of drugs before being approved. Side effects & efficacy in advertisements.
USAN
United States Adopted Names - Assigns generic names
FFDCA
Federal Food, Drug & Cosmetic Act (1938)
Requires all products to have list of ingredients, directions & safety warnings.
Durham-Humphrey Amendment
(1951) Distinction between OTC / Prescription Drugs
Poison Prevention Packaging Act
(1970) Child-Resistant Pkg’s
REMS Program
Risk Evaluation and Mitigation Strategies. Helps limit inappropriate dispensing and protects patients.
National Drug Code
NDC Number is a drugs identifier.
10 digits; Labeler (company), drug & pkg size.
USP 795 & 797
Non-sterile & sterile compunding requirements.
Proper PPE for non-sterile compounding.
Gloves, Mask, Apron
Product Code
Info about the formulation of a drug; pkg strength, dosage form & formulation.
MedWatch
FDA’s safety and adverse event reporting system for human drugs, medical devices, vaccines, biologics, dietary supplements & cosmetics.
ISMP
Institute For Safe Medical Practices.
Medication error prevention and safe medication use.
Fail Safes, Standardization, Computerization/Automation
Practices implemented to reduce chances of medication errors. If an error does happen, these will reduce the likelihood of the drug reaching the patient.
Chain of Command
Cashier/Pharmacy Clerk
Pharmacy Technician
Lead Technician
Pharmacist
Pharmacy Supervisor
District Manager
Regional Manager
DEA Registration Number
A number to identify registrant.
Physicians; B, F and G
NP/Physician Assistant; M
Manufacturer/Distributor; P and R
Steps to process a medication order.
Look for patients profile.
Check insurance details.
Identify prescriber.
Identify the medication.
Enter drug quantity.
Interpret directions.
Enter days of supply.
Enter number of refills.
Enter expiration date.
Check script against insurance.
Recalls
Class I - urgent
Class II - moderate danger
Class III - least severe
Compound Documentation Requirements
Products name and amount/strength of each used, including how compound was mixed.
Lot number.
Name all people preparing the compound.
Date of preparation.
Storage requirements.
Beyond-Use dating.
Labeling requirements for all prescriptions.
