Pharm Tech Module 5

National Drug Code (NDC)

a unique and permanent product code assigned to each medication

Legend Medications labeling requirements

• pharmacy name and address

• serial number or prescription number

• date of fill

• expiration date

• prescriber’s name

• patient’s name

• directions for use

• cautionary statements

OTC Product label requirements

• product name

• name and address of manufacturer

• name of distributor

• name of person/place responsible for repackaging

• any other individuals involved in the chain of commerce

• established name of all inactive or active ingredients and the quantities of other ingredients

• net contents

• required cautions and warnings

• name of any potentially habit-forming medication contained in the formula

• adequate directions for use or consumption

Teratogen

an agent that can disturb the development of an embryo or fetus

Risk: Decreased white blood cell count

REMS:

• regular patient lab work

• prescriber and pharmacy registration with REMS to dispense

Risk: Serious risk associate with use

REMS:

• medication guide dispensed with each fill

Risk: Teratogenicity

REMS:

• providing patient education regarding contraception

• negative pregnancy test before each fill

• prescriber and pharmacy registration with REMS to dispense

Risk: Potentially fatal risk of neurological toxicity with use

REMS:

• use of communication plan to providers, caregivers, pharmacists, and the scientific community regarding recognizing symptoms and actions needing to be taken

Risk evaluation and mitigation strategies (REMS)

required risk management plans that use risk-minimization strategies beyond the professional labeling to ensure that the benefits of certain prescription medications outweigh their risks

Elements to assure safe use (ETASU)

required medical interventions or actions health care professionals need to execute prior to prescribing or dispensing a medication to a patient

USP <800>

ensures new standards for handling hazardous materials