Competency 14

Florida Right To Know Law

Employers obligation to:
Inform employees of toxic substance in the workplace.
Provide them with training.
Provide them with information.
Provide them with emergency procedures.

D.E.A

Drug Enforcement Administration: A federal agency that administers and enforce federal laws for controlled substances

biennial inventory

all controlled substances on hand upon commencing operations or upon change in ownership, with subsequent inventories conducted every two years thereafter

Food and Drug Act

Outlaws states from buying and selling food, drinks, and drugs that have been mislabeled and tainted

FDA

Food and Drug Administration

Federal Food, Drug, and Cosmetic Act

Requires new drugs to be proven safe prior to marketing;
Starts a new system of drug regulation;
Requires safe limits for unavoidable poisonous substances;
Allows for factory inspections

Durham-Humphrey Amendment

Defines the type of drugs that cant be used safely without medical supervision and limits the sale to prescription only by medical professionals

Kefauver-Harris Drug Amendments

Requires manufacturers to prove that their drugs are effective prior to marketing

Over-the-counter Drug Review

Nonprescription medications must be safe, effective, and appropriately labeled

Tamper-Resistant Packaging Regulations

Makes it a crime to tamper with packaged products and requires tamper-proof packaging

Drug Price Competition and Patent Term Restoration Act

Allowed FDA to approve generic versions of brand-name drugs without repeating research to prove safety and efficacy, allowed brand-name drugs to apply for up to 5 years of additional patent protection for new drugs to make up for time lost while their pro

Food and Drug Administration Modernization Act

Expands scope of agency activities and moves agency to the Department of Health and Human Services

Categories of Pharmacy Licenses

Nuclear
Mail Order
Sterile-compounding pharmacies
Retail
Community
Hospital

DEA Form 222

Used for ordering Schedule II controlled substances

Schedule I

Most restrictive
High potential for abuse
Not available in pharmacy
(Heroin and Marijuana)

Schedule II

High potential for abuse and misuse
high risk of dependence
(Oxycodone, Ritalin, Morphine, Hydrocodone)

Schedule III

Moderate potential for abuse, misuse and dependency
Includes combo drug products
(ex. Tylenol w/ codeine)

Schedule IV

Low potential for abuse and limited risk of dependency
(Valium, Ativan)

Schedule V

Lower potential for abuse, misuse, or dependence
(Cough meds, anti-diarrheal meds, Lomotil)

Dispensing Controlled Meds

Date issued
Patients full name and address
Doctors name, address, DEA #
Drug name,strength, dosage form, quantity
Directions for use
Number of Refills
Prescriber signature

Refills of Controlled Drugs:
Schedule II and IV
Schedule V
Schedule II

-Up to 5 times within 6 months
-May be refilled more than 5 times, 6 month time limit
-May not be refilled

Ephedrine and pseudoephedrine

Cold meds, allergies
3.6 grams/day
9 grams/30 day period

HIPAA

Health Insurance Portability and Accountability Act

NDA

New Drug Application

DAW

Dispense as written

DNS

Do not substitute

NABP

National Association of Boards of Pharmacy

OTC

Over the counter

CMEA

The Combat Methamphetamine Epidemic Act

PPI

Patient Package Insert

PHI

Protected Health Information

NACDS

National Association of Chain Drug Stores

Poison Prevention Packaging Act
child-resistant packaging

80% of children from opening the package but allow 90% of adults to open the containers without difficulty

Prescribing Errors

Occurs at the time a prescriber orders a drug for a specific patient. (incorrect drug, dose, dosage form, route of administration, length of therapy, number of doses)

Omission Errors

Failure to administer an ordered dose to a patient in a hospital, long-term care facility, other facility before the next scheduled dose

Wrong Time Errors

Administering doses too early or too late can affect the drug blood level and consequently the efficacy of the drug. Med window is 30 minutes before or after scheduled time

Unauthorized Drug Errors

Occurs if medication for one patient was given mistakenly to another patient or if a nurse gave a medication without a prescriber order. (when patients share prescriptions at home)

Improper Dose Errors

Occur when a patient is given a dose that is greater or less than the prescribed dose

Wrong dosage form Errors

Doses administered or dispensed in a different form than ordered by the prescriber

Wrong drug preparation Errors

reconstituting, diluting medications wrong

Wrong administration technique Errors

Doses administered using an inappropriate procedure or incorrect technique

Deteriorated drug Errors

Drugs used past expiration dates, loses potency, from improper storage

Monitoring Errors

Results from inadequate drug therapy review.

Compliance Errors

Committed by patients when they fail to follow or adhere to a prescribed drug regimen.