2.1
How do you dispose of hazardous Drugs
Place trace wastes in yellow chemotherapy bags to be disposed at a medical waste facility
what are the schedules for controlled drugs
Schedule I — drugs with a high abuse risk. These drugs have NO safe, accepted medical use in the United States
Schedule II — drugs with a high abuse risk, but also have safe and accepted medical uses in the United States. These drugs can cause severe psychological or physical dependence. Schedule II drugs include certain narcotics, stimulants, and depressant drugs.
Schedule III, IV, or V — drugs with an abuse risk less than Schedule II. These drugs also have safe and accepted medical uses in the United States.
Schedule III, IV, or V drugs include those containing smaller amounts of certain narcotic and non-narcotic drugs, anti-anxiety drugs, tranquilizers, sedatives, stimulants, and non-narcotic analgesics
Which form is required to dispense controlled substances?
Form 222
Can a pharmacy technician fill controlled substances?
Pharmacy technicians may play a role in the ordering of controlled substances. Schedule I and II medications may be ordered by filling out a DEA Form-222 or electronically via the DEA Controlled Substance Ordering System (CSOS).
what did the combat meth act of 2005 do
regulates, among other things, retail over-the-counter sales of EPH, PSE, and PPA products which are common ingredients found in cold and allergy products
what is Non-Hazardous Pharmaceutical Waste
This type of pharmaceutical waste is what you'll find over-the-counter; acetaminophen, ibuprofen, naproxen, and combination cold medications, contraceptives, all classes of antibiotics, hormones, and non-RCRA prescription medications
what must be in a prescription for a controlled drug
Issue date.
Name and address of patient.
Name, address, and DEA registration number of practitioner.
Drug name.
Strength of drug.
Dosage form (eg, tablet, suspension)
Quantity prescribed.
Directions for use.
What form is needed to destroy controlled substances?
form 41
what is a Restricted Drug Program
Lists medications with special dispensing requirements. These drugs generally are very useful for a small population or have a unique role in health care. They also may have some very serious drawbacks to their use.
Max amount of Pseudoephedrine you can buy,
3.6 grams per day and 9 grams in a 30-day period.
Handling of pharmaceutical substance
Bags containing materials contaminated with hazardous drugs must be labeled appropriately
Waste should be not be moved from one area to another
The bag should be sealed when filled and covered waste container
What is the refilling date for a controlled substance?
No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued.
How long should the Controlled Substances Inventory log be kept?
What is a Risk Evaluation and Mitigation Strategy (REMS)?
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risk
The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
what are RCRA Hazardous Pharmaceuticals
waste that exhibits a characteristic of hazardous waste such as (ignitability, corrosivity, ractivity, or toxicity)
How many times can schedules C III C IV and CV prescriptions be transferred?
When a controlled substance is stolen or lost from a pharmacy the nearest DEA office must be notified using which DEA form?
Form 106
what is an ETASU
An Element to Assure Safe Use (ETASU) is considered the most extensive component of a REMS program and involves specific actions that healthcare professionals must execute prior to prescribing, dispensing, or continuing the drug. Of close to 80 approved REMS as of July 2016, 43 incorporate an ETASU.
What are the Types of FDA Recalls
Market withdraw:a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.
Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
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What is the maximum number of refills permitted for a Schedule III medication?
Five Times
REMS requirements/what is in a REMS
REMS include a risk mitigation goal, and are comprised of information communicated to and/or required activities to be undertaken by one or more participants (e.g., health care providers, pharmacists, patients) who prescribe, dispense or take the medication
What is Medwatch
FDA's medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as: Prescription and over-the-counter medicines.