Part G - Food & Drugs Act (Controlled Drugs) Flashcards
Part G of the FDA encompasses what class of drugs?
Controlled Drugs
Define what a “preparation” is (as outlined by G.01.001 of the FDA).
a drug product containing a controlled drug & one or more active medicinal ingredients (in a recognized dose other than a controlled drug)
Define what a “prescription” is.
authorization given by practitioner that stated amt. of a controlled drug be dispensed for the person or animal named
Who can possess a controlled drug [G.01.005 (1)]?
-Those who require it for their business or profession
-Hospital employee or practitioner in a hospital
-Obtained controlled drug for their own use
-Practitioner of Medicine
Only people who are able to produce / assemble / sell / provide / transport / send / deliver / export / import controlled drugs [G.02.001]?
Licensed Dealers
Who can Licensed Dealers sell to?
1) Other Licensed Dealers
2) Pharmacists (except those named in notices)
3) Hospital Employees (but MUST be either Practitioner or Pharmacist within that hospital)
What components of a written order are needed in order for a Licensed Dealer to sell or provide controlled drugs?
-Pt. I / II / III controlled drug
-Name & Qty. of controlled drug
-Signed & Dated (with signature verified)
What components of a verbal order are needed in order for a Licensed Dealer to sell or provide controlled drugs?
-Pt. II / III controlled drug
-Name & Qty. of controlled drug
-Receipt within 5 business days (Sig. of Pharmacist or Practitioner who received drug, date, name & qty. of controlled drug)
Licensed Dealers must record what information when conducting a general sale?
-Name of Drug / Form / DIN / Qty. / Strength
-# per package & # of total packages
-Name & Address of who it was sold to (& dated)
Licensed Dealers must record what information when conducting a Verbal Order?
-Name of person placing order
-Date order was received
-Name of person recording the order
Which division within Part G of the FDA targets us as Pharmacists?
Division 3 [G.03]
What must Pharmacists keep on file once a controlled drug has been received [G.03.001]?
-Name & Qty. of controlled drug received
-Name & Address of person who sold or provided
-Date it was received
In order to sell or provide controlled drugs to a person, a Pharmacist requires what from a written prescription?
-Signature of Prescriber & must be Dated (!!).
In order to sell or provide controlled drugs to a person, a Pharmacist requires what from a verbal prescription?
-Ensure that the person they’re speaking to is the Prescriber.
Pharmacists who sell or provide controlled drugs to Practitioners are required to keep a separate Narcotic / Controlled Drug File… What must be on this file?
-Name / Address of Practitioner & Date when drugs were provided
-Name & Qty. of controlled drug sold
Pharmacists supplying hospital employees (ie. Other Pharmacists or Practitioners) with controlled drugs can only do so after the receipt of what?
-Written (NO VERBALS!!!), signed, dated & verified order.
What is required in order for a Pharmacist to refill a prescription for a controlled drug?
-Refills listed on Rx
-Intervals between refills
-Pt. I drugs must be written
-Pt. II or III can be written or verbal
-Records of each refill
Upon dispensing a drug from Pt. I of the schedule, what must a Pharmacist do?
-Record their name or initials
-Practitioner’s name, initials & address
-Pt. name & address
-Name / qty. / dosage form of drug
-Date dispensed
-Number assigned to order or Rx
Verbals taken for controlled drug prescriptions must be reduced to writing & must contain what information?
-Pharmacist name or initials
-Practitioner name / initials / address
-Pt. name & address
-Name / qty. / dosage form of drug
-Directions
-Date dispensed (& date received)
-Rx number
Pharmacist Managers are required to retain all controlled drug prescriptions for what length of time?
At least two years
In accordance with G.03.012, the SCPP recently mandated what protective measure to prevent narcotic thefts?
Time-Delayed Safes
G.03.013 requires that all narcotic losses / thefts be reported within how many days of discovery?
Within 10d of discovery (NOT NECESSARILY WITHIN 10d OF OCCURRENCE).
G.03.014 permits Pharmacists to do what (returns & emerg stuff)?
-Return CD’s to Licensed Dealers
-Provide emerg. supplies to another Pharmacist
-Sell or provide to Minister
-Provide CD’s to authorized officials
G.04.001 (3) outlines Practitioner administration rules… What human / animal conditions being treated allow for administration of a designated drug?
Humans: Narcolepsy, HK Disorders (kids), Epilepsy, Parkinsonism, Hypotensive States assoc. with Anesthesia.
Animals: Depression of Cardiac & Respiratory Centers.
G.04.001 (4) outlines what “Designated Drugs” are… What are they?
-Amphetamines
-Benzamphetamine
-Methamphetamine
-Phenmetrazine
-Phendimetrazine
AND THEIR ASSOC. SALTS!!!
G.05.003 (1-5) permits a hospital to provide all categories of CD’s to whom?
1-2) In / Out-Pt.’s upon written order of a Practitioner.
3) Emerg. supplies to Hospital Employee or Practitioner in a different hospital.
4) To a Pharmacist.
5) To a researcher of the hospital.
G.06.004 states that CD’s can’t be what?
Advertised to the general public… Pkg. must also contain “C” in a diamond!
Pt. 1 - Level 1 Controlled Drugs… What are they?
-Amphetamines
-Methylphenidate
-Phendimetrazine
-Phenmetrazine
-Pentobarbital
-Secobarbital
Pt. 2 - Level 2 Controlled Drugs… What are they?
-Barbiturates (except LV. 1 Barbs)
-Thiobarbiturates
-Thiopental
-Chlorphentermine
-Diethylpropion
-Phentermine
-Butorphanol
-Nalbuphine
Pt. 3 - Level 3 Controlled Drugs… What are they?
-Anabolic Steroids
Are Pharmacists allowed to possess Restricted Drugs (Part J of FDR)?
NO!!!!
-Includes Amphetamines & LSD (Pt. I), Salvia Divinorum (Pt. II).
