Hazardous materials(sterile. non-sterile compounding)
- externally vented through HEPA filter
- physically separated
- negative
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Hazardous drug examples
- carcinogenic
- teratogenic
- reproductive toxicity
- genotoxicity
- drugs that mimic existing hazardous drugs in structure or toxicity
Theft(DEA form, procedure)
- DEA form 106(document amount stolen)
- original and one copy sent to DEA, pharmacy keeps one copy
- Notify DEA regional office and division of drug control(and police)
Where to store controlled substances
- Either in locked cabinet or dispersed throughout pharmacy
Destruction of CS(DEA form)
DEA form 41
- list all drugs to be destroyed
- witnesses(physician, pharmacist, midlevel practicioner, nurse or law enforcement)
- 2 signed copies for DEA form 41
- keep perpetual inventory of controls awaiting destruction
Initial and biennial inventory
- how long are records kept?
Inventory must be taken any time drug reclassified(non-CS to CS)
- Records kept for 2 yrs
- CII exact count(accept manufacturer's seal)
- CIII-CV, approximate(exact count if >1000 pills)
DEA form to sell or buy CI or CII?
DEA form 222
How long should order forms be maintained?
2 years
Substituting quantities?
Yes if it's the same quantity (1x500 or 500x1)
Rules with regards to CI?
Can only be ordered by researchers
Rules with regards to selling CII?
Cannot sell more than 5% of annual purchases without registering as a distributor
Rx for office use?
Never, cannot accept Rx for office use or medical bag
DEA number letters - profession
FAB - prescribers
M - Midlevel practitioners
DEA number algorithm
+ Add digits 1, 3, 5
+ Add digits 2, 4, 6 and double the sum
+ last digit of sums should match 7th digit
Is a DEA number required in any location where there are controlled substances
Yes
- eg each location of a retail chain pharmacy
eg manufac., distrib., wholesaler, dispenser, researcher, exporter
Do employees need a DEA number if the hospital has one?
No
DEA number if pharmacy closes
Must notify DEA
DEA registration renewal
Pharmacies?
MDs? Manufacturers?
Pharmacy - 3 years
MDs - 3 years
Manufacturers & distributers - 1 year
Schedule II physical or psychological dependence
+ examples
High-High
Endocet, Desoxyn(methamphetamine), Actiq(Fentanyl), Cocaine, Aptensio(methylphenydate)
Schedule III
Physical and psychological + examples
Moderate, Low - High
Dronabinol(Marinol, syndros)
Drug Recall Class I
Return?
- Drug causes serious adverse events including death
- notify patients
- mandatory return of inventory
Drug Recall Class II
-temporary or reversible adverse effects
- inventory should be returned
- patients do not need to return drugs
Drug Recall Class III
- No adverse effects
- manufacturer only
Veterinary drugs
Rx or OTC?
Can be both
Can a veterinarian prescribe human drugs for animals?
Yes
OBRA 90
Guidelines that states need to follow to be reimbursed by federal government for medicaid services
Counseling requirements
OBRA 90
MUST offer to counsel in a way that encourages patient
must document refusal
OTC GERD meds
H2 blockers
Famotidine(Pepcid) max 20mg (Acid is nizatidine btw)
Cimetidine(Tagamet) > 200mg
Ranitidine(Zantac) > 150mg
OTC GERD meds
Antacids
ALka-seltzer, gelusil, maalox, mylanta, pepto-bismol, rolaids, tums
OTC GERD meds
PPI
omeprazole(Prilosec) > 20mg
Lansoprazole (Prevacid) > 15mg
Compound drugs requirements
- Do not compound drugs withdrawn from market
- Must show comparable REMS control if REMS drug
- must contain all necessary information(eg. office use, this is a compounded drug)
Outsourcing facilities
must obtain wholesale distributor permit
not required to be a licensed pharmacy but must be supervised by one
Non-sterile compounding simple
reconstitution, BUDs
Non-sterile compounding moderate
special calculations
Non-sterile compounding
complex
special training, environment, facilities, equipment
Must sterile and non-sterile compound areas be separated?
Yes
Non-sterile compounding liquid?
Water (H2O)
Labeling compounding requirements
- generic or chemical name
- strength or quantity
- pharmacy lot number
- beyond-use date
- any special storage requirements
Compounding BUD
non-aqueous
6 months or earliest expiration date of any API
Compound BUD
aqueous oral
14 days
Compound BUD
aqueous topical
30 days
Max daily and monthly dose sudafed et al.
+ identification
3.6g/day
9g/month
(7500mg from mail order pharmacy)
state DL or state issued ID or passport
keep logbook for at least 2 years
Methadone(Dolofine) dispensing
For pain only
not for opioid addiction
40mg dose is only available at methadone clinic not in retail pharmacy
Pharmacist- power of attorney for?
only for filling DEA form 222
must keep record for 2 years
Drug Bioequivalence
Orange book
USP / DI
Poison Prevention Package
NO more than 20% kids can open, less than 10% of adults should be unable to open
HCFA jurisdiction?
HHS
DEA can only audit?
invoices of controlled substances
prescription files
Special label warning for these adjuvants
sulfites
aspartame
Drug can be purchased without DEA form
Marinol
phenobarbital
How many therapeutic categories?
208
Proposed FDA regulations published where?
Federal register
Pharmacist convicted of criminal possesion of illegal drugs
Inform employer within 5 days
Packages insert(no AWP)
Contraindications
symtoms and treatment of overdosing
adverse reactions
date of most recent revision
Listing ingredients on product label(separation)
additive separated from active ingredients
Faxing CIIs ok if?
LTCF(nursing homes, nursing facilities)
Home infusion pharmacies for parenteral administration
Hospice
Oral CIIs>
ONly in case of emergency
must receive written RX within 7 days
otherwise notify DEA and Department of Hygiene and Mental Health
Who determines drug schedule
US Attorney General
Bar coding pharmaceutical products
Hospitals
Drugs in child-resistant package
PLAIN MAD
Prescription drugs
Lidocaine, Loperamide
Aspirin
Ibuprofen
Naproxen, non-prescription
Methyl salicylate
Acetaminophen
Diphenydramine
Ineligible drugs for repository program
Controlled substances
drugs that require refrigeration
compounded drugs
drugs that expire within 90 days
adulterated drugs
Locations which could have samples
Hospital pharmacy
Physician's office
Sale of schedule V codeine
Not more than 120ml or 24 dosage units within 48 hours
Required on labels of pharmaceutical products
coloring agents
antimicrobial preservatives
NOT FLAVORING AGENTS
Maximum ipecac syrup sold qty
30ml
only required to have its warnings printed in red ink
Home-use sterile drug products classification system
low risk versus high risk
Labeling requirements Schedule II to V
Required:
pharmacy name and address
date of filling and date of prescription(?)
serial number
name of prescriber
Name of patient
name and strength of drug
Directions for use
expiration date
Cautionary statement(EXCEPT SCHEDULE V)
Prescription requirements CSA
date and signed on date of issuance
name and address of patient
drug name, strength, dosage form, quantity
name, address, DEA of prescriber(exempt are prescribers in the public service)
Informed consent drug
olanzapine
Isotretinoin
Controlled substances inventory
Can have a tech help to count
can use recording device
CANNOT store records on recording device
Protocol for hospital to have samples
store samples separate from regular stock
licensed practitioner must have requested them
Medicare patient enroll time
have 7 months
Ephedra cannot be in?
Dietary supplements
Parenteral product not required to list?
inert gas [Show Less]