Review Flashcards
Products containing PSE and EPH must be packaged in blister packs with each blister containing not more than _______ dosage units or in unit dose packets not containing more than _______ mg of PSE or EPH
2 dosage units
3000 mg
CS scheduling is automatically made uniform with fed law how many days after fed scheduling
30 days
unless DHS objects and hearing is held to place in different schedule
record keeping for PSE/EPH
Name and address of purchaser date and time brand product name quantity of PSE/EPH
witness to dispose Cs
licensed physician pharmacist mid level practitioner nurse a state or local law enforcement officer or other auth person
dea form 41
submit 3 copies of that form to agent in charge in area
prepared in quadruplicate
copies must be sent to local DEA diversion office after the destruction
can request help
True or False. Prior DEA authorization to destroy controlled substances is not necessary when an authorized member of a state law enforcement authority or regulatory agency witnesses the destruction.
TRUE!!!!
Illinois law
Notification of theft or loss to dea within _____ business days
1 business day of discovery
by phone, fax or written message
notify who of theft or losss
DEA, local police
form used when theft or loss of CS’ and who to send it to
DEA form 106
send to DEA, IDPR
send copy to both!!!
DEA form 106 must include:
Name and address of firm (pharmacy)
DEA reg. #
Date of theft
Name and # of local police notified
Type of theft (robber, night break in etc)
Listing of symbols or cost code used by pharmacy in marking containers if any
Listing of CS’ missing from theft or sig. loss
If not theft or loss found what to do
notify DEA in writing why there is no form 106 being filled out
what happened?
who shall have access to LTCF emergency kit
Director of nursing, RN on duty, Licensed practical nurse on duty, consultant pharmacist or consultant physician
maintenance treatment vs detox treatment
< 21 days = detox (narcotic drug -free state is goal)
> 21 days = maintenance (heroin,morphine like drug)
True or False. When a person is on methadone for detox, no methadone can be prescribed for analgesic purposes.
True!!!!!!!!!!
Waived the requirement for a separate DEA registration as a opiod treatment program for practitioners who dispense or prescribe FDA approved schedules III-V narcotic controlled substances for use in maintenance or detoxification treatment. allows office-based setting addiction treatment
Buprenorphine drugs allowed (suboxone, subutex)
DEA # and DEA waiver # starting with an X
LTCF shall transmit patient medication profiles to PMP monthly
n
is it MISBRANDING OR ADULTERATION if:
the dosage, frequency, duration or route of administration suggested in the labeling is DANGEROUS
MISBRANDING
true or false. misbranding occurs when a pharmacist dispenses without an RX or authorized refill
TRUE!!!!
misbranding can apply to pharmacist too!!! how
pharmacist dispenses drug w/o rx or auth refill
pharm misfills an rx (technically no rx for that drug)
labeling includes
package insert
drug advertisements
info in publication as PDR
promotional materials, including newsletters and literature used in promotion
what kind of recall if may cause temporary or medically reversible adverse health consequence
Class II recall
Not likely to cause serious adverse health consequences
class III recall
can cause serious adverse health consequences or death
Class I recall
Step 1
in vivo ANIMAL STUDIES
STEP 2
IND
STEP 3
CLINICAL TRIALS
PHASE 1
PHASE 2
PHASE 3
PHASE 1
SMALL HEALTHY GROUP;
TOXICOLOGY
PK
SAFETY
PHASE 2
LARGER GROUP (100) WITH DISEASE OR SYMPTOMS
EFFECTIVENESS
DOSING
SAFETY
ADVERSE EFFECTS
PHASE 3
LARGE GROUPS IN DIFFERENT GEOGRAPHICAL LOCATIONS (CONTROLLED CLINICAL TRIALS)
DRUG EFFECTIVENESS COMPARED TO PLACEBO DOUBLE BLINDED (MOSTLY)
STEP 4
NDA
PHASE 4 STUDIES
POST MARKET SURVEILLANCE
SAFETY
EFFECTIVENESS
SUBMIT TO FDA YEARLY
MFG TO REPORT ADVERSE EFFECTS MANDATORY!!!!!!
ipecac syrup
1 fluid ounce without RX
‘FOR EMERGENCY USE TO CAUSE VOMITING IN POISONING. BEFORE USING, CALL PHYSICIAN, THE POSING CONTROL CENTER OR HOSPITAL IMMEDIATELY FOR ADVICE
***DOSE 1 TABLESPOON IN PERSONS OVER 1 YEAR OF AGE
EFFERVESCENT PREPARATIONS AND PREPARATIONS CONTAINING PARA-AMINOSALICYLATE AS THE ONLY SALICYLATE INGREDIENT ARE EXEMPTED FROM THE REQUIREMENT OF LABELING “KEEP OUT OF REACH OF CHILDREN (HIGHTLIGHTED IN BOLD) IN CASE OF OVERDOSAGE GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY
TRUE
CANNOT PRESCRIBE IN ILLINOIS
CHIROPRACTORS NAPRAPATHS PHYSICAL THERAPISTS OCCUPATIONAL THERAPISTS REGISTERED NURSES LICENSED PRACTICAL NURSE PSYCHOLOGISTS PHARMACISTS
WHAT CIIS CAN BE DELEGATED BY PRACTIONER TO MID LEVEL
ORAL TOPICAL OR TRANDERMAL
** NO INJECTION OR OTHER ROUTES!!!!!!
PHYSICIAN ASSISTANT must discuss the condition of patients for whom a controlled substances is prescribed monthly
monthly
how many hours for physician assistant prescribing rights
45 hours in pharmacology (for C-II)
5 hours of continuing education in pharmacology (ANNUALLY)
PHYSICIANS ASSISTANT
ADVANCED NURSE PRACTITIONER
PA = SUPERVISION ANP = COLLABORATIVE
RX REQUIREMENTS WHEN ANP OR PA
must have delegating practitioners name
dea # (if CS) and signature of MID - LEVEL practitioner
optometrist can prescribe what CS? and how much
CIII-CV ((**no CII**)
only up to 72 hour supply
board of pharmacy
9 members: • 7 pharmacists (must ≥5 years experience, licensed bs or pharmd) • 2 non-pharmacist public members appointed by governer 5 year terms max 12 year consecutive years meet quarterly
pharmacy coordinator and investigators
1 chief
2 deputies
appointed by DPR director
cannot be member of board
registered pharmacist
≥ 5 year experience immediately prior to appointment
must be at least 4 pharmacy invesitgators
true
