Reading...
Play button
Play button
Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
197 Cards in this Set
- Front
- Back
|
Controlled Substances Act of 1970
|
gave FDA authority to determine scheduling of CS's
preventing drug abuse approach |
|
|
Creation of DEA by DOJ-1973
|
removed scheduling responsibility from FDA
provided DEA with following functions associated with CSA -interpretation -implementation -enforcement -regulation |
|
|
Access of CS's are restricted through __ and ___.
|
registration and scheduling
|
|
|
A single pharmacy could be required to have multiple DEA numbers, depending on its ______.
|
activities
|
|
|
When do employees of registered pharmacies need to register independent of the pharmacy?
|
RPh has prescribing ability
|
|
|
Pharmacy Registration-
Generally, pharmacies register as a ______. What about hospital pharmacies? |
dispenser
hospital pharmacies-separate registration not required; can use dispenser's registration issued to hospital |
|
|
When must a pharmacy register as a CS distributer?
|
1)participates in joint buying activities, and is the location from which drugs are stored and shipped to other pharmacies
or 2)its annual distribution of CS's to other pharmacies or practitioners is >5% of total number of dosage units dispensed |
|
|
When must a pharmacy register as a CS's manufacturer?
|
1)purchases of CS's for purposes of repackaging for sale within a pharmacy or to other registrants
or 2)compounds for office use (If by RX, dispensers registration is all that is required) |
|
|
When is limited compounding for office use permitted?
|
1)compounded in aqueous, oleaginous, or solid dosage form
and 2)contain only up to 20% CS and 3)must be distributed to a practitioner who is also registered to dispense |
|
|
How to validate a DEA number
|
Begins with "A" or "B" and first letter of providers last name
Followed by 7 numbers -Add digits 1,3,5 -Add digits 2,4,6 and multiply sum by 2 -Add results and last number of summation should equal last number of DEA number |
|
|
What do DEA numbers starting with an "M" mean?
|
midlevel practitioner
ex. nurse practitioner, physician assistant, pharmacist |
|
|
Prescribing under hospital DEA number
|
Interns, residents, and foreign-trained physicians may dispense, administer, and prescribe CS's under the registration of the hospital or other institution
|
|
|
Hospital residents who practice on a part-time basis outside of the hospital must have a state medical registration number, and _______ prescribe under the authority of the hospital.
|
may not
|
|
|
Schedule 1 classification
|
little to no medical value
lacks acceptable therapeutic index high abuse potential -physiologically -psychologically |
|
|
Schedule 1 examples
|
methaqualone
peyote heroin, mescaline, LSD, marijuana |
|
|
Schedule II classification
|
Has medical value with or without severe restriction
high abuse potential -physiologically -psycholocially |
|
|
Schedule II examples
|
narcotic analgesics, amphetamine derivatives, barbiturates
tincture of opium methadone (Dolophine) pentobarbital (Nembutal) methamphetamine (Desoyn) oxycodone/APAP (Percocet) oxycodone/ASA (Percodan) |
|
|
Schedule III classification
|
Lower abuse potential than CI, CII
Abuse may lead to -low-mod physiologic dependence -high psychological dependence |
|
|
Schedule III examples
|
analgesics
ketamine (Ketlar) thiopental (Pentothal) anabolic steroids (Androderm, Halotestin, Testoderm, Winstrol) pentobarbital rectal supp (Nembutal supp) butalbital (Fiorinal) paregoric benzphetamine (Didrex) APAP/codeine (Tylenol 3) |
|
|
Schedule IV classification
|
less abuse potential than CI, CII, CII
limited physiologic and psychological dependence |
|
|
Schedule IV examples
|
anxiolytics
sedatives butorphanol (Stadol) pentazocin (Talwin NX) phentermine HCL (Fastin) propoxyphene (Darvon, Darvocet) phenobarbital meprobamate (Equanil, Miltown) Zaleplon (Sonata) |
|
|
Schedule V classification
|
low abuse potential and limited dependence compared to CI, CII, CII, CIV
|
|
|
Schedule V examples
|
cough, cold, antidiarrheals
APAP/codeine elixir lomotil cough syrups containing codeine pregabalin (Lyrica) |
|
|
GHB FDA approved drug products?
What schedule? |
Zyrem
GHB gamma hydroxybutyrate Schedule III sodium oxybate = schedule I |
|
|
Compounded/Combination products
Schedule III classification Codeine dihydrocodeine (hydrocodone) ethylmorphine opium morphine |
codeine= 1.8g/100mL or not more than 0.09g/dosage unit
hydrocodone = 0.3g/100mL or not more than 0.015g/dosage unit ethylmorphine= same as hydrocodone opium= <0.5g/100mL or 100g or not more than 0.025g/dosage unit morphine= 0.05g/100mL or 100g |
|
|
Compounded/Combination products
Schedule V classification codeine hydrocodone ethylmorphine diphenoxylate opium difenoxin |
codeine= 0.2g/100mL or 100g
ethylmorphine= 0.1g/100mL or 100g hydrocodone= same as ethylmorphine diphenoxylate = 0.0025g and not less than 25mcg atropine difenoxin= 0.0005g and not less than 25mcg atropine opium= 0.1g/100mL or 100g |
|
|
This is not a legitimate purpose for a CS RX
|
maintenance of a person's addiction
|
|
|
Self-prescribing of CS's
|
Neither federal or state prohibit
neither place a limit on quantity of CS that can be written or dispensed in a single RX But must use good faith |
|
|
Ordering Controlled Substances-
Schedule 1 and 2 must be ordered using _____ |
triplicate form DEA 222
|
|
|
How many copies of DEA form 222
|
three
|
|
|
What happens to each copy?
|
copy 1 and 2 go to supplier and 3 is maintained at the pharmacy or other recipient
supplier retains copy 1 and forwards copy 2 to DEA |
|
|
What color is each copy?
|
copy 1= brown
copy 2=green copy 3= blue |
|
|
DEA form 222 can only be completed by who?
|
registrants or individuals with a power of attorney
POA is given by DEA registrant |
|
|
Maximum of how many items per DEA 222 form?
|
10
|
|
|
How many items per line in DEA 222 form?
|
1
|
|
|
DEA form 222 must include:
|
number of lines completed
signature of purchaser or agent DEA number of pharmacy Date form issued |
|
|
Does not preclude _____ if customer agrees
|
generic substitution
|
|
|
Upon receipt of drugs, the _____ and ______ of items received are recorded and filed for _____ years.
|
date and number
2 years |
|
|
Storage-Federal:
Schedule II-V can be stored: |
in a locked container or dispersed throughout the pharmacy with non-controlled substances
|
|
|
Disposal-
Can be done by contacting: |
either local DEA office or State agency
|
|
|
Disposal-
DEA will authorize destruction by: |
2 responsible parties (agents of registrant, DEA personnel, state personnel, sending CS to authorized agency for destruction)
|
|
|
Disposal-
Authorized agencies for destruction |
State
DEA office |
|
|
Inventory and Record Keeping-
Federal Law: Initial inventory must be ___ and ____. The inventory must be kept for ___ years. C2 records must be kept _____. |
dated and timed
2 years separately |
|
|
____ including records of newly scheduled substances since last inventory;
CII must be ____ count CIII-V may be _____. Exception: any opened bottles of _____ dosage units or more--an exact count is warranted |
beiennial inventory records (every 2 years from the initial inventory)
exact count estimated 1000 |
|
|
Records of receipt of controlled substances (For CIIs, the ____, for all others, ____ invoices;
dispensing records (prescriptions and refill data); records of return or disposal; reports and estimates of controlled substances thefts (DEA ___); and records of amounts of CS used in compounding or discarded during the process of administration |
DEA 222
business invoices DEA 106 |
|
|
Illinois requires all prescription records to be maintained for ____ years.
|
5
|
|
|
Federal Biennial inventory-to be taken on any date within two years of the previous biennial inventory.
Requirements: 1)inventory should state whether it was taken at ____ or ____ of business 2)should be _____ by person taking the inventory 3)Record should be filed within the pharmacy for ____ years. 4)When new substances are scheduled, they must be inventoried _____, and filed with most recent inventory 5)For new pharmacies, it is not necessary to inventory _____; required copies of invoices and DEA 222 will suffice 6)For CIIs, an ____ is required. For CIII-CV, quantitites in containers less than _____ may be estimated, while containers of ____ or larger must be physically counted |
opening or close
signed 2 years on the date of official scheduling new stock actual count; 1000; 1000 |
|
|
Inventory contents:
|
1)name of drug
2)dosage form and unit strength 3)number of units or the volume in the container 4)number of containers |
|
|
A theft or significant loss must be reported on ____.
|
DEA form 106 and to the IDFPR
|
|
|
Contents of DEA 106
|
-name/address of pharmacy
-DEA registration number -Date of theft -name/telephone number of local PD notified -type of theft -listing of CS's missing from theft or significant loss -listing of symbols or cost code used by pharmacy in marking containers if any |
|
|
PIC required to file a copy of the DEA 106 or theft report to ____
|
DPR
|
|
|
In every instance that a PIC is required by federal law to file with the US DEA a report of theft or loss of CS's, Form 106, a copy shall be sent to ______
|
the department
|
|
|
Filling time limit for filling CII's under federal law
|
no time limit
|
|
|
Illinois time limit for filling CII RX's
|
7 days
|
|
|
Emergency CII RX's are allowed for what known parties?
A written prescription must be received by the pharmacy within ____ days of the emergency order. |
patients-hospice, cancer, chronic disease
prescribers 7 days |
|
|
Upon receipt of the back-up prescription, _______ must be indicated on the RX which is filed along with the emergency telephone prescription.
|
Authorized for Emergency Dispensing
|
|
|
Federal law prohibits fax C-II prescriptions, with what exceptions?
|
1)For C-IIs, the original must be presented before the CS is dispensed (illinois law silent)
2)For home infusion pharmacies and LTCF, federal law permits the fax to serve as the original (state law similar) 3)CSA was recently amended to allow FAX prescriptions to serve as original for hospice patients. |
|
|
What changes are permitted on a C-II prescription?
|
1)pts address
2)drug strength 3)drug quantity 4)directions for use |
|
|
What cannot be changed on a C-II prescription?
|
1)pts name
2)drug prescriber (except generic substitution) 3)date on rx 4)prescriber's signature |
|
|
What difference is there between federal and Illinois law regarding changes on C-II RX's?
|
federal: date can be added but not changed
state: date cannot be added or changed |
|
|
CII and CIV can be refilled how many times
|
5 refills, 6 months
|
|
|
CV can be refilled how many times
|
as many times as allowed by state controlled substance laws
|
|
|
Under Illinois law, can CIII-CV RX's be transmitted electronically?
|
No
|
|
|
How many times can refills be transferred?
|
once verbally between pharmacies
pharmacies linked electronically -federal law: up to number of times of refills authorized -state law: only 1 time, even if pharmacies share real time electronic database |
|
|
What must be recorded when transferring a refill?
|
1)date of transfer
2)pharmacist receiving 3)all required info from original RX 4)must have access to prescriber DEA |
|
|
Partial Dispensing of CS RX's-
C-IIs: may fill with partial quantity and may dispense remaining quantity within _____ of partial fill. If not filled within _____, pharmacist must _____ |
72 hours
contact prescriber, and cannot fill remaining quantity |
|
|
For what type of patients may partial CII quantities be dispensed?
|
LTCF and terminally ill patients
pharmacist must write it on prescription too |
|
|
For each partial fill, what must be recorded on the back of the RX or another appropriate record that is maintained and readily retrievable?
If this procedure is followed, the prescription shall be valid for ____. |
-date
-quantity dispensed -quantity remaining -identification of pharmacist 60 days |
|
|
For CIII, CIV, CV RX's, partial fills are permitted. Each partial fill should be recorded on ___.
What time limitation applies? |
RX
6month partial fills are not counted as full refills |
|
|
Narcotic Treatment Programs (NTPs) must register with the _____.
|
DEA
|
|
|
What are NTPs?
|
programs that use CS's for patients going through withdrawal from other narcotics
-Methadone (Dolophine) -Levo-alpha-acetyl-methadol (LAAM) |
|
|
What is the difference between maintenance treatment and detoxification treatment
|
maintenance: >21days= treatment of dependence
detoxification: the dispensing, for a period not in excess of 21 days of a narcotic drug in dec doses to an individual in order to alleviate adverse physiol or psychol effects incident to withdrawal from continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such a period of time |
|
|
When a patient is on methadone for detoxification, no methadone may be prescribed for ______ purposes.
If, however, a patient is NOT undergoing maintenance or detoxifiation treatment, methadone may be prescribed as an analgesic, and dispensed by any licensed pharmacy |
analgesic
|
|
|
What did the Drug Addiction Treatment Act passed by Congress in Oct 2000 do?
|
waived the requirement for a separate DEA registration as an opioid treatment program for practitioners who dispense or prescribe FDA-approved schedules III-V narcotic CS's for use in maintenance or detoxification treatmente
Allows physicians to provide addiction treatmnet in an office-based setting, thus expanding access to treatment |
|
|
In Oct 2002, the FDA approved 2 new _____ drug products (____), for use by _______ as permitted under the Drug Addiction Treatment Act.
|
buprenorphine (e.g., Suboxone)
physicians in office-based settings |
|
|
Are these buprenorphine substances available to NTPs?
|
not yet
|
|
|
Emergency Medication Kits in LTCF's-
Both the hospital or LTCF and the supplier must maintain accountability records for the controlled rugs and take periodic inventories including: |
-Proof-of-use sheet
-shift count done whenever kit is opened -consultant pharmacist shall check and document the CS's in the kit at least monthly |
|
|
Emergency Medication Kits in LTCFs cont.-
No more than ____ different controlled substances per kit No more than ____, injectable doses of each controlled substance After seal of an emergency kit has been broken, the kit shall be returned to the pharmacy or consultant pharmacist notified so that it can be checked and/or restocked within _____. |
10
3 single 24hours |
|
|
Federal vs. State Law-
pre-printed prescriptions |
federal: does not prohibit
state: prohibits (rubber stamped, photocopied, etc.) |
|
|
Federal vs. State Law-
CII drugs dispersed throughout inventory |
federal: can be dispersed
state: locked in cabinet/container |
|
|
Federal vs. State law-
Who administers and enforces controlled substance laws? |
federal: CS laws administered and enforced by DEA
state: administered by IDASA and DPR and enforced by DPR and state police (ISP) |
|
|
Federal vs. State law-
Who schedules drugs? |
federal: DEA
state: IDASA |
|
|
Federal vs. State law-
Length of retaining records |
federal: 2 years
state: illinois controlled substancce act-2 years; illinois pharmacy practice act-5years |
|
|
Federal vs. State- Requirement for dispensing C-V without RX
Age |
Federal: 18yrs
State: 21yrs |
|
|
Federal vs. State- Requirement for dispensing C-V without RX
Time limitation |
federal: at least 48 hours
state: 96 hours |
|
|
Federal vs. State- Requirement for dispensing C-V without RX
Records |
federal:
-initials of purchaser -date of sale -initials of RPh state: -signature of purchaser -signature of pharmacist -time of sale -certification of no purchases within 96 hours |
|
|
Federal vs. State- Requirement for dispensing C-V without RX
Reporting |
federal: maintain records for 2 years
state: maintain records for 2 years and send copy to IDPR by 15th of next month |
|
|
Federal vs. State- Requirement for dispensing C-V without RX
Possession limits |
federal: silent
state: not more than 4.5 L per drug product plus amount of product needed for dispensing during busiest week |
|
|
Federal vs. State- Requirement for dispensing C-V without RX
ID |
federal: must provide 1 valid ID
state: 2 valid IDs |
|
|
Federal vs. State- Requirement for dispensing C-V without RX
Refills |
federal: no max time limit or number of refills specified
state: max 5 refills or 6 months whichever comes first |
|
|
Section 316 Schedule II controlled substance prescription monitoring program
Each time a schedule II controlled substance is dispensed, the dispenser must transmit to the central repository the following information: |
1)recipient's name
2)recipient's address 3)national drug code number of schedule II dispensed 4)date of schedule II dispensed 5)quantity 6)dispenser's US DEA registration number 7)prescriber's US DEA registration number |
|
|
Section 316 Schedule II controlled substance prescription monitoring program
The information required to be transmitted under this section must be transmitted _____ after the date on which a schedule II controlled substance is dispensed |
not more than 15 days
|
|
|
Section 316 Schedule II controlled substance prescription monitoring program
There is no requirement that you must transmit a _____ if you have not filled any schedule II prescriptions, nor is there a requirement to transmit the sex of the patient. |
a zero (0)
|
|
|
Federal Food, Drug, and Cosmetic Act-
All drug manufacturers and repackagers are required to register with the _____. If they fail to register, their products are deemed to be ______. |
FDA
Misbranded |
|
|
Classification of drugs-
A drug is a substance which is: -recognized in ____ or _____ -intended for use in ____ of disease -_____article intended to affect _______ of the body; or -intended to be used as a ______ of an item failling within any of these categories |
USP/NF or Homeopathic pharmacopoeia
diagnosis, cure, mitigation, treatment or prevention non-food; structure or function component |
|
|
Three key points about classification of drugs-
-no distinction between _____ -key element is often the ____ of the manufacturer or distributer -classifications are not mutually exclusive |
RX or OTC
intent |
|
|
Prescription Drugs-
Drugs which cannot be made safe including ________ (and is therefore exempt from requirement that it contain adequate directions for use or be considered misbranded). |
adequate directions for use
|
|
|
Prescription Drugs-
Is limited to dispensing by a prescription because it is _______ has a _______, or its NDA limits it to use under a doctor's supervision |
haabit forming, toxic
potential for harm |
|
|
Prescription Drugs-
Label must contain "legend" stating: ________ |
Caution: Federal law prohibits dispensing without a prescription (Now: Rx only)
|
|
|
Prescription Drug Marketing Act of 1987-
Amends the FDCA to: |
-require states to license wholesale distributors of RX drugs
-ban the reimportation of RX drugs, except by manufacturer or for emergency use -mandate storage, handling, and recordkeeping requirements for drug samples -ban trafficking or counterfeiting of drug coupons -prohibit resale of RX drugs purchased by hospitals or health care facilities, w/ certain exceptions |
|
|
Durham-Humphrey Amendments to FDCA
|
Provides that RX drugs can be dispensed:
-only upon written RX of practitioner -oral RX reduced to writing -refilling where authorized -by administration directly by prescriber |
|
|
The DHA prohibit _____.
|
unauthorized refills
|
|
|
Determination of who may prescribe is made by _____.
|
state law
|
|
|
Misbranded Drugs definition
|
drugs which are sold, distributed, or dispensed in violation with the labeling requirements of FDCA
|
|
|
Misbranding occurs when a pharmacist ______
|
dispenses w/o RX or authorized refill
|
|
|
Labeling includes:
|
-package insert
-drug advertisements -information in publication such as PDR -promotional materials, including newsletters and literature used in promotion |
|
|
6 requirements on RX label according to Federal Law
|
1)name and address of dispenser
2)serial number of RX 3)date of RX or date of filling? 4)name of prescriber 5)name of patient 6)directions for use, including precautions Illinois law is stricter and requires the drug name to appear |
|
|
Adulteration definition
|
Failure of a drug or device to satisfy FDA purity standards
|
|
|
Repackaged OTC products labeling (8)
|
same as for commercial
1)name of product, and pharmacological category 2)name and address of manufacturer 3)net content of product 4)active ingredients and quantity of certain other ingredients 5)name of any habit forming drugs 6)storage instructions 7)cautions and warnings 8)directions |
|
|
3 levels of recall
|
Class I Recall- serious adverse health consequences
Class II Recall- temporary/reversible adverse health consquences Class III Recall-not likely to cause serious adverse health consequences |
|
|
Drug approval process
|
Step 1: in vivo animal studies to evaluate pharmacology and toxicities followed by submission of Investigational New Drug Application (IND)
Step 2: IND- contains preclinical data, proposed use and safety data, and proposed plan for study in humans FDA reviews and decides 3)clinical trials |
|
|
3 phases of clinical trials
|
Phase 1: small group of healthy subjects receive drug for evaluation of toxicity, pharmacokinetic, and pharmacologic properties; assessment of safety of drugs in humans
Phase 2: >100 more people w/ disease treated with drug to determine effectiveness and obtain info about dosing, safety, and adverse effects Phase 3: given to large group of patients to obtain data concerning drugs effectiveness compared to placebo |
|
|
Once all 3 phases of clinical trials are complete, than what happens?
|
New Drug Application (NDA) submitted to FDA and reviewed
|
|
|
Phase 4 studies: Post Marketing Surveillance
|
monitor use of drug for additional info regarding safety and effectiveness and report to FDA yearly
-health care practitioners voluntarily report adverse effects to FDA or manufacturer -reporting by manufacturer of information received is mandatory |
|
|
Purpose of Poison Prevention Packaging Act
|
provide special packaging to protect children under age of 5 from accidental poisoning
|
|
|
Products exempt from the PPPA:
|
-SL nitroglyerin tablets (Nitrostat)
-SL and chewable isosorbide dinitrate tables in doses <10mg -effervescent ASA or APAP tabs -Oral contraceptives packaged in "dial-packs" -unit dose potassium supplements -cholestyramine and colestipol powder -aerosal inhalation products |
|
|
Iron Supplements
|
Must put warning label on iron products
requirement of packaging in unit dose containers no longer applies, but the child resistant packaging requirement remains in place (>250mg elemental iron?) |
|
|
An OTC drug product for retail sale that is not packaged in a tamper-resistant package or that is not properly labeled under this section is deemed to be _____.
|
adultered and/or misbranded
|
|
|
Package Insert Requirements- Estrogen Products
|
Federal law requires that estrogen products be dispensed with an FDA approved patient information insert.
|
|
|
An estrogen drug product that does not comply with the requirements of this section is _____ under section 502 of the FDCA.
|
misbranded
|
|
|
Patient package inserts for estrogens dispensed in acute-care hospitals or LTCF's will be considered to have been provided in accordance with this section if provided to the patient ______.
|
before administration of the first estrogen and every 30 days thereafter, as long as therapy continues
|
|
|
Package Insert Requirements-Estrogen Products:
Exemptions |
estrogen-progestogen oral contraceptives
|
|
|
Package Insert Requirements- Oral contraceptives
|
Same as estrogen
|
|
|
When is Ipecac syrup available without RX?
|
-packaged in quantity of 1 oz (30mL)
-label: *statement boxed and in red letters: "For emergency use to cause vomitin in poisoning. Before use, call physician..etc."; *a warning "keep out of reach of children. Do not use in unconscious persons, etc" *usual dosage: 1 tablespoon (15mLs) in persons over 1 year of age |
|
|
ILLINOIS PHARMACY PRACTICE ACT AND ADMINSTRATIVE RULES
|
""
|
|
|
Regulatory controls are created and maintained by ____
|
the Department of Professional Regulation (DPR)
|
|
|
_____ advises the Director of DPR
|
Board of pharmacy
|
|
|
Board membership is appointed by who?
|
Governor
|
|
|
Board membership consists of:
|
-7 pharmacists
-2 public members |
|
|
Board membership terms
|
5 year terms- no more than 12 consecutive years
|
|
|
Pharmaceutical care does not include:
|
sale of OTC medications
|
|
|
Division I
|
Community or Retail
|
|
|
Division II
|
Off-site hospital or SNF
|
|
|
Division III
|
On-site hospital or SNF
|
|
|
ILLINOIS PHARMACY PRACTICE ACT AND ADMINSTRATIVE RULES
|
""
|
|
|
Regulatory controls are created and maintained by ____
|
the Department of Professional Regulation (DPR)
|
|
|
_____ advises the Director of DPR
|
Board of pharmacy
|
|
|
Board membership is appointed by who?
|
Governor
|
|
|
Board membership consists of:
|
-7 pharmacists
-2 public members |
|
|
Board membership terms
|
5 year terms- no more than 12 consecutive years
|
|
|
Pharmaceutical care does not include:
|
sale of OTC medications
|
|
|
Division I
|
Community or Retail
|
|
|
Division II
|
Off-site hospital or SNF
|
|
|
Division III
|
On-site hospital or SNF
|
|
|
Division IV
|
Nuclear or radiopharmacy
|
|
|
Division V
|
Outpatient
|
|
|
Division VI
|
remote order entry and review for facilities serviced by division II or III pharmacies.
Provides cognitive services only, and does not dispense drugs |
|
|
Space requirement for a pharmacy
|
300 square feet
|
|
|
Reference requirements for a pharmacy
|
-current editions of US Pharmacopoeia/DI
-Facts and Comparisons -Other *current compendium approved by the Department *pharmacy practice ACt and Rules of Administration *CSA and Rules of Administration |
|
|
Record retention time
|
not less than 5 years
readily retrievable record of all RX's |
|
|
Schedule V purchasing notes
|
-cannot be purchased by an individual more frequently than q96hours (4days)
-purchaser must sign a DPR form attesting this -purchaser must be 21 years old w/ 2 forms of ID -a copy of monthly schedule V sales log must be sent to the DPR by the 15th of the month following the sale |
|
|
Four things required to substitute a drug product
|
-prescriber must not prohibit
-patient informed consent -product included in Illinois Formulatry -product dispensed must have lower unit cost that product prescribed Pharmacist must indicate on RX the name or other identification of the manufacturer of the dispensed product |
|
|
Criteria for Formulary Inclusion
|
-Orange Book plus DPH "Notification List"
-All products must have approved NDA or ANDA -All products must meet FDA bioequivalent requirements -Products found to be ineffectivive in FDA's DESI review, but not yet removed from market, are excluded |
|
|
Inpatient drug orders: orders for patients or residents in a SNF or Hospital-
____ not required for CS's ordered at these facilities |
DEA
|
|
|
Transfer of RX's-
Pharmacist receiving the RX must: |
record all information needed for a valid RX and record name of RPh giving prescription
|
|
|
Transfer of RX's-
Pharmacist transferring the RX must invalidate the prescription and record: |
-date of transfer
-whom the RX was transferred to -name of pharmacist |
|
|
Schedule III to V may be transferred:
Verbally how many times? Electronically how many times? |
1 time verbally
electronically up to maximum allowed by law and prescriber's authorization |
|
|
Is Illinois an orange book state?
|
No
Generic dispensed must be on the Illinois Drug Product Selection Program Formulary |
|
|
Legend for all prescription medications
|
"Caution: Federal Law prohibits dispensing without prescription"
|
|
|
Legend for controlled substances
|
"Federal law prohibits transfer of this drug to any person other than the patient for whom it was prescribed"
|
|
|
Pharmacy technician certification requirements
|
-submit application for certificate of registration w/in 60days of beginning to assist pharmacist
-16 years of age or older -copy of proof of enrollement in high school, high school diploma, GED -application fee |
|
|
As of January 1, 2004, a ____ and ____are responsible for its pharmacy technicians being trained or for obtaining proof of prior training on topics
|
pharmacy and its PIC
|
|
|
5 things a registered technician cannot do
|
1)sell C-Vs
2)dispense in absence of pharmacist 3)transfer RX to another pharmacy 4)be in pharmacy when C-IIs are not secured (unless RPh is present) 5)counsel patients |
|
|
Within how long after initial employment or changing the duties and responsibilities of a pharmacy technician, it shall be the joint responsibility of the pharmacy and the PIC to train the pharmacy technician or obtain proof...etc.
|
6 months
|
|
|
Pharmacist Licensure Requirements-
Completion of ____ of apprenticeship under the direct supervision of an Illinois registered pharmacist |
400 hours
|
|
|
Pharmacist Licensure Requirements-
Pass State Board Exam with scaled score of at least _____ on both sections |
75
|
|
|
Expiration and renewal of licenses
|
licenses are valid for 2 years
For renewal, a total of 30 hours of CE are required |
|
|
Pharmacist in Charge-
For divisions ______, operations of pharmacy and maintenance of security provisions are the dual responsibility of PIC and Owner |
I, II, IV, V
|
|
|
For division ____, operations and security are the sole responsibility of PIC.
|
III
|
|
|
C-II dispensing records reporting
|
to DHHS by 15th of month following dispensing
|
|
|
C-V sales log reporting
|
to IDPR by 15th of month following sale
|
|
|
Notifying Department of change in PIC and CS inventory within ____ of change.
Inventory to be preserved at pharmacy for _____. Affidavit signed by outgoing and incoming PIC attesting to (1) completion of inventory, (2) preservation of inventory record, and (3) date of inventory to be provided to Department within ____ |
10 days
5 years 10 days |
|
|
Mid-Level Practitioner Prescribing Authority-
Prescriptions written by MLPs must contain the name (but not the signature) of the supervising physician. If the prescription is for a schedule III, IV, or V CS, the MLP must include ______. May not prescribe a CS under the physician's DEA number |
his or her own invdidual DEA number
|
|
|
Hypodermic syringes and needles act-
Requirements for sale of a syringe or needle without a prescription: |
18 years or older
purchase up to 20 sterile hypodermic syringes daily w/o an RX No record keeping requirements Illinois Department of Public Health must provide materials for proper disposal of needles and syringes to the pharmacies that choose to sell them |
|
|
ILLINOIS CONTROLLED SUBSTANCES REGULATION
|
''
|
|
|
Illinois Department of Human Services (IDHS) responsibilities
|
-authority to add substance to, delete, or reschedule all CS's
|
|
|
Methamphetamine precursors (ephedrine and pseudoephedrine) schedule
|
schedule V
|
|
|
Dextromethorphan schedule
|
schedule II unless formulated, packaged, and sold as an OTC
|
|
|
Talwin NX schedule
|
schedule III in IL, CIV federally
|
|
|
Registration-
Requires manufacturer, distributors, and dispensers (pharmacies) to register with the Illinois Department of Professional and Financial Regulation that expires: |
same date as pharmacy license (every 2 years)
|
|
|
Are allowed to inspect premises of registrants
|
IDPFR and State Police
|
|
|
Inventories: according to federal law, keep inventory records for ____ years. Not addressed by IL law
|
2 years
|
|
|
Prescriptions: according to Illinois Pharmacy Practice Act, all RX records must be kept for ____ years. CSA states 2 years, but IPPA prevails.
|
5 years
|
|
|
Records of Dispersal-
Prescriptions may be filed in one of three ways: |
1)three separate files
C-II, CIII-CV, Non CS RXs 2)two separate files C-II, C-III-C-V, non CS RX's 3)two separate files C-II-CV (red C on C-III, CIV, CV), non CS RX's |
|
|
Emergency Oral CII Orders/CII Quantities-
Same requirement for emergency oral RX orders under as under Federal Law, plus: |
1)state reason for oral RX
2)if prescriber fails to deliver a written order within 7 days, the pharmacist shall notify the IDHS and DEA 3)written CII RXs to include "both a written and numberical notation of quantity on the face of RX" |
|
|
Dispensing Prescriptions for Controlled Substances-
Pharmacist or dispensing prescriber must _____ and ____ the face of the prescription upon filling. |
sign own signature and date
|
|
|
Requirements for Dispensing CS-
CII RX's for compounding and IV administration to patient at _____ can be faxed by prescriber or his agent |
private residence, hospice, or LTCF
|
|
|
Can RPhs fill CII prescriptions from out of state prescribers?
|
Yes
|
|
|
Prescriptions for Schedule II controlled substances-
difference between state and federal law |
CII can only be prepared by the physician (unlike federal law)
|
|
|
Can prescriptions be used to obtain CS for prescriber's office use?
|
No (use invoice or, for CII, DEA 222 form)
|
|
|
OTC sale of schedule V controlled substances-
No person shall purchase or be dispensed more than _____ mLs or more than ____ grams of any schedule V which contains codeine, dihydrocodeine, or any salts, or ethylmorphine, or any salts, in any ____ period. |
120mL
120grams 96 hour period |
|
|
OTC Sale of schedule V controlled substances-
RPH must record: |
-name and address of purchaser
-name and quantity of product -date of time of sale -RPh signature |
|
|
OTC Sale of Schedule V controlled substances-
Purchaser shall sign attesting that he has not purchased any schedule V wtihin the immediately preceding _____ . Copy of records of sale for each month forwarded to _____ by the _____ of the following month Records maintained for not less than 2 years -Illinois pharmacy practice act requires that records be kept for ____ years |
96hours
IDFPR; 15th 5 years |
|
|
Schedule V controlled Substances-
A pharmacy shall not maintain or keep in stock a quantity of schedule V controlled substances in excess of ____ for each substance, plus the additional quantity of controlled substances necessary to fill the largest number of prescription orders filled by that pharmacy for such controlled substances in any one week in the previous year. |
4.5Liters
|
|
|
CII Electronic Monitoring Program-
Each time a CII is dispensed, dispenser must transmit to a central repository what info? Transmit information no more than ____ after date of dispensing. |
-recipient's name
-recipient's addres -NDC # -Date RX was written -date and quantity dispensed -dispenser's DEA # -Prescriber's DEA # 15days |
|
|
Requirements for emergency medication kits
|
-proof of use sheet: to be completed when CS used
-whenever opened, consultant RPh shall be notified w/in 24hours -whenever opened, a count of all CS shall be done on every shift until kit is closed by consultant RPh -consultant pharmacist shall check the CS in the kit at least monthly and so document inside of the kit |
|
|
Transfer Between Pharmacies of Prescription Information for Refill purposes-
One-time transfer for the purpose of ______- allowed between two pharmacies (remember Federal CS rules only allows tranfer for the purpose of refilling too) Remember, too, that Federal law, and the ILpractice Act, allow pharmacies _________ to transfer back and forth up to maximum refills |
of refill dispensing
sharing real-time online database |
