PHARMACY LAW Flashcards
Illinois agencies responsible for MONITORING and ENFORCEMENT of the Illinois Act
- The Department of Human Services, Office of Alcoholism and Substance Abuse
- The Department of Financial and Professional Regulation
Responsible for enforcing controlled substances laws
DEA
Drug Enforcement Administration
How old must someone be to purchase “exempt narcotics” w/o prescription in Illinois
21 yo
Controlled Substances Act (CSA) what year and aka?
1970- aka Comprehensive Drug Abuse Prevention and Control Act of 1970
• gave FDA auth to determine the scheduling of Controlls
1973?
Creation of the DEA by DOJ
Removed scheduling from FDA to DEA
Closed system of distribution of Controlled Substances
• Access to controlled substances are restricted through _________ and ___________
- REGISTRATION
* SCHEDULING
Only exception to be able to accept a controlled substance back once it has left the closed system? (ex: patient was dispensed CII and brings it back to pharmacy)
1) dispensing error
2) recall of the drug
Schedule II (barbiturates, narcotic analgesics, amphetamines)
Pentobarbital (Nembutal) Secobarbital (Seconal) Oxycodone/APAP (Percocet) Oxycodone (Oxycontin, Percodan) Oxymorphone (Numorphan) Amphetamine Cocaine Codeine Sulfate or phosphate Fentanyl (Duragesic, Sublimaze) Sufentanil (Sufenta) Hydromorphone (Dilaudid) Mepiridine (Demerol) Methylphenidate (Ritalin) Methadone ( Dolophine) Morphine (MS Contin) Methamphetamine (Desoyn) Tincture of Opium ***********only in illinois: Tapentadol (nucynta), Lisdexamfetamine (Vyvanse), pentazocine (Talwin)
Schedule III (combo barbiturates, suppository forms of short acting barbiturates, anabolic steroids, mainly analgesics)
Acetaminophen with codeine (tylenol #3 GHB gamma hydroxybutyrate pharmaceutical prep is III ( GHB non- pharmaceutical is CII !!!!!!!!!) Anabolic Steroids (Testoderm, Winstrol Aprobarbital (Alurate) Butalbital (Fiorinal, Fioricet, Butisol, Esgic) Butalbarbital (Soneryl) Ketamine (Ketlar) Paregoric Pentobarbital suppository (Nembutal suppositories) Thiopental (Pentothal) Dihydrocodeine (Synalgos- DC) Hydrocodone/APAP (Vicodin, Lortab, Norco) Hydrocodone/Ibuprofen (Vicoprofen) Buprenorphine (Suboxone, subutex) Benzphetamine (Didrex) Phendimetrazine (Plegine)
Schedule IV (long acting barbiturates, anxiolytics, sedatives)
Phenobarbital alprazolam (xanax) Oxazeam (Serax) Zaleplon (Sonata) Zolpidem (Ambien) Clonazepam (Clonidine) Tenazepam (restoril) Lorazepam (Ativan) Butorphanol (stadol) Diazepam (Valium) Flurazepam (Dalmane)
Schedule V (EXEMPT narcotics, cough, cold, antidiarrheals
acetaminophen w/ codeine ELIXIR Ephedrine and Pseudophedrine ACTIFED w/codeine Phenergan w/ codeine Robitussin A-C with Codeine Robitussin DAC with Codeine Triaminic Expetorant with Codeine Diphenoxylate with Atropine (Lomotil) Pregabalin (Lyrica)
**products containing ≤ 10 mgs of dihydrocodeine per 100 mL or Grams
Entry point for newly scheduled controlled drugs
Schedule **IV**
Schedule I definition
NO CURRENTLY ACCEPTABLE MEDICAL USE
- MESCALINE
- MARYJANE
- METHAQUALONE
- PEYOTE
SCHEDULE II definition
accepted medical use
• high abuse potential
• SEVERE phychological or physical dependence
Schedule III definition
Abuse potential less than CII
• Moderate or low physical dependence
• High Psychological dependence
Amount limit of ACETAMINOPHEN in Hydrocodone/APAP
Vicodin
Lortab
Norco
325 mg
Norco = 325 mg
Vicodin = 300 mg
CIV definitions
limited physical or psychological dependence
C V definition
• limited physical and psychological dependence COMPARED to CIV
**EXEMPT NARCOTICS***
Limited amounts can be purchased WITHOUT RX
Exempt narcotics (Schedule V) can be sold by? What is law on sale of these
• ONLY PHARMACIST CAN SELL EXEMPT NARCOTIC (ONCE ALL THE BELOW IS DONE THE TECHNICIAN CAN RING UP PRODUCT)
**EPH & PSE are different technician can do all**
• not more than 120 mLs in 96 hour period
• 21 yo
• 2 positive forms of ID
• Signature of purchaser and pharmacist, time of sale, CERTIFICATION of no purchases within 96 hours
• maintain records for 2 yrs and send copy to IDPR before 15th of next month
• not more than 4.5 L per drug + amount needed for dispensing during busiest week
Methamphetamine precursors
EPH & PSE
can be sold out of pharmacies as CONVENIENCE pkgs
≤ 360 mg liquid or liquid filled capsule only
True or false
Prescriptions sent by fax are considered electronic prescriptions
Prescriptions sent by fax are NOT considered electronic prescriptions
who cannot act as an AGENT for practitioner
pharmacists or technicians
AGENTS can prepare a CS RX for practitioner for their signature
2 requirments to make controlled script good
1) diagnosis supports the prescribing of the CS
2) prescriber acting in the “usual course” of practice
A CII prescription is valid for how many days after date of issuance in ILLINOIS
90 days
no time limit is specified under FEDERAL LAW
What is the quantity limit for CII script?
30 day supply max
FEDERAL LAW has no quantity limit
CII prescriptions must be had signed (no fax or telephone RXs permitted) Only exceptions are:
Illinois law: might result in “loss of life” or “intense suffering”
limited to the amount needed during emergency period
*****must get written prescription from prescriber within 7 days
emergency CII RX must be written and sent to pharmacy within 7 days by prescriber and must state:
- “Authorization for Emergency Dispensing”
- Date of emergency prescription
- mail or in person (must be postmarked within 7 days)
- Attach to emergency oral RX
If Emergency RX not received “rat the doctor out” to:
DEA & DHS
Illinois Department Of Human services, Office of Alcoholism and Substance Abuse
***if not the emergency dispensing authority is voided
True or False. A CII RX can be legally faxed for the care of a patient in long term care, hospice and private residence. This includes for Oral, IV and Infusion dosage forms.
False!!!
Only faxes can be received are for compounded for INFUSION for direct administration to patient in a private residence, hospice program or long-term care facility
True or False. Post dating of CII Prescriptions is legal
False!!!!
Post dating of prescriptions is PROHIBITED!!!!!!!
Partial quantities of C-II substances can be dispensed at any time to these patients: Also how long is RX valid for?
- Long Term Care Facility patients
- Terminally ill patients
• RX valid for 60 days
Pharmacist must write “ Long term care patient” or “terminally ill patient” on RX
For each partial fill need to note on back of RX or other appropriate record: • date • # dispensed • # remaining • identification of RPH
Which records cannot be centrally stored?
- Form 222
- Prescriptions
- Inventory records
What 3 ways can you dispose of CS’
- return to supplier
- send to “reverse distributor”
- disposal or destruction by pharmacy
What form is used to destroy C-II if sent back to supplier or to a “reverse distributor”
DEA form 222
What form is needed for C-III thru C-V if sent back to supplier or to a “reverse distributor”
no form just written record of
• date
• name, strength, dosage form, quantitiy
• name, address and registration number of place you are returning it to (mfg, reverse distributor, supplier etc)
What is needed to dispose or destruct of CS’ by pharmacy?
- Registrant must request DEA authorization to dispose
- Complete DEA form 41 (Registrants Inventory of Drugs Surrendered)
- must list 2 witnesses, date of disposal, method
- both forms must be received by nearest DEA at least 2 weeks prior to disposal date
Ryan Height Law 2008
Internet pharmacy regulation
done because of illegal sales of CS’ on internet
• Need modification of DEA registration in order to sell CS’ over internet
**Most retail and mail order pharmacies have websites that allow patients to order refills, including controlled substances. The Ryan Haight registration requirements do NOT apply to these type of pharmacies!!!!*******
Emergency kit at LTCF; some requirements
- No more than 10 different CS’ per kit
- No more than 3 single injectable doses of each CS
- The consultant pharmacist shall receive and file for 2 years a copy of all completed proof of use sheets
- Whenever the kit is opened, the consultant pharmacist is to be notified within 24 hours
- The consultant pharmacist must check the CS in the kit monthly and document inside the kit
True or False. Narcotic Treatment Programs must register with the DEA.
True!!!!!!!!!!!!
they use Methadone and LAAM Levo-alpha-acetyl-methadol!!!!!!!
Drug Addiction Treatment Act 2000
waived requirement for a separate DEA registration as a opioid treatment program for practitioners who dispense or prescribe FDA approved Schedules III-V narcotic CS’ for use in MAINTENANCE or DETOXIFICATION treatment.
When prescribing buprenorphine ( Subutex and Suboxone) in out patient setting the prescriber must have?
regular DEA #
&
specially assigned DEA registration # that starts with : “X”
• This indicates prescriber has received waiver to treatment addiction on an outpatient basis
True or False. Illinois’ Prescription Monitoring Program only requires reporting of C-II substances
False
C-II, III, IV, V should be reported!!!
Illinois Prescription Monitoring Program must report the following information:
Patient's name Patient's address NDC Date Quantity Dispensers DEA # Prescribers DEA # Payment type Patient location code (other than those filled in retail)
Illinois Prescription Monitoring Program requires when filling a CS the reporting within how many days
7
fine $100 per day after due date
No need to transmit a zero (0) for no fill
Exemptions to IPMP
inpatient drug orders
medications dispensed in ER ≤72 hr supply
CS administered in NTP
CS administered via infusion in the home, hospital, LTC or hospice
Food Drug Act 1906
No MISBRANDING or ADULTERATED food and drugs!!!!
thats it nothing else (premarket approval, efficacy proof not needed yet)!!!!!
Federal Food Drug and Cosmetic Act 1938
SAFETY!!!!!!!
mfg must show safety to FDA
FDA can inspect MFG whse
legal def of medications, devices cosmetics and labeling
DURHAM-HUMPHREY AMENDMENT 1951
OTC VS RX!!!!!!!
DRUGS SOLD ONLY WITH AUTH OF HEALTH PROFESSIONAL
Kefauver-Harris Amendment 1962
- safety
- EFFECTIVENESS
- report AE’s
- Disclose risks to prescribers
- Informed consent for research
- FDA advertising auth
- New DRug Application
- issued GMP good mfg practicing guidelines
- Inspect mfg q 2 yrs
Anti-Tampering 1982
tamper-resistant packaging!!!
cosmetic liquid oral hygiene products, vaginal products, contact lens solutions, most OTC drugs be packaged
must be distinctive by design and must indicate to consumers what tamper-resistant measures are being used
makes tampering a felony up to 10yrs in jail
indicator or barrier to entry, which if breached or missing, can reasonable be expected to provide visible evidence to consumers that tampering has occurred
blister packs, film wrappers, aerosol containers, tape seals, break=away caps, foil paper or plastic pouches that “must be torn or broken to obtain the product
Prescription Drug Marketing Act 1987
Safeguards in the prescription drug distribution system to prevent the intor and retail sale of substandard, ineffective or counterfeit drugs
- requires wholesalers to get state licensed
- ban reimportation of rx drugs except by mfg for emergency
- storage, handling and record keeping for drug SAMPLES (not intended to be sold and intended to promote the sale of the drug)
- ban counterfeit coupons
- prohibit resale of rx drugs by hospitals and healthcare facilities
Pharmacist license
400 hours of apprenticeship under supervision of IL RPH while enrolled in pharm school
a score of 75 (not percent) on both nabplex and mpje
• theoretical and applied pharmaceutical sciences
• pharmacy Jurisprudence
• Illinois Law
• Federal Law
What happens if you fail 3 times
must furnish proof of remedial education on the subjects failed on the third exam
Pharmacy technician
16 yo ≥
in highschool, ged program, ged, or diploma
What 6 things can a technician not do?
- cannot COUNSEL patients
- cannot do a DRUG REGIMEN REVIEW or be involved in clinical conflict resolution
- cannot sell C-Vs
- CANNOT DISPENSE IN ABSENCE OF PHARMACIST
- TRANSFER RX TO ANOTHER PHARMACY
- BE IN PHARMACY WHEN C-II ARE NOT SECURED (UNLESS RPH IS PRESENT)
technician must take the PHARMACY TECHNICIAN CERTIFICATION BOARD (PTCB) within what time frame?
within 2 years of initial registration
***does not apply to those registered prior to Jan 1 2008
foreign graduates
• will be classified “student pharmacist”
• complete 1200 hours (within 24 months) and work as a student pharmacist for no more than 18 months after hours are complete
must
an applicant for registration as a tech may assis a pharmacist for a period of how long prior to issuance of certificate?
60 days
keep copy of app in pharmacy
certified pharm tech
• application
• 18≥
• either:
grad from tech school OR obtain documentation from current job stating that they have finished training and board approved test there
• paid fees
• passed national organization of certifying agencies test
HOW LONG DO YOU HAVE TO REPLACE PIC
30 DAYS
TRUE OR FALSE. A pharmacys license will expire 30 days after the PIC ceases to be PIC, unless a new PIC is named
True
continuing education requirements
30 hours each two years
TRUE OR FALSE. The CE requirement is waived for first renewal after initial licensure
true
DPR can waive CE requirment if
Board recommendation
Full-time service in armed service
Extreme hardship
pharmacy must open within how many days of licensure
30 days
hard copy printout of each days refill data has to have
Name and Dosage form of drug
The date of each refilling
The quantity dispensed
The name or initials of Rph in each refillino and the technician if applicable
The patient’s name
The prescriber’s name
The prescription number for the prescription
