Which law prohibited adulteration and misbranding and prevented false statements concerning drug's identity?
Pure Food and Drug Act (PFDA)
Which law required that Manufacturers must demonstrate drug safety to FDA PRIOR to marketing and gave
Food, Drug and Cosmetics Act (FDCA)
Which law established 2 classes of meds and is the drug law most commonly to be violated by pharmacists
Durham-Humphrey Amendment (DHA)
Which law required that Manufacturers must show effectiveness and safety and established GMP requirements
Kefauver-Harris Act Amendment
Which law Established sales restrictions and recordkeeping requirements for prescription drug samples
Prescription Drug Marketing Act (PDMA)
What are covered entities that are protected under HIPPA
1. Health plans
2. Healthcare clearinghouses
3. Healthcare providers
4. Business associates of covered entities
Aspects of the privacy rule that PHI may be disclosed:
1. To the individual
2. For treatment
3. For payment
4. Healthcare operations- workers compensation
PHI can be disclosed if pt gives authorization in writing for:
1. Psychotherapy notes
2. Marketing
3. Fundraising
4. Employment determination
5. Pre-enrollment underwriting
6. Any other non-treatment payment, and healthcare operations purpose
Safe Harbor Method 18 types of Identifiers
1. All geographic subdivisions smaller than a state
- All elements of dates (except year)
- Vehicle identifiers and serial numbers, including license plate numbers (license plate +VIN)
- Fax numbers
- URLs
- IP addresses
- MRNs
- Biometric identifiers (fingerprints and voice prints)
- Health plan beneficiary numbers
- Full face photographs and comparable images
- Account numbers
- Certificate/license numbers
- Any other unique identifying number
What application will be done for approval of generic products after innovator patent expires?
ANDA Abbreviated New Drug Application
Which application will be done for any changes in the info reviewed and approved by the FDA in the NDA or ANDA
Supplemental New Drug Application
What are the requirements for a pt requesting an treatment IND
1. Pt must not be in the clinical trial
2. Imminent life-threatening stage of illness without cure and IND shows promise
3. Trial and failure or no commercially available effective drug approved
Dietary supplements are "food products"
True
Dietary supplements labeling:
- “Regular use will help maintain healthy cholesterol levels”
- Disclaimer: claims made on the label “have not been evaluated or approved by the Food and Drug Administration”
- Cannot make “drug” claims
RX dogs can be made safe by including adequate directions for use and expert agree that adequate directions for self-medication can be provided?
FALSE
Non-prescription drugs are recognized by experts as safe and effective?
TRUE
FDA labeling requirements
- Name and address of dispenser
- Serial number of Rx
- Date of Rx or date of filling (State law)
- Prescriber name
- Patient name if stated on Rx
- Directions for use, including precautions, if any, as indicated on Rx
Class I recall
ADULTERATION:
Reasonable probability of SERIOUS adverse health consequences/death
Class II recall
Temporary or reversible adverse health consequence or probability of serious health consequences is low
Class III recall
Not likely to cause serious adverse health consequences
Estrogen products:
Must have package insert containing benefits and risks
OCPs
Its must be fully informed of benefits and risks
Must have package insert
What warning must be be on OTC products with salicylates
- “Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away”
Safety closures are required for OTC salicylates?
False
- RECOMMENDED
What are the three categories for the Pregnancy and Lactation Labeling Rule
1. Pregnancy: Labor/deliver
2. Lactation: Nursing mothers
3. Females and Males of reproductive age
What 4 classes are exempt from tamper evident packaging?
1. Dermatological
2. Dentrifice
3. Insulin
4. Lozenges
Glass bottles can be replaced but MUST replace the cap?
True
What products are exempt from poison prevention?
- SL nitroglycerin
- SL and chewable isosorbide dinitrate ≤10 mg
- Effervescent ASA or APAP tabs
- Unit dose K supplements
- Cholestyramine and colestipol powder
- Aerosol inhalation products
What warning must be on OTC iron products?
- WARNING: accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
- Must be in child resistant packaging
Which products must be in child-resistant packaging?
Iron
What are the 4 powers of the IDFPR?
1. Rulemaking
2. Discipline
3. Licensing
4. Variances
How many years of experience must the IL Chief Pharmacy Coordinator have?
5 years
How many members make up the State board of pharmacy
11 members
How many pharmacist are on the State board of pharmacy?
8
1 must be an inpatient pharmacist
How many pharmacy techs are on the State board of pharmacy?
1
How many year terms are allowable for members of the State board?
5 yr terms
How many terms can a member serve on the state board?
2 terms
When do pharmacists licenses expire?
March 31st of EVEN NUMBERED YEARS
How many years from passing a licensing exam do you have to apply for licensure?
ONE YEAR
What examination must be passed to transfer a license?
Illinois multi-state jurisprudence exam
How many CE hours are required to renew a pharmacy license?
30 hrs
One hour each much be done for which CE's for pharmacists?
Sexual harassment
Implicit bias
A pharmacy license can be placed on inactive status?
False
If license expired for 5 years of less, pharmacist shall have the license renewed upon payment of all lapsed renewal fees and proof of 30 hours of CE
True
If license placed on inactive status for 5 years or less, pharmacist shall have the license restored upon payment of current renewal fee and proof of 30 hours of CE
True
- License expired or inactive for more than 5 years
30 hrs of CE
600 hrs of clinical practice
Successful completion of Pharmacist Assessment for Remediation Evaluation (PARE)
How many years do techs have to become a CPhT
2
When do technicians licenses expire?
Expires on March 31st of every year
How many CE hours do techs need?
20 hrs
Which three subjects must techs do CEs on?
1. Sexual harassment
2. Patient safety
3. Pharmacy law
What are the 6 tasks that techs cannot due:
- Sell exempt narcotics (promethazine with codeine without RX)
- Transfer controlled substance prescriptions
- Dispense in the absence of pharmacist- exceptions
-
Counsel patients- may only:
- Obtain med history
- Provide an OFFER to counsel by a pharmacist/student pharmacist
- Acquiring patient’s allergies and health conditions
- Drug regimen review
- Clinical conflict resolution
Interns who drop out, don't pass exams, or fail licensure 3 times can become a registered certified pharmacy tech?
True
Pharmacist in IL can prescribe and administer COVID-19 and flu vaccines to pts 7 and up?
True
Pharmacy licensed under PPA shall not require a pharmacist, student pharmacist or pharmacy technician to work more than 12 continuous hours per day, inclusive of breaks
True
What are the three exceptions to the 72 hour supply for dispensing from the ER?
1. Antimicrobials
2. Unit of use packages
3. Drugs dispenses via RAPSs
Drug administration under the PPA is limited to what routes?
Oral
Topical
Injectable
Inhalation
Pharmacist care must be inclusive of dispensing of drugs/devices?
FALSE
If out of date drugs are in stock a pharmacy license can be issues?
False
How much stock does someone have to own to be considered an "owner"
5%
Pharmacy licenses expire at the same frequency as pharmacist licenses?
True
A PIC can be a PIC at more than 1 location?
True
How many hrs must a PIC work at their home location?
8
2 conditions when you would need to file a new pharmacy application?
>10% of ownership changes
>50% of board of directors changes
IDFPR can refuse to issue or suspend a license of a pharmacist who fails to pay their taxes?
True
When can a pharmacists license be revoked?
Conviction a second time of committing any felony
A pharmacy's hours must be conspicuously displayed?
True: If they differ from front store
What are the exceptions to the duty to dispense rule?
1. Clinical reason
2. Emergencies/guidelines affecting availability
3. Lack of specialized equipment
4. Potentially fraudulent prescriptions
5. OOS
6. Drug is not typically carried in similar practice settings
Who do off-site institutional pharmacies serve?
Patients and residents
Medications for future use in off-site institutional pharmacies must have reference code to identify source and lot #, BUD, and expiration date?
True
What is unique about IV meds for future use in off-site institutional pharmacies?
Name, concentration, and volume of the base parenteral solution and date of admixture
Medications for immediate use in in off-site institutional pharmacies must have BUD?
Only if BUD <60 days from dispensing date
Meds to a specific pt via unit dose need BUD?
False
Who can be serviced by on-site institutional pharmacies?
patients
residents
employees
prescribers
students
Unique requirement for sterile solns in on-site institutional pharmacies?
Reference code to identify source and lot #
Unique requirement for investigational new drugs?
“For investigational use only”
Unique requirement for RX copies to pts?
“For Information Purposes Only”
Where are non-resident pharmacies licensed?
In the state where the dispensing facility is located and from which drugs are dispensed
Which type of pharmacy has to have a Toll free number with a pharmacist available 40 hours over at least 6 days per week
non-resident pharmacies
Have many feet of space is required for nuclear pharmacies?
At least 300 ft2
What unique requirements are for nuclear RXs OUTER CONTAINER?
1. Amount of radioactive material
2. Requested calibration time and amount of radioactivity contained
3. Name or initials of nuclear pharmacist
What unique requirements are for nuclear RXs INNER CONTAINER?
Name and address of pharmacy
A pharmacist can dispense an emergency supply for acute medications?
False- chronic
What 2 conditions must be met for generic substitution?
1. Physician does not prohibit
2. Selected product is cheaper than brand
Prescription requirements in IL:
- Patient name
- Date of issuance
- Name and strength of drug or description of medical device
- Quantity
- Directions for use
- Patient’s name, address, and signature
- DEA registration number where required for CS
active ingredients should be within how many % to be deem equivalent?
1%
For anti-seizure meds DRs may check the box of write do not substitute?
True
You are required to notify responsible person of generic change for anti-seizure drugs?
True
Pts must be notified of generic change for which two categories?
Biologics
ASDs
Dispensed medications can be returned for return/exchange?
False
When can drugs be returned?
For destruction only
Remote prescription processing systems must share the same owner/written contract?
True
Telepharmacies must counsel on all pick up even if a refill?
True
Telepharmacisies can share licenses?
False
- each on must have their own licenses
CII drugs need to be locked securely in remote dispensing sites?
False
How many remote sites can a pharmacist supervise that are simultaneously open
3
Technicians must be certified to work where?
Remote dispensing sites
RAPSs can be used by physicians?
False
Automated dispensing and storage systems Operate under the same license as pharmacy utilizing it
True
Automated dispensing and storage systems can allow direct patient access?
False
What are the exceptions for unit of use packages for Automated dispensing and storage systems?
1. Injectables in the original multi dose vials (insulin)
2. OTC products in their original multi dose container
Which method is used in institutions int he absence of a pharmacist?
- After hours cabinets
Which method meets the immediate needs of the patient, not available from another source in sufficient time
Emergency kits (crash carts)
How many hypodermic syringes and needles can be sold to an individual >/=18?
100