Arizona MPJE
When is a licensee "known" vs "confidential" when going through substance abuse treatment program and rehab?
"Confidential" if self-referred "Known" if ordered by the Board
Long-term care facility pharmacy services and emergency drugs Exterior labeling requirements of emergency drug supply unit
"For the emergency use only" Complete list of the contents stored in the unit Provider pharmacy's name, address, phone#, and pharmacist's initials Expiration date of the drug inside unit that has earliest expiration The date that the unit was last inspected and the ID of the responsible pharmacist Locked and sealed w/tamper-evident seal
Pharmacists shall place on the container the name of the drug or biological product dispensed followed up by the words "___ ___ ___" or "___ ___ ___ ___" followed by the ___ or ___ ___ of the product that is being replaced by the generic equivalent drug or interchangeable biological product.
"Generic equivalent for..." "Interchangeable biological product for..." brand, trade name
What area is specifically required for a drug wholesaler permittee
"Quarantine area" for storing products that... -expired -damaged -deteriorated -adulterated -counterfeited -contraband
What is the maximum civil penalty for violation of the pharmacy chapter?
$1,000
How are substance abuse treatment and rehab programs funded
$20 per biennial license renewal fee
What is the maximum handling fee for dispensing a drug from the drug donation program?
$4.50 per prescription
Pharmacist to intern ratio limit for COMMUNITY pharmacy and LIMITED-SERVICE pharmacy settings.
1 pharmacist to 2 interns in calendar quarter
What may be seized by the division of narcotics enforcement and criminal intelligence within the department of public safety when they have reasonable grounds to believe it is?
1) A drug that is counterfeit 2) A container of such counterfeit drug 3) Equipment used in manufacturing, compounding, or processing of a drug to which drug a prohibited act has occurred 4) Any item used in making of counterfeit drug 5) Any conveyance being used to transport, carry or hold counterfeit drug
Conditions of drug therapy management protocols for pharmacists
1) Actions that pharmacist can perform 2) Specific drugs to be managed by pharmacist 3) Conditions/events to notify provider 4) Lab tests that may be ordered 5) Provider must have provider-patient relationship
What are the facility requirements for drug wholesaler permittees
1) Adequate size/construction 2) Well-Lighted inside and out 3) Adequate ventilation 4) Clean, uncluttered, sanitary 5) Functional security system
Requirements for a pharmacist to make a therapeutic interchange from brand to generic? (Includes biologics)
1) All products dispensed have an expiration date on package 2) The manufacturer or distributor maintains recall and return capabilities for unsafe or defective drugs or biological products
Responsibilities of pharmacist with compounding
1) Approval or rejection of ingredients, containers/lids, and labeling 2) Preparation of compounding records 3) Reviewing records to ensure compounding process is error-free 4) Ensuring compounding equipment properly used, maintained, and cleaned 5) Initialing or signing the compounding record to indicate fulfillment of responsibilities
What must be done to get a Full-service drug wholesaler permit?
1) Approve permit application 2) Interview applicant and designated representative 3) Receive satisfactory facility inspection from Board inspector
Board must do what before a pharmacy permit is issued?
1) Approve permit application 2) Receive satisfactory inspection report from a Board compliance officer NOTE: Board may interview PIC and the applicant
Requirements to meet prior to issue of a drug manufacturer permit
1) Approve the permit application 2) Interview applicant and manager 3) Receive satisfactory facility inspection report from Board compliance officer
Patient eligibility Requirements to Receive Donated Prescription Medications
1) Arizona resident 2) Annual family income less than 300% poverty level 3) One of following: no insurance, insurance does not cover drug, Native American/Alaskan, Veterans, not eligible for Arizona Health Care Cost Containment System (Medicaid), Medicare eligible but NOT eligible for full low-income subsidy
Qualifications needed for a designated representative for a full service wholesaler permit?
1) At least 21 years old 2) 3 years experience in a wholesale pharmacy 3) Management level position 4) Actively involved in daily wholesale distribution 5) Physically present at business during hours 6) Can not be a designated representative for other business 7) Clear background check of Rx related crimes
Regulations regarding the storage of single-active ingredients Pseudoephedrine in a store?
1) Behind store counter or 2) Locked facility inaccessible to customers w/out assistance 3) Restrictions do not apply to liquid, liquid capsules, or gel capsules of these products
Qualifications for non-prescription drug vending machines?
1) Board-issued non-prescription drug permit for each machine 2) Board-issued ID seal affixed to each machine for public viewing, Seal contains following...: -permit #, -vending machine serial #, -owner's name/phone # 3) Stored in water-tight structure (building), protected from sunlight and maintained at a temp b/t 59-86 deg-F 4) Packaged and labeled in manufacturer's original packaing
Federal Controlled Substance Act Inventory counting procedures
1) C-II substances: EXACT COUNT is required regardless of size 2) C-II to C-V substances: -ESTIMATE for opened containers that hold less than or equal to 1,000 tabs/caps -EXACT count for opened containers that hold >1,000 tabs/caps
In addition to annual controlled substance inventory, what (3) situations must inventory of controlled substances be taken?
1) Changed in ownership of pharmacy 2) When pharmacy discontinued/closed 3) Within 10 days of a change in PIC
Omnibus Budget Reconciliation Act of 1990 When performing a DUR, the pharmacist should look for what 7 things
1) Clinical use/abuse 2) Drug-Dx interactions 3) DDI 4) Drug-ALL interactions 5) Incorrect Doses 6) Inappropriate Duration's of Tx 7) Therapeutic Duplication's
What must an applicant do to obtain a pharmacy permit
1) Complete application with fee 2) Documentations showing compliance with zoning laws (if required by Board) 3) Floor plan (size and security) 4) Copy of lease for building/space (if applicable) 5) Disclosure statement stating whether or not medical practitioner will receive direct or indirect compensation from pharmacy
Preceptor eligibility requirements
1) Current unrestricted pharmacy license 2) Have at least 1 year of experience as an active pharmacists AND 3) Hold a faculty position at pharmacy school/school of pharmacy experiential training OR Obtain Board-approval to act as preceptor
What additional information is required on prescriptions that are FAXED to be valid?
1) Date faxed 2) Fax # and phone # of location from where fax came 3) Name of person who sent fax (if someone different than practitioner)
What requirements must be met for a valid Refill Authorization to be FAXED from practitioner to pharmacy?
1) Date of authorization 2) Practitioner's signature OR name of practitioner's agent who sent fax 3) Practitioner's phone # and fax #
What information must be required on back of a prescription order to Document Dispensing of REFILLS
1) Date refilled 2) Quantity dispensed 3) Manufacturer's or distributor's name (or abbreviation) if generic/generic subs dispensed 4) Name or initials of dispensing pharmacist
What additional information is required for an e-prescription to be valid:
1) Date transmitted 2) Name of person who transmitted Rx (if sent by someone other than practitioner)
Information required on a PRESCRIPTION order
1) Date written 2) Name & address of patient or owner of animal 3) Drug name, strength, dosage form (if Device, name of Device only) 4) MFG or Distributor's name if written for generic/generic subs made 5) Directions for use 6) Date Dispensed 7) Qty prescribed & Qty Dispensed 8) Prescriber's authorization to dispense as indicated by the : ~Written Rx: Signature ~Electronic Rx: Electronic/Digital signature ~Oral Rx: Name & phone # 9) Name or Initials of dispensing Pharmacist 10) DEA # of Prescriber (ONLY if Controlled Rx)
Information required on Prescription order
1) Date written 2) Name, address of patient (or owner of pet) 3) Refills # 4) Name, address, phone # of prescriber 5) Name, strength, dosage form, and quantity 6) Directions for use
What must appear on prescription order in order for the prescription to be dispensed by a pharmacist?
1) Date written 2) Name/address of patient or owner of pet 3) Drug name, strength, dosage form or device name 4) Drug name or device mfg or distributor if generically written/substitution made 5) Directions for use 6) Date of dispensing 7) Qty prescribed and if diff. Qty dispensed 8) Name or initials of dispensing pharmacist "If Controlled Substance Rx order......." 9) Prescriber's address & DEA # 10) Prescriber's authorization to dispense -written rx order (signature) -electronic rx order (digital-.../e-sign) -oral rx order (name, telephone #)
What can a pharmacist change on a C-II prescription if authorized verbally by the prescriber?
1) Date written 2) Strength, Dosage form & Quantity 3) Directions for use pharmacist must record all changes w/the time & date of verbal authorization on the original Rx
Conditions of Dispensing Prescription Only drugs
1) Dispense by medical practitioner 2) Written prescription that is signed by provider 3) E-prescriptions that have electronic signature that is reduced to writing & filed by pharmacist 4) Written prescription generated electronically containing manual or E-signature. (Rx orders that contain only an E-signature must be applied to paper that uses Security Features) 5) Oral prescription that is reduced to writing & filed by pharmacist 6) Electronically transmitted or oral prescription order for refill that is documented & filed by pharmacist 7) Prescription order that is faxed or emailed by prescribing medical practitioner/ practitioner's prescribing agent 8) Prescription order faxed or e-mail by a patient as long as patient presents a written prescription order bearing the prescribing medical practitioner's manual signature
What documentation is needed when dispensing naloxone without a prescription?
1) Dispensing consistent with board rules 2) Instruction to patient/caregiver to call emergency personnel asap before or after giving naloxone
Federal Laws Dispensing methadone from a pharmacy
1) Dispensing methadone from pharmacy for treatment of Pain is PERMITTED 2) Dispensing for treating of Addiction is PROHIBITED
Drug manufacturer permittees must notify the EXECUTIVE DIRECTOR of the Board within 24 hours of changes in:
1) Drug list (i.e. drugs mfg, packaged, labeled/ relabeled by the business) 2) Ownership 3) Address 4) Phone number 5) Name of business 6) Manager, including manager's phone #
What Product Information is contained in a Pedigree
1) Drug name 2) Dosage form & strength 3) Container size 4) # of containers 5) lot # 6) MFG name
A certified pharmacist to give immunizations may give what type of injections/vaccines without a prescription order?
1) Emergency medication to manage anaphylaxis to vaccine 2) Vaccines to any person regardless of age during public health emergency response
Who is NOT required to register with DEA to handle controlled substances?
1) Employees of manufacturer, warehouse, distributor, or dispenser 2) Patients that have valid C-II Rx 3) Government-employed officers/employees lawfully performing duties
Record keeping requirements for C-III through C-V Rx orders
1) Filed separate from other Rx records Or 2) Can file with non-controlled Rx records with letter "C" in lower right hand corner using a font at lest 1 inch high
What vaccines can a pharmacist give to CHILDREN W/OUT a prescription order?
1) Flu vaccine to children at least 3 years of age 2) Booster doses for the primary adolescent series as recommended by CDC 3) Vaccines recommended by CDC for disease control and prevention to people at least 13y/o
What are the two types of wholesaler permits?
1) Full-service drug wholesale permits 2) Non-prescription drug wholesale permits
What (5) Non-pharmacy retailers must possess a current board issued non-prescription drug permit to sell or distribute non-prescription drugs
1) Grocery stores 2) Convenience stores 3) Health food stores 4) Swap-meet vendors 5) Vending Machines
In what 3 cases does a FAXED C-II prescription serve as the orig-Rx for record keeping purposes?
1) Home infusion 2) Long-term care 3) Hospice
Federal Controlled Substance Act Process allowed to issue multiple C-II prescriptions to same patient for same medication
1) Indicate earliest fill date on each Rx 2) Total amount prescribed does not exceed 90-day supply
Procedures to close pharmacy: Transferring controlled substances
1) Inventory must be taken 2) Copy of inventory accompanies controlled substances being transferred 3) Original inventory document kept for 3 years from when pharmacy closed 4) DEA 222 form must be used to document the transfer of C-II controlled substances
What are the requirements for LABELING WARNINGS on Poisonous/Hazardous substances?
1) Located prominently 2) English language 3) Conspicuous and legible
Prescription TRANSFER documentation requests: TRANSFERRING pharmacy
1) Must invalidate original Rx by writing "VOID" or invalidating in computer 2) Must record in computer system or on back of Rx the Receiving pharmacies: -name & ID code, number or address -telephone # 3) Name of pharmacist/intern receiving transfer 4) Name of pharmacist/intern transferring Rx out
Information required on Drug LABEL
1) Name & address of dispenser 2) Serial number 3) Date of dispensing 4) Name of prescriber 5) Name of patient/ owner of animal & species of animal 6) Directions for use 7) Cautionary statements, if any
Label requirements for Poisonous/Hazardous substances, if not considered misbranded
1) Name & address of manufacturer or seller 2) Common or usual name or chemical name 3) "Poison" or "danger" with skull and crossbones symbol which are highly toxic 4) "Danger" if corrosive 5) "Warning" or "caution" on all other products 6) Statement on principle poisonous property such as "Flammable", "vapor harmful", "Causes burns" or similar wording 7) Precautionary measures of actions to follow or avoid 8) First-aid instructions 9) Instructions on packages w/require special care in handling or storage 10) "Keep out of reach of children" 11) Directions for use
What information must a drug pedigree contain?
1) Name of Rx-only drug 2) Dosage form/strength 3) Size of container 4) # of containers 5) Lot # of Rx-only drug 6) Name of manufacturer of finished dosage form
What conditions are needed to dispense Replacement Soft Contact Lenses prescription
1) Name of provider/optometrist 2) Date of issuance 3) Includes: lens brand name, type, tint, and all other specifications necessary to dispense Rx
What documentation must be done by purchaser to return Rx-only medications to full service wholesale distributor?
1) Name, Strength, and MFG of each product 2) Statement that products were stored in compliance with label packaging
What information is required in the sale of a prescription drug only?
1) Name, address, number, and email (if available) 2) Name and address of each location shipped from 3) Transaction dates 4) Each recipient has verified drug pedigree
Procedure for filling an emergency C-II Rx
1) Oral order reduced to writing by pharmacist immediately 2) Prescriber must provide written, signed Rx to pharmacy within 7 days with "authorization for emergency dispensing" written on face of Rx w/ date of the oral order 3) Pharmacist must notify board if Rx not received within 7 days
When should a prescription order not be refilled
1) Order by the prescriber not to be refilled 2) More than one year since it was originally ordered
What conditions must be met in order for a pharmacist to initiate, modify, and monitor drug therapy?
1) Patient's drug therapy are pursuant to a provider 2) Comply with rules of board of pharmacy 3) Pharmacist follows written drug therapy management protocols prescribed by provider who made the diagnosis
Who can a full service wholesaler permittee furnish prescription drugs to?
1) Pharmacies 2) Medical practitioners NOTE: Must be delivered to address on purchaser's license or permit
Who can drug manufacturers distribute drugs to?
1) Pharmacies 2) Drug MFG 3) Full-service drug wholesale, 4) Non-prescription drug wholesalers, 5) Medical practitioners who are Properly licensed or permitted
What are (5) types of Non-Resident Permits
1) Pharmacy permit 2) MFG permit 3) Full-Service drug wholesale permit 4) Non-prescription drug wholesale permit 5) Non-prescription drug permit
Information required on label of prescription that is dispensed to patient
1) Pharmacy's name/address 2) Rx # 3) Date of dispensing 4) Prescriber's name 5) Patient's name (owner's name/species) 6) Directions for use 7) Cautionary statements
Non-prescription drug permits Must notify the Board within 10 days any changes of the following:
1) Phone number 2) Fax number 3) Mailing address 4) Email 5) Name of business
Prescriptions must be FAXED from the following to be valid
1) Practitioner's practice location 2) Nurse at a long-term care facility, or inpatient hospice facility if for patient at facility
What does a prescriber indication authorization to dispense a medication?
1) Prescriber's written signature of prescription 2) Electronic or digital signature 3) Prescriber's name and phone number if prescription is orally communicated
When can a full service wholesaler distributer NOT accept Rx-only medication returns or exchanges
1) Product adulterated or counterfeited (unless in response to FDA or manufacturer recall) 2) Amount being returned exceeds amount sold to pharmacy
What is required at the transaction of dextromethorphan?
1) Proof of age 2) Reasonably believe person > 25 yrs old based on appearance
Purpose of controlled substance Rx monitoring program
1) Provides database tracking system that tracks C-II through C-IV... -prescribing, -dispensing, -consumption 2) Assists law enforcement in identifying illegal activities 3) Provides info to help avoid inappropriate use of controlled substances
What must a pharmacist do after giving an Immunization, Vaccine or Emergency Medication?
1) Report to provider w/in 48hr after administration 2) Report information to vaccine registry 3) Maintain record of immunization 4) Report adverse reactions to provider w/in 24hr 5) Participate in federal vaccine adverse event reporting
When selling/distributing products into Arizona, Non-Resident permittees must comply with what (3) laws
1) Resident state law 2) Arizona law 3) Federal law
The requirement to stamp the hard copy Rx with a RED "C" is waived if a registrant employs an electronic data processing system or other electronic record keeping system for prescriptions that permits the identification by the...
1) Rx# 2) Retrieval of original documents by the... -Prescribers name -Patients name -Drug Dispensed -Date Filled
What type of prescription orders can be faxed to patient's pharmacy of choice?
1) Schedule III, IV, and V controlled substances 2) Rx-only drugs 3) Non-prescription drugs note: CII are faxed for informational purposes only
Prescription TRANSFER document requests: RECEIVING pharmacy
1) The word, "TRANSFER" 2) Date of issuance for orig-Rx 3) Oringal # of refills authorized 4) Date initially dispensed 5) # of refills remaining/date of last refill 6) Transferring pharmacy's name & ID code, number, or address 7) Transferring pharmacy's telephone # 8) Rx # for orig-Rx 9) Name of pharmacist/intern transferring Rx out 10) Name of pharmacist/intern receiving transfer note: for Controlled Substance Rx, each pharmacy must record the other pharmacy's DEA #
When can a pharmacist substitute a biological product for a prescribed biological product?
1) These conditions must be met: US FDA has determined interchangeable biological product 2) Physician does not designate that substitution is prohibited 3) Pharmacist informs patient of substitution 4) Within 5 business days after dispensing the pharmacist makes an entry of the specific product provided to patient with name and manufacturer and muust inform provider of change 5) Pharmacy retains a record of biological products dispensed
What changes must a drug wholesaler notify the EXECUTIVE DIRECTOR of the Board within 24 hours?
1) Type of drugs sold/distributed 2) Ownership 3) Address 4) Phone number 5) Name of business 6) Manager or designated representative
Pharmacy permittee must notify the board of changes within 10 day of the following:
1) Type of pharmacy operated 2) Phone number 3) Fax number 4) Email address 5) Mailing address 6) Name of business 7) Staff pharmacist
People who are not able to purchase dextromethorphan
1) Under 18 years of age 2) Commercial entity that knowingly sells to patients < 18 yrs old 3) Person that receives/distributes unfinished dextromethorphan, unless licensed by board
What immunizations can a pharmacist give to Adults W/OUT a prescription order?
1) Vaccines recommended for adults by the CDC 2) Vaccines recommend by CDC and prevention's health information for international travel
What information is required & recorded @ point of sale with Nonprescription products containing Pseudoephedrine or Ephedrine?
1) Valid Government issued photo ID 2) Name & address of purchaser 3) Name & quantity purchased 4) Date and time of purchase 5) Purchaser ID type and number
A current board-issued drug manufacture permit is required to do what (5) things to drug products
1) manufacture 2) package 3) re-package 4) label 5) re-label
Before relocating or retiring a Non-prescription drug permitted vending machine, the owner or manager shall notify the board in writing to include
1) permit # 2) vending machine's serial # 3) Action planned (relocate or retire) if retiring, the disposition of the non-Rx drug contents of the vending machine
Board notification requirements for non-resident permittees
1) w/in 10 days: -address, phone #, name of business, manager 2) Prior to change: -change in stock ownership of more than 30%
When should any pharmacy personnel notify the persons presenting the prescription of the amount of the price difference between the brand name drug or biological product prescribed and the Generic equivalent drug or interchangeable biological product?
1) when a medical practitioner does not indicate an intent to prevent substitution 2) when a transaction is not subject to 3rd party reimbursement
Biennial fee for a Drug wholesaler or manufacture permit; Manufacturer and Full service pharmacy
1,000
Minimum intern hour requirements for pharmacist licensure
1,500 hours
Fee for Duplicate Current renewal License
10
Fee for Duplicate of any Board-issued license, Registration, Certificate, or permit
10
wall license fee for Pharmacy intern/graduate, technician/tech-trainee
10
How much time does an intern have to report to the board due to change of address OR change of employer
10 days
Within how many days should the Board be notified after being charged with felony of misdemeanor that potentially affects patient safety
10 days
Biennial fee for a Durable Medical Equipment & Compressed Medical Gas Supplier permit
100
According to controlled substance law in Arizona, products containing Ephedrine as the single active ingredient are classified as a schedule V controlled substance. What is the OTC PURCHASE LIMIT?
100 dosage units per person in any 30 day period
Biennial fee Nonprescription drug, retail; Category 1 (30 or fewer items) retailer permit
120
Fee for Permit or Certificate verification
15
pharmacists Initial licensure fee upon passing the NAPLEX
180
DEA Number Verification 4-step process for numerical portion
1: Add 1st, 3rd, and 5th digits 2: Add 2nd, 4th, and 6th digits & multiply sum by 2 3: Add answers from step 1 and step 2 4: Sum obtained will be 2-digit number; 2nd digit of number will match 7th and final digit
NDC Number What do the three set of numbers mean?
1st: 5 digits, manufacturer 2nd: 4 digits, product 3rd: 2 digits, package size
DEA Number Verification Composition
2 letters followed by 7 numbers
wall license fee for Pharmacist
20
CE requirements for pharmacy techs
20 CE hours every 2 years Must include at least 2 credit hours of law If licensed for less than 24 months before first renewal date, must complete 0.83 multiplied by number of months license in 2 year period
Biennial fee Nonprescription drug, retail; Category 2 (More than 30 items) retailer permit
200
Biennial fee for a Compressed Medical Gas Distributor permit
200
Certificate fees of FREE SALE and GOOD MANUFACTURING PRACTICE
200
How are members of the Arizona State Board of Pharmacy compensated?
200 dollars each day Reimbursement for business expenses"
How long is a pharmacy tech training license valid for?
24 months
Thalidomid REMS (formerly known as S.T.E.P.S) Thalidomide Rx limits
28-day supply No refills or telephone prescriptions
How many times can you take the NAPLEX or MPJE prior to going before the board ofpharmacy?
3
How long should drug pedigree information be kept?
3 years
Combat Methamphetamine Epidemic Act (CMEA) of 2005 Daily purchase limits
3.6 grams/day
What are the limits of Methamphetamine precursors a person can buy in a DAY
3.6 grams/day
CE requirements for pharmacists
30 CE hours every 2 years Must include 3 hours of law If licensed for less than 24 months before first renewal date, must complete 1.25 multiplied by number of months license in 2 year period
How many days in advance must a pharmacy submit a new application to the Board when a pharmacy is RELOCATED or REMODELED?
30 days
How much time do you have to destroy drugs that are expired in drug donation program?
30 days Documentation must be kept for at least 3 years
How long before relocation must you submit your paperwork to relocate with non-prescription drug permit?
30 days before relocating
An applicant for reciprocal licensure as a pharmacist shall pay a fee of not more than
300
Limited-service mail-order pharmacy Minimum space requirement
300 square feet + 60 feet per person working at one time > 3 people Counter space at least 3 square feeing/licensee working at one time Separate patient counseling area 30 square feet for each person working simultaneously in the non-dispensing areas
Limited-service nuclear pharmacies Minimum space requirements
300 square feet for radiopharmaceutical compounding and dispensing area that is completely separate from pharmacy areas for non-radioactive drugs 80 square feet for a hot lab and storage area 30 square feet for each person working in non-dispensing areas
Penalty equal to half the Licensees & Permittees biennial permit fee is how much
350
licensure fee for pharmacy tech-trainees is how much and expires how long after issued
36, 24mos
Full Service Wholesale Distributors must maintain Inventory and Transaction Records for how long?
3yrs
Correctional pharmacy How long does a pharmacist have to verify drug removal records after returning from absence
4 hours
Proprietor, Manager, or PIC must be able to provide Invoices, Stock transfer documents, merchandise return memos, and other documentation related to the acquisition or disposal of Rx-Only and Controlled Substance medications within How many working days of a request by the board?
4 working days
The board may require a pharmacist who has NOT practiced pharmacy for over one year to serve not more then how many hours before the pharmacist may resume the active practice of pharmacy
400 hrs
Biennial fee for a Pharmacy permit, and Limited service pharmacy permit
480
How long must you document CE statements of credit and/or certificates?
5 years
Term length for pharmacists, techs, and public members of Arizona State Board of Pharmacy
5 yrs Public members: 5 yrs, unless removed by governor
All applications fees for everyone is how much
50
issuance of a Wall license/replacement Wall license for pharmacists, interns, technicians/tech-trainees are subject to a fee of how much
50
Biennial fee for a Drug wholesaler or manufacture permit; Nonprescription drug wholesaler
500
How long can a person be a pharmacy intern?
6 years Must provide explanation to the board as to why you need longer
Combat Methamphetamine Epidemic Act of 2005 Maximum amount monthly obtained by mail
7.5 grams/month
Initial/Renewal licensure fee for pharmacy technician
72
Federal Controlled Substance Act Limits for OTC controlled substance sales
8 oz (240 mL) of opium containing liquid 4 oz (120 mL) of controlled substance containing liquid 48 dosage units of opium-containing solid drug product 24 dosage units of controlled substance other than opium
Limits of methamphetamine precursors a person can buy in a MONTH?
9 grams/30 days
Combat Methamphetamine Epidemic Act of 2005 Monthly purchase limits
9 grams/month
What is the longest a correctional pharmacy can go without a pharmacist on duty?
96 hours
Limited-service nuclear pharmacies Equipment requirements (ARRA = Arizona Radiation Regulatory Agency)
ARRA-approved Fume hood LAFH Dose calibrator Refrigerator Class A prescription balance or electronic balance of equal or greater accuracy Well scintillation counter Incubator oven Microscope Various labels Glassware required by the ARRA Other equipment and supplies required by ARRA Current antidote and drug interaction information Regional Poison control ph # all over pharmacy
REMS Program iPLEDGE Isotrentinoin Brand names
Absorbica Accutane Amnesteem Claravis Myorisan Sotret Zenatane
What is the term for the following: If it is a drug or device to which any substance has been mixed or packed there with so as to reduce its quality or strength, or to be substituted for it in whole or in part
Adulteration
What is the term to describe the following :If the drugs container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health
Adulteration
What is the term to describe the following: Drug bears or contains a color additive that is unsafe or is a color additive with the intended use of which in or on drugs is for the purpose of coloring only and is unsafe within the meaning of the federal act
Adulteration
What is the term to describe the following: Drug or device produced, prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or is not securely protected from dust, dirt, and, as far as may be necessary by all reasonable means, from all foreign or injurious contamination, or whereby it may have been rendered injurious to health
Adulteration
What is the term to describe the following: Drug or device that consists in whole or in part of any filthy, putrid or decomposed substance
Adulteration
What is the term to describe the following: If it is a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium, unless stated on label
Adulteration
What is the term to describe the following: If the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug or device meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality, which it is represented to possess
Adulteration
What is the term to describe the following: strength differs from, or its purity or quality falls below that which it purports or is represented to possess
Adulteration
Long-term care facility pharmacy services automated dispensing systems When can a drug be dispensed from automated dispensing system
After pharmacist reviews and verifies Rx order
What shall be included when a pharmacy advertises for replacement soft contact lenses
All charges associated with purchase of replacement lenses
Correctional pharmacy Ensure the following apply with a pharmacist is out of the pharmacy and pharmacy techs remain to perform their duties:
All controlled substances are locked away All worked performed by techs immediately reviewed when pharmacist returns Drugs that have not been verified by pharmacist cannot be dispense while pharmacist absent
Two options for management of patient's home medication used in hospital
Allow patient-owned drugs to be administered: pharmacist/practitioner must very ID of drug and order must be written to give home medication Do not allow patient-owned drugs to be administered: pharmacy must package, seal, and give the drug to an agent of the patient for removal from the hospital OR return the drug to the patient at the time of discharge
E-prescribing of controlled substances
Allowed for C-II through C-V transmitted electronically from practitioner to pharmacy
Federal Controlled Substance Act, Does it allow e-prescribing of controlled substances
Allows C-II through C-V Prescriber and pharmacy use e-prescription software that meets DEA requirements
Drug Addiction Treatment Act of 2000 What does it allow?
Allows prescribers waiver to prescribed C-III to C-V for treatment of opioid addiction outside of registered narcotic treatment facility Does NOT allow prescribing of C-II for addiction
What 3 C-II depressants are categorized as C-III when part of a Compound, Mixture, or Suppository
Amobarbital Pentobarbital Secobarbital
When REFILLING a prescription for Soft Contact Lenses that is w/in 60 days of expiring, how much of the Rx can be refilled?
Amount needed to get to expiration date
Phenylpropanolamine is a precursor to what illegal drug
Amphetamine
What application must be submitted to relocate a business that has a non-prescription drug permit?
Application For Relocation
DEA Form 363
Application for DEA registration for narcotic treatment facility
DEA form 224
Apply for a DEA registration number
What approval is required prior to the dispensing of an investigational drug
Approval of medical staff committee of the hospital
What info is needed when prescription is delivered and pharmacist is not present
Approved uses Potential side effects Potential drug interactions Action to take in event of missed dose Phone # of dispensing pharmacy
Limited-service nuclear pharmacies Regulatory compliance
Arizona Radiation Regulatory Agency US Nuclear Regulatory Commission
What agencies must a manufacturer of radiopharmaceuticals be required to comply with?
Arizona Radiation Regulatory Agency US Nuclear Regulatory Commission FDA
What license are also required for entities that manufacture radoopharmaceuticals
Arizona Radiation Regulatory Agency Radioactive Materials License
Continuous quality assurance programs must be:
Assembled in manualMade available for employee reference or Board inspection Reviewed, and if necessary, changed/updated every 2 years
Medicaid Tamper-resistant Rx Requirement What 3 security features are required
At least 1 feature to prevent unauthorized copying (e.g. word "VOID or ILLEGAL" in background w/photocopied) At least 1 feature to prevent erasure or modification of information written by prescriber (e.g. checkboxes for Qty/refill authorization or background ink that shows erasures) At least 1 feature to prevent use of counterfeit Rx forms (e.g. serial #'s or logos printed on Rx paper)
Sterile compounding: Minimum space requirement
At least 100 sqft of contiguous floor area *If permit issued before 11/1/2006, then min is 60 sqft
Federal Controlled Substance Act Record keeping requirements
At least 18 years old Purchase must furnish ID Pharmacy records: Name/address of purchaser, name/quantity of product, date of sale, name/initials of pharmacist
Federal Controlled Substance Act How long should controlled substance records be kept?
At least 2 years
How long must logs for mechanical storage and counting device for restocking cells/cassettes be maintained?
At least 2 years
Federal Controlled Substance Act Records of distribution and receipt of controlled substances must be kept for how long?
At least 2 years DEA Form 222 for C-II Invoices for C-III to C-V
Minimum space requirement for compounding and dispensing counter in community setting
At least 3 sqft of space per working licensee counter top space must be at least 16 in. deep and 24 in . length For each additional employee an additional 3 sqft of pharmacy counter area is required
Controlled substance inventory record requirements Maintenance duration
At least 3 years
How long must non-prescription drug permittees keep records of receipt and disposal?
At least 3 years
How long must records be maintained that document controlled substances are received, sold, delivered, or disposed?
At least 3 years
How long must records that document manufacturing, repackaging, or relabeling of controlled substances?
At least 3 years
How long should invoices be kept on both the donor and prescription drug donation program side?
At least 3 years
How many hours per week must a hospital pharmacy provide services?
At least 40 hours/week and a pharmacist must be present in hospital at all times when pharmacy is open, except in extreme emergencies *Requirement may be reduced with written permission from board
Hospital pharmacy minimum space requirement
At least 500 square feet dedicated to preparation and dispensing functions *Applies to pharmacies issued permits after 1/31/2003
How long must compounding records be maintained?
At least 7 years
How long should the Original prescription order of drugs, devices or replacement soft contact lenses that are compounded or dispensed at the pharmacy be kept on file?
At least 7 years
How long must both the original and the transferred Rx order be kept on pharmacy records
At least 7 years after last dispensing date
How long must immunization records must be kept in pharmacy
At least 7 years from date of immunization
Procedures to close pharmacy: How long should Rx records and patient profiles be kept?
At least 7 years from the date and last original or refill prescription was dispensed
Procedures for closing a pharmacy: How long should drug and medical device purchase and disbursement records be kept?
At lest 3 years after the pharmacy is discontinued
What are the exceptions to no one being permitted in pharmacy when pharmacist is absent?
Authorized nurse supervisor following procedures to remove drug for immediate need of patient Only 1 pharmacist is on duty and must leave for an emergency; interns and techs can remain in pharmacy as long as all C-II drugs are locked up and pharmacist available at hospital
Correctional pharmacy Absence of pharmacist
Authorized personnel must have access to remote drug storage areas
Prescription Drug Marketing Act of 1987 (PMDA)
Banned selling, purchasing, trading of Rx DRUG SAMPLES
Limited-service nuclear pharmacies Supervision requirement of authorized nuclear pharmacist
Be present when open for business Supervise all personnel performing tasks to prepare and distribute radiopharmaceuticals and ancillary products
Determination of therapeutic equivalence from generic to brand product
Begin withe letter A, which are referred to as "A-rated generics"
DEA Number for practitioners with a waiver to prescribe buprenorphine for treatment of opioid addiction outside narcotic treatment facility
Begins with X
Board shall require and provide for ____ ____of every pharmacy, wholesaler/manufacturer, or another other place that sells drugs, compounds, dispenses, stocks, exposes, manufactured or offered for sale?
Biennial registration
Definition of emergency license restriction or suspension
Board can suspend license immediately with reason to believe three to public health, welfare, and safety
When can shared services be utilized?
Both pharmacies are owned by the same person/entity Or Enter into contract or written agreement outlining responsibilities
How fast should discrepancies be reported between the pharmacy and the wholesaler?
By the next business day
Scheduling of diphenoxylate
C-II alone C-V limited quantities in combination w/Atropine (Lomotil)
Scheduling of Codeine
C-II when used alone C-III when low doses in a combination w/APAP (Tylenol #3) C-V when low dose in combination w/Guaifenesin (Robitussin)
What is the scheduling of all anabolic steroids
C-III
What is the scheduling of all benzodiazepines
C-IV
Long-Term Care Facility Pharmacy Services Must provide what type of drugs
Routine, emergency drugs, and biologics Can obtain from provider pharmacy
Correctional pharmacy Facility and equipment requirements
Same as community pharmacy
What information is needed on dispensing log in ED when dispensing to patient because pharmacy is unavailable?
Same as prescription Patient's name/address Drug name, strength, and dosage form Quantity Directions for use Practitioner's signature or ID code DEA# for controlled substances
Correctional pharmacy Minimum space requirement
Same as retail pharmacy 300 square feet + 60 feet per person working at one time > 3 people Counter space at least 3 square feeing/licensee working at one time Separate patient counseling area
Long-term care facility pharmacy services automated dispensing systems Label requirements
Same info as required for drugs stored in emergency drug supply Plus Resident's room # and facility ID #
Long-Term Care Facility Pharmacy Services Storage of C-II
Separately locked, permanently affixed compartments, unless facility stores small quantity of controlled substances in single unit package drug distribution systems and missing doses can be detected readily
FDA recalls Class 1 Recall Definition
Serious adverse health effects up to and including death
What are the rules regarding supervisor of a pharmacists in a hospital with LESS than 50 beds?
Services of pharmacist required on a part-time basis... Approval of this does not permit compounding, manufacturing, dispensing, labeling, packaging or processing of drugs by other than a pharmacist
How long are prescriptions valid for with soft contact lenses?
Shorter of the two: 1) Date provided by provider/optometrist 2) One year after date of issuance
Arizona state board of pharmacy consists of what type of members?
Six pharmacists (at least one hospital pharmacist and retail pharmacist) One pharmacy tech Two public members
Combat Methamphetamine Epidemic Act of 2005 Pharmacy Storage Requirement
Solid dosage forms (including GEL caps) that contain pseudoephedrine, ephedrine, or phenylpropanolamine are to be stored behind counter or in locked cabinet away from customers
Combat Methamphetamine Epidemic Act of 2005 Manufacturer Packaging Requirement
Solid dosage forms that contain pseudoephedrine, ephedrine, or phenylpropanolamine must be package in blister packs
What must a student do with intern license if they stop attending pharmacy school?
Stop working as an intern Surrender intern license to Board within 30 days after last attending class
Federal Controlled Substance Act Maintenance of Controlled Substance Rx Records C-III to C-V
Stored either separate from all other records OR Marked with letter "C" at least 1 inch high in lower right corner
Federal Controlled Substance Act Controlled Substance Storage and Security
Stored in locked cabinet OR Dispersed among non-controlled stock to deter theft of diversion
ADULTERATED is when there's a problem(s) with the PRODUCTS, such as the...
Strength Quality Purity
Federal Controlled Substance Act Disposal of controlled substance inventory Process with Special Agent in Charge at local DEA office
Submit DEA Form 41 to Special Agent in Charge Wait to receive disposal instructions
What must be done when a drug wholesaler permittee relocates?
Submit new application "No application fee" required Issuance of permit for new location is contingent upon passing final inspection conducted by board compliance officer
What is required when a change in any officers of a corporation is done with a drug wholesaler permittee?
Submit new application No fee/inspection needed
What must drug manufacturer permittees do when relocating?
Submit new application to Board prior to relocation "No application fee" needed Issuance of permit for new location is contingent upon passing final inspection conducted by compliance officer
Who can obtain drugs in the absence of a pharmacist in a hospital?
Supervisory registered nurse Must be ordered by medical practitioner for Emergencies only, according to procedures recommended and approved by the board for each hospital
What to do with license if pharmacy closes down
Surrender license to executive director, Remove all drug signs and symbols Destroy all drugs, devices & poisonous/hazardous substances
What happens when you fail to renew your license on November 1?
Suspension of license Suspension is lifted once all past due fees and penalties are paid
Additional information required on Rx label in addition to normal requirements
Symbol, statement, or abbreviation that indicates product was compounded BUD
Preceptor responsibilities
Teach/mentor intern Review pharmacy policies and procedures Take responsibilities for actions of intern Provide opportunities for skill development and feedback on progress
Correctional pharmacy What needs to be arranged for prior to having no pharmacist on duty
Telephone access to pharmacist
Long-term care facility pharmacy services and emergency drugs Storage requirements
Temp controlled area Mechanism that prevents access by unauthorized personnel
FDA recalls Class 2 Recall Definition
Temporary or medically reversible adverse health effects
Narrow therapeutic index drug LD50
The dose that is lethal in 50% of the population
Narrow therapeutic index drug ED50
The dose that produces the desired effect in 50% of the population
Drug Quality and Security Act 2013 Outsourcing facilities must register with what governing body and comply with what type of practices
These are large-scale compounding facilities Must Register with FDA & Comply with cGMP
Duties of a pharmacy intern
They can perform the duties of a pharmacist only in the presence and under immediate personal supervision of a pharmacist
T.I.P.S REMS What doe it stand for?
Tikosyn in Pharmacy System Dofetilide
Long-term care facility pharmacy services automated dispensing systems Ongoing quality assurance program must include and how long maintained
Training for use Maintenance and calibration Accuracy validation testing once Q3mos System downtime and malfunction procedures Maintained for 2 years
What must be documented/performed to ensure accuracy of mechanical storage and counting device?
Training in Maintenance & Calibration & Use Routine quality assurance Accuracy validation testing
Pharmacy facility requirements
Trash cans emptied throughout the day Toilet facilities within 100 feet walking distance of pharmacy area Sink with hot and cold water Pharmacy personnel and apparel must be clean No animals, except licensed assistance and guard animals Free or insects/rodents Supply of chemicals to meet demands
Dietary supplements State law and requirements apply to dietary supplements that are labeled or marketed for...
Treatment of a disease Correction of symptoms of a disease Prevention, mitigation, or cure of any disease
Durham-Humphrey Amendment 1951
Two categories: OTC and Rx-only (legend drugs) Legend drug Labels must state "Caution: Federal law prohibits dispensing without a prescription"
Interchangeable biological product definition
US FDA has licensed and determined meets safety standards for determining interchangeability....... Determined to be therapeutically equivalent
Customized patient medication packages What standards must a pharmacist adhere to when doing this?
USP standards
Define the following according to Arizona law: Claiming the performance of services that were not actually performed
Unethical practices
Define the following according to Arizona law: Compensating medical practitioners or facilities in exchange for referrals or prescriptions
Unethical practices
Define the following according to Arizona law: Providing practitioners with RX pads/blanks that display or identify the pharmacist's or pharmacies name, address etc..
Unethical practices
Define the following according to Arizona law: Selling Rx-only drugs/devices without valid prescription
Unethical practices
Define the following according to Arizona law: Dispensing Rx-only drugs or devices pursuant to a diagnosis made via the mail or internet
Unethical practices Some exceptions in medical emergencies (p.32**)
Long-term care facility pharmacy services and emergency drugs Tamper-evident seal
Units are required to have tamper-evident seal or something similar
FDA recalls Class 3 Recall Definition
Unlikely to cause adverse health effects
Federal Controlled Substance Act # of Refills Allowed C-III to C-IV
Up to 5 refills
How long should original and transferred prescription orders be kept on file at respective pharmacies?
Up to 7 years from the date of last dispensing
Thalidomid REMS (formerly known as S.T.E.P.S)
Use in multiple myeloma/erythema nodosum leprosum Severe birth defects Mitigate risks by: Ensure patients are not pregnant when starting drug Preventing pregnancy while on drug
Federal Controlled Substance Act Distributing or receiving controlled substance inventory C-III to C-V
Use invoice to document transaction
Storage requirements of controlled substances in community pharmacy setting
Use of two methods: In locked cabinet or safe Dispersed throughout the pharmacy's stock of Rx-only drugs
Health Insurance and Portability & Accountability Act Privacy Rule
Use/disclosure of PHI to the minimum necessary Option for patient to obtain copy of health record and request corrections
Federal Controlled Substance Act Acceptable controlled substance Rx formats C-II Emergency Prescriptions
Verbal orders permitted
Duties of a hospital pharmacist or a pharmacy intern/graduate under supervision
Verify med orders for therapeutic and pharmaceutical feasibility Measure, count, poor, compound, admix, combine, or prepare package drugs for dispensing Verify task are performed correctly, safe, accurate results when performed by tech Supervise drug re-packaging and do final check Supervise aseptic technique, drug incompatibility training and education Consult with medical practitioners on drug therapy Patient consultations Monitor drug therapy for safe/effective outcomes Manage pharmacy personnel and systems Verify accuracy of orders Ensure compliance with hospital pharmacy's quality assurance program
What must a drug wholesaler do in order to complete a cash-and-carry sale?
Verify the following: Order is valid Person picking up order represents the person/entity that placed order Sale is to meet immediate needs of person/entity who placed orders (Rx only drug orders)
Veterinary drug distribution Prescription-ONLY veterinary drugs: who can drug manufacturers or suppliers distribute these to?
Veterinarians Full-service drug wholesalers Pharmacies
Veterinary drug distribution Non-prescription veterinary drugs: who can drug manufacturers or supplies distribute these to?
Veterinarians Full-service drug wholesalers Pharmacies Non-prescription drug retailers
When can a pharmacist give the FIRST dose for the primary adolescent series?
When at least 6 yrs old but under 13 years of age, w/a prescription order from provider
Correctional pharmacy Barrier requirement
When closed: enclosed by permanent floor or counter to ceiling or roof barrier/partition and locked doors Barrier to prevent unauthorized access during business hours at least 66 inches high
Limited-service mail-order pharmacy Barrier requirement
When closed: enclosed by permanent floor or counter to ceiling or roof barrier/partition and locked doors Barrier to prevent unauthorized access during business hours at least 66 inches high
Limited-service nuclear pharmacies Barrier requirement
When closed: enclosed by permanent floor or counter to ceiling or roof barrier/partition and locked doors Barrier to prevent unauthorized access during business hours at least 66 inches high
When can a second emergency state refill be given?
When emergency continues for longer than 21 days after first emergency refill was issued
Documentation requirements of oral consultations
Whether oral consultation was provided or not Name, initials, or other ID code of pharmacist/intern Circumstances oral consultation not provided
How many days do you have to alert the executive director of a new home address or employer address
Within 10 business days
How many days must a completed permit application w/fee be submitted with change of ownership on Non-prescription permit?
Within 14 days in change of ownership or change in stock ownership of 30% or more
How quickly must a drug pedigree be provided to the Board in response to a inspection?
Within 2 business days
How long do you have to submit CE credits/certificates if the Board request proof of CE credits?
Within 20 days
How quickly should access be given to a Board compliance officer if board request access to non-prescription drug vending machines?
Within 24 hours
Once a pharmacist returns to the pharmacy, how long do they have to verify the drug removal records?
Within 4 hours of returning from absence
How much time does a drug manufacturer need to be requested records available to the Board?
Within 48 hours
Long-term care facility pharmacy services and emergency drug Rx orders When should drug Rx orders be reviewed by a pharmacist after the first dose is administered?
Within 72 hours
How fast must you retrieve records to the Board when performing shared services
Within 72 hours upon request
Federal Controlled Substance Act Acceptable controlled substance Rx formats C-III to C-IV
Written Verbal Faxed Electronic
Federal Controlled Substance Act Acceptable controlled substance Rx formats C-V
Written Verbal Faxed Electronic OTC
Medicaid Tamper-resistant Rx Requirement
Written OUT-pt Rx billed to medicaid must be written on tamper-resistant paper to reduce fraud
Procedures for closing/discontinuing a pharmacy: Notice requirements and timing
Written notice to Board AND DEA (should include date of closure) Must be done at least 14 days prior to closing
Federal Controlled Substance Act Acceptable controlled substance Rx formats C-II
Written or electronic Some exceptions to this
Exceptions to the CE requirement
Year a licensee graduates Board can make exceptions based on written requests due to emergency, hardship case, or for good cause If board grants exception, must pass Board-approved exam to obtain renewal
Are licensees subject to repercussions by not reporting unprofessional conduct, incompetence or physical/mental instability to Board
Yes
Are solid dosage forms compounded by pharmacist exempt from imprint requirement
Yes
Can pharmacies advertise compounding services
Yes
Can there be a small slot/opening to accept new Rx orders or refill requests when pharmacist not present?
Yes
Can you dispense a generic product if the provider fails to mark the prescription as DAW?
Yes
Does disciplinary action taken by another state's board of pharmacy involving shared service required notification to Arizona Board?
Yes
Federal Controlled Substance Act Can an agent of prescriber fax controlled substance Rx to pharmacy?
Yes As long as prescriber manually signs prior to faxing
Can a pharmacist compound excess of the quantity to be dispensed in anticipation of valid Rx for the product?
Yes But must have established prescribing pattern prior to this
Federal Controlled Substance Act Can you fill C-II prescription if sent via fax to pharmacy?
Yes Can be filled, but not dispensed until patient presents original Rx and pharmacist has compared faxed Rx to original Rx
Can you modify the packaging of a drug in the official compendium?
Yes Method of packaging may be modified with consent of board
Can you e-prescribe controlled substances?
Yes Must comply with federal law
Can non-prescription drugs be sold while the pharmacy area is closed?
Yes Must hold a non-prescription drug permit
Can oral consultation be omitted and why?
Yes Professional judgement Must provide written information that would normally be discussed Contact info for pharmacist or intern Documentation of circumstances for not consulting orally
Are drugs and devices that are to be processed, labeled or repacked at establishments other than those where originally processed or packed exempt from any labeling or packaging requirements?
Yes Provided that they are delivered, manufactured, processed, labeled, repacked or otherwise held in compliance with board rules or under the federal act.
Customized patient medication packages Can pharmacist dispense these to patient
Yes With consent from patient, caregiver, prescriber, of facility
Can a copy of a prescription order be given to patient or agent of patient?
Yes, Must display statement........ "COPY FOR REFERENCE PURPOSES ONLY"
Are imprint codes required? For what types of drugs?
Yes, Required for all legend drugs that are capsules or tablets Can request exemption to Board if solid dosage form has unique characteristic
Can pharmacy technicians assist the pharmacist in compounding prescriptions and sterile or non-sterile pharmaceuticals?
Yes, but... Must complete a pharmacy tech drug compounding training program
Is there a designated space for patient counseling requirement in community setting?
Yes, must be separate and distinct for privacy
Can a pharmacist dispense NALOXONE HCL or any other opioid antagonists approved by US-FDA to a person or family member to a person that is at risk of experiencing an opioid-related overdose without a prescription?
Yes.
Is a new application needed when there is change in any officers of a corporation that has drug manufacturer permit?
Yes. Application fee and inspection not required
Can a pharmacy keep written logs of methamphetamine precursor purchase information on paper?
Yes. Doesn't have access to internet, Can have alternative electronic sales record keeping
Can authority be delegated to get medications from pharmacy when pharmacist is absent in emergencies?
Yes. In emergencies only can the supervisory nurse delegate to floor nurse, otherwise only supervisory nurse it allowed access
Can interns get credit for intern hours obtained outside of Arizona?
Yes. Must mee Arizona's minimum requirements
Can prescriptions be filled if the patient faxes in Rx?
Yes. Must present original Rx prior to dispensing medication
Can pharmacy interns give vaccines?
Yes. Only under immediate supervision of a pharmacist who is certified
Can emergency C-II Rx be issued?
Yes. Oral Rx order given directly to pharmacist from practitioner
Can you fill a order from a provider that is licensed in another country?
Yes. As long as the provider is licensed by an appropriate licensing board of a foreign country.
Are pharmacies required to submit Methamphetamine precursor purchase information to National Database?
Yes. If the system is available to retailers without a charge for access
Can pharmacists/pharm tech receive CE at their own presentation
Yes. Must follow same procedure as audience to get credit
Consists of filthy, putrid, or decomposed substances is the definition of what type of drug products or devices
adulterated
Not produced, prepared, packed, or stored in accordance with good manufacturing practices is the definition of what type of drug products or devices
adulterated
Produced, prepared, packed, or stored under unsanitary conditions is the definition of what type of drug products or devices
adulterated
The container is made of a substance that could render the contents injurious to health is the definition of what type of drug products or devices
adulterated
The product contains a coloring agent that has been deemed unsafe is the definition of what type of drug products or devices
adulterated
The strength differs from, or the quality or purity falls below, that which is stated on the label is the definition of what type of drug products or devices
adulterated
Permittees stocking 30 different Non-prescription drug products or LESS shall be categorized as what category retailer
category 1 retailer
Permittees stocking MORE than 30 different Nonprescription drug products shall be classified as what category retailer
category 2 retailer
When ordering schedule II controlled substances for your pharmacy, What must you do with the first two pages (Brown & Green) of the DEA Form 222
give them to the supplier w/out separating them. For the form to be valid the Brown & Green copies must be intact w/the carbon paper b/t them. Pharmacy must retain the third page (Blue copy) of the form for record keeping purposes
How can a pharmacy meet the qualifications for the quality assurance programs?
if it holds a current general, special or rural hospital licensed from department of health in the following: 1) Certified to participate in the medicare/medicaid 2) Accredited by joint commission on the accreditation of health care organizations 3) Accredited by the American Osteopathic Association
What type of Drug Wholesaler permittee does not require a Pedigree?
non-prescription drug wholesalers
Access to product storage areas for Drug wholesaler permittees must be restricted to whom?
personnel only
What 2 people are responsible for ensuring all Pharmacy Personnel comply with laws/rules
pharmacy Owner & Manager
Who is Exempt from requiring a non-prescription drug permit
practitioners
Traditional Pharmacies, Outsourcing Facilities and Manufacturing Facilities are regulated by...
state board of pharmacy
T/F An Intern must hold a valid pharmacy intern licensure and obtain all hours through the experiential training program of a board approved pharmacy school/college
t
t/f Certificate fees of Annual inspection fees calculated at the average hourly rate of a pharmacy inspector multiplied by the duration of the inspection measured in 10 minute increments or proprtion of a 10 min increment
t
t/f Full Service Wholesale distributors must maintain the Pedigree and a copy of the license or permit of each person/entity with which they do business
t
A pharmacy permittee must notify the Board "immediately" of change or pending change in the person acting as the PIC within how many hours?
w/in 24hrs
What certifications must be provided for a pharmacist to renew immunization certificate?
CPR certification 5 CE hours on topics related to immunization
The goal of the _____ is to prevent illicit drug use and distribution while allowing for legitimate medical use, this law is AKA the "Comprehensive Drug Abuse Prevention and Control Act"
CSA
What is the main requirement of a electronic tracking system for methamphetamine precursor transactions?
Can generate stop sale alert notification that would result in violation quantity limits, Can override alert notification if fear of bodily harm if drug not sold, Must log each time a person overrides system
Can drugs be returned to cell/cassette in mechanical storage and counting device when drugs has been counted, but not left the pharmacy?
Can only be returned using a Board-approved method that implements technology to prevent drug return error
When does a C-II Rx expire?
Cannot be filled more than 90 days(3 mos) after the date issued
Refill limit for C-II Rx
Cannot be refilled
When do prescriptions expire
Cannot be refilled more than 1 year after date written
Computer records: What are the electronic record keeping requirements for prescription files?
Capture exact image of Rx (including back if necessary) Include notes, clarifications, alterations that are associated with image Store image and notes for at least 7 years from date of last dispensing Original hardcopy must be kept for at least 30 days after the date dispensed
Controlled substance inventory record requirements Additional inventory requirements for full-service drug wholesaler
Change in ownership Discontinuation of business Within 10 days of change in PIC or designated representative
When must a new application/fee be submitted for changes in ownership
Changes in stock ownership of 30% or more, the prospective owner must submit a new application w/fee at least 14 days prior to change in ownership
Disciplinary actions the Board can take
Civil penalty ($1,000 per violation) Letter of reprimand Decree of censure Board-approved CE courses Probation Suspension
Requirements for equipment and utensils in compounding
Clean Non-porous Compatible with ingredients Equipment calibrated routinely
What are the floor requirements near the working space of the counter (where employees stand) in community setting?
Clear and continuous for at least 36 inches from any counter, fixture or structure
Clozaril National Registry
Clozapine Indication: psychiatric disorders Potential fatal agranulocytosis Mitigates risk by: Requiring WBC to be recorded to registry on weekly basis for first 6 months and periodically thereafter Limit drug prescribed by pharmacies to dispense sufficient only to treat patient till their next scheduled lab work (7 day supply Qwk x 1st 6mos)
What REMS Program is referred to as the "No Blood, No Drug Program"
Clozaril National Registry
Elements that could be included in oral consultation
Common severe side effects, interactions, contraindications Self-monitoring techniques Duration of therapy Refill info
Federal Controlled Substance Act C-II Emergency Prescriptions Verbal Order Process
Communicated directly from prescriber to pharmacist Immediate reduce verbal Rx to writing Reasonable effort to verify validity of unknown prescriber Qty limited to amt adequate tx pt during emergency Prescriber must deliver written hard copy to pharmacy within 7 days Hardcopy prescription should be attached to verbal order and filed
What are the steps to renew pharmacist and pharmacy tech licenses
Complete "Application for License Renewal" Pay renewal fee Fulfill the CE requirement
Label must contain the following when compounded product is made in excess and stored in pharmacy
Complete list of ingredients (or name of final product) Date prepared Lot # assigned by pharmacy BUD assigned by pharamcy
Investigational drugs What information must be available regarding an investigational drug?
Composition Pharmacology Adverse reactions Administration guidelines ALL other info concerning the drug
Federal Laws Where does compounding vs manufacturing take place
Compounding: Registered pharmacy under supervision of pharmacist Manufacturing: Registered drug manufacturing facility
Long-term care consultant pharmacists Who to notify if irregularities and dispensing errors are found
Consultant pharmacist to notify prescriber, direct of nursing at the facility, and provider pharmacy
Correctional pharmacy Remote drug storage areas must have the following
Contain properly labeled drugs that may be needed and administered safely without pharmacist Be accessible only with written order Provide a written record of each drug removed Be inventoried at least once weekly audited once a month for compliance
Poison Prevention Packaging Act of 1970 Child resistant packages definition
Containers 'significantly difficult' for children under 5 years old to open, but not difficult for adults
Pharmacy permittee or PIC of pharmacy with automated storage and distribution systems that allow access by patient must ensure the following:
Contains Rx that don't require counseling (Refills) Contains Rx properly labeled and check by pharmacist Allows patient to choose whether or not to use system Located within wall of pharmacy or secured to wall or floor within 20 ft of pharmacy Has mechanism to ID patient and release only Rx for that patient Provides option for pt to receive counseling if requested Does not allow refills to dispense if pharmacist deems oral counseling is necessary
Long-term care facility pharmacy services and emergency drugs Content and use requirements
Contents of the emergency drug supply unit must remain the property of the provider pharmacy Unit must only contain drugs to address immediate emergency medical needs Unit should only be accessed during emergencies
How often should pharmacist participate in quality assurance programs?
Continuous
Drugs not acceptable to prescription drug donation programs
Controlled substances Drug samples Drugs that can only be dispensed to patients registered with manufacturer Expired drugs Drugs that expire within 6 months of donation Adulterated drugs
Long-term care consultant pharmacists Controlled substance storage
Controlled substances must be stored separate from other medications in locked, permanently affixed compartment Unless facility uses a single-unit package medication distribution system with accurate records of administration/ultimate disposition
Types of limited-service pharmacies
Correctional pharmacies Mail-order pharmacies Long-term care pharmacies Sterile pharmaceutical products pharmacies Nuclear pharmacies
Food and Drug Administration Modernization Act 1997 (FDAMA)
Could shorten "Caution: Federal law prohibits dispensing with a prescription" to "Rx only."
Federal Laws Definition of compounding
Creation of personalized, patient-specific medication Cannot be copy of commercially available FDA approved product (exception = shortage) Cannot contain ingredients that are unsafe or ineffective Can only be made in response to patient-specific Rx or in anticipation of Rx order if an established prescribing pattern exists
Long-term care consultant pharmacists Requirements and responsibilities
Current Arizona License Provide pharmaceutical care services Review/assist facility to develop policies and procedures for drug/device storage and distribution Using CMS indicators, provide eval programs to monitor therapeutic response and utilization of all drugs Provide pharmacy education services within facility Participate in quality management of resident care in facility Communicate with the provider pharmacy to resolve problems and concerns
Limited-service nuclear pharmacies Authorized nuclear pharmacist eligibility requirements
Current pharmacist license AND Board of Pharmaceutical Specialities certification as a nuclear pharmacist or all of following: 200 hours of didactic training and meeting min training requirements for status as authorized user of radioactive material as specified by Arizona Radiation Regulatory Agency and US nuclear Regulatory commission, complete 500 hours of clinical training under supervision, certify in writing the above training was complete
OTC Controlled Substance Dispensing Requirements
Customer at least 18 years old ID required from every unknown purchaser Must be for legitimate medical purpose Dispensed by pharmacist, pharmacy intern, or grad intern (Interns must be supervised by pharmacist)
Who is responsible for enforcing the CSA
DEA
Who to report controlled substance loss reporting requirements
DEA Narcotic Division of the Department of Public Safety (DPS) Arizona State Board of Pharmacy
Who needs to be notified when Rx files are being stored in a pharmacy computer system?
DEA and Board Responsibility of pharmacy permittee or PIC
What document must be used in transaction of C-I and C-II drugs
DEA form 222
Federal Controlled Substance Act Distributing or receiving controlled substance inventory C-II
DEA form 222 to document transaction OR CSOS is electronic form of DEA form 222
What are the record keeping requirements for when a business manufactures, re-packages, or re-labels a product
Date of manufacturing, repackaging, or relabeling must be recorded AND kept on file for 3 years
Limited-service nuclear pharmacies Prescription order requirements in addition to regular requirements
Date/time radiopharmaceutical was calibrated Name of procedure for which radiopharmaceutical is prescribed Words "Physician Use Only" rather than the patient's name if the product is a non-therapeutic or non-blood product
Limited-service nuclear pharmacies LEAD Container used to store & transport radiopharmaceutical shall have a LABEL that, in addition to the requirements includes
Date/time radiopharmaceutical was calibrated Name of radiopharmaceutical Molybdenum 99 content to USP limits Name of procedure for which radiopharmaceutical is prescribed Words "Physician Use Only" instead of patient's name if the product is a non-therapeutic or non-blood product Words "CAUTION: Radioactive Metal" Standard radiation symbol
Limited-service nuclear pharmacies Labeling requirements for radiopharmaceutical Container
Date/time the radiopharmaceutical was calibrated Pt name recorded before dispensing, if therapeutic or for blood product Words "Physician Use Only" rather than the patient's name if the product is a non-therapeutic or non-blood product Name of radiopharmaceutical Dose Serial number Words "CAUTION: RADIOACTIVE MATERIAL" Standard radiation symbol
Sterile compounding area must have the following characteristics
Dedicated to preparing/compounding sterile products Isolated from other functions Restricted entry or access Free from air flow disturbances Non-porous and cleanable floor, wall and ceiling ISO Class 7 environment: not required if compounding occurs in ISO class 5 isolator
True or False Brand name narrow therapeutic index drug should not be substituted with generic drug
Depends Pharmacist must use professional judgement combined with regulatory knowledge in any generic substitution decision
What is required to obtain a full service wholesaler permit?
Designated representative must be identified
Federal Controlled Substance Act Disposal of controlled substance inventory methods
Destroy on-site in presence of DEA agent or authorized person Deliver to reverse distributor For returns/recalls, deliver to source from which obtained Request assistance from the Special Agent in Charge at local DEA office
Equipment requirements for sterile compounding
Devices that maintain and ISO Class 5 Waste containers for needles, syringes, and other waste Freezer storage w/thermostatic control & thermometer Packaging or delivery containers for required drug storage conditions Infusion devices and accessories Current reference for compounding sterile drug products
Dietary Supplement Health and Education Act 1994 (DSHEA)
Dietary supplements classified as foods Manufacturers an market dietary supplements without FDA review FDA must be able to prove lack of safety to take product off the market, whereas drug products must prove safety before entering market
Who is responsible for the security of a hospital pharmacy?
Direct of pharmacy
In hospital pharmacy who is responsible for Handling and distributing investigation drugs
Director of pharmacy
In hospital pharmacy who is responsible for consuming with personnel and medical staff committees to develop a formulary
Director of pharmacy
In hospital pharmacy who is responsible for regular inspections of drug storage and preparation areas
Director of pharmacy
In hospital pharmacy who is responsible for safe and efficient procurement, dispensing, distribution, administration, and control of drugs
Director of pharmacy
In hospital pharmacy, who must develop and implement procedures for secure distribution and control of Rx order blanks bearing identification of the hospital?
Director of pharmacy
In hospital pharmacy, who must develop and implement procedures for operation of a drug distribution system that optimized patient safety
Director of pharmacy May be developed and implemented by PIC
Who is in charge to ensure necessary information regarding investigational drugs are made known?
Director of pharmacy or PIC
Who is responsible for development, implementation, and compliance with policies and procedures regarding drug sample in hospital?
Director of pharmacy or PIC
What can the board do after investigating a situation where there is not sufficient seriousness to merit disciplinary action?
Dismiss the complaint without merit, File an advisory letter. Licensee can file written response within 30 days, Require licensee to complete board designated CE courses
Federal Law Practitioners with FULL prescribing authority Dentists
Doctor of Dental Medicine (DMD) Doctor of Dental Surgery (DDS)
Federal Law Practitioners with FULL prescribing authority Physicians
Doctor of Medicine (MD) Doctor of Osteopathic Medicine (DO)
Federal Law Practitioners with LIMITED prescribing authority Optometrist
Doctor of Optometry (OD)
Federal Law Practitioners with FULL prescribing authority Podiatrists
Doctor of Podiatric Medicine (DPM)
Federal Law Practitioners with FULL prescribing authority Veterinarians
Doctor of Veterinary Medicine (DVM)
Federal Controlled Substance Act Disposal of controlled substance inventory Process with returns or recalls
Document with DEA Form 222
Federal Controlled Substance Act Disposal of controlled substance inventory Process with reverse distributor
Document with DEA Form 222
What is a cash-and-carry sale?
Drug Wholesaler buyer pays for order up front and makes their own transportation arrangements
When can a DRUG be returned after being sold/dispensed and leaves pharmacy?
Drug is unopened and in the manufacturer's original container AND otherwise protected from contamination and deterioration
Hospital prescription label requirements: single unit packages
Drug name, strength, and dosage form Lot # BUD Auxiliary labels
Hospital prescription label requirements: Re-packaged preparations
Drug name, strength, and dosage form Lot # BUD Auxiliary labels Mechanism to ID the pharmacist responsible for packaging
Long-term care facility pharmacy services and emergency drugs Label requirements of emergency drug supply unit
Drug name, strength, dosage form Manufacturer, lot #, expiration date Pharmacy's name, address, and phone # Pharmacist's initials
Drugs exempt from controlled substance Rx monitoring program requirements
Drug samples Drugs administered directly to patient Drugs issued through narcotic treatment programs Drugs dispensed in limited quantities by practitioner within health care facilities (No more than 72 hour supply and not more than twice within 15 days)
What must happen prior to dispensing drugs and drug storage in hospital pharmacy
Drugs must be stored in locked area under pharmacist control
What policies and procedures must take place if ED dispensing takes place when pharmacy is unable to do so?
Drugs only dispensed to ED patients Drugs only dispensed by authorized medical practitioner Drugs meeting immediate need of patient Dispensed quantities are limited until outpatient pharmacy services are available Drugs are pre-packaged by a pharmacist or under supervision Pharmacy maintains a dispensing log, hardcopy Rx, or electronic record
When can a pharmacist provide a one-time 30 day refill without prescription?
During a state of emergency
Prescription transfer document requests: What must be recorded with CONTROLLED SUBSTANCE prescriptions
Each pharmacy's DEA number
Limited-service mail-order pharmacy Controlled substance storage requirements
Either locked in cabinet/safe OR Dispersed throughout Rx-only drug stock in a manner to deter theft/diversion
Physical barrier requirements in community setting
Enclosed by permanent partition/barrier Barrier must extend from floor or counter to ceiling or roof Openings in barrier not large enough to allow removal of items from pharmacy area While open: barrier at least 66 inches high to protect pharmacy from unauthorized access Doors to pharmacy must be securely locking
Federal: FDA Roles
Enforces drug manufacturing laws Regulates large-scale compounding facilities also known as outsourcing facilities Oversee Rx drug advertising (Direct-to-consumer advertising)
Federal OSHA Roles
Enforces occupational health and safety laws
Federal DEA roles
Enforces the federal Controlled Substances Act (CSA) Categorizes drugs with potential for abuse, addiction and dependence intro controlled substances schedules
Pharmacy intern licensing requirements
Enrolled & in good standing in board-approved pharmacy school and provide One of the following: --Official transcript --Letter from dean --Letter from registrar
Responsibilities of PIC in community pharmacy
Ensuring prepration, implementation, and compliance with pharmacy policies and procedures Reviewing/modifying policies and procedures every 2 years Assembling policies/procedures into written or electronic manual Making manual available to pharmacy personnel and Board inpsection
Federal Controlled Substance Act Biennial Inventory
Entire controlled substance inventory must be counted at least once every 2 years
Renewal period for pharmacist immunizations certificates
Every 5 years
How often must cleanrooms (ISO class 7) and laminar flow hoods must be certified
Every 6 months
What is the schedule to renew a license for a pharmacy?
Every two years Odd numbered license: on odd years Even numbered license: on even years
Federal Controlled Substance Act Disposal of controlled substance inventory in institutional setting
Example: Waste in pre-filled syringe Does NOT need to be recorded on DEA Form 41
How are people nominated to the Arizona State Board of Pharmacy?
Executive director of pharmacy association of Arizona submits names to governor; governor can go with list of names or some other candidate that fits requirements
Federal Controlled Substance Act Expiration date of Rx C-III to C-IV
Expiates 6 months after date written
When should soon to be expired products be moved to the quarantined area?
Expiration date is with 120 days of expiring
Exception to access by pharmacists only to additional storage areas outside of pharmacy area in community setting
Extreme emergencies that constitutes imminent threat to pharmacy personnel or patrons
Outsourcing Facilities and Manufacturing Facilities are regulated by...
FDA
FDA Amendments Act of 2007
FDA can require MFG to comply w/ programs that help manage the risks associated with the use of certain drugs, referred to as Risk Evaluation & Mitigation Strategies
FEDERAL LAWS
FEDERAL LAWS
MISBRANDED is when there's a problem(s) with the LABELING, such as...
False information Misleading information Insufficient information
Resource for generic substitution
Federal Orange Book, the official title is "Approved Drug Products with Therapeutic Equivalence Evaluations"
Record keeping requirements for C-II Rx orders
Filed separate from other Rx records
What is the requirement the Board has and needs to obtain for a full service wholesale permittee for a background check?
Fingerprints
Pure Food and Drug Act 1906
First Federal law to regulate drug products Addressed purity of products Did NOT address safety or false claims
DEA form 222 Who retains various pages
First page "original" (brown): retained by drug supplier Second page (green): Forwarded to DEA by drug supplier Third page (blue): Retained by pharmacy
When can a DEVICE be returned for exchange for resale?
Free of defects Incapable of transferring disease If resoled or refused, not claimed to be new or unused
Wholesale Distributors that distribute drugs within, into, or from Arizona must obtain what permit to do so?
Full service wholesale permit
Pharmacy technician trainee license qualifications
Good moral character At least 18 yrs old High school diploma or equivalent
Pharmacy technician license qualifications
Good moral character At least 18 yrs old High school diploma or equivalent Completed training program Pass pharmacy tech exam
Graduate intern licensing requirements
Graduate of a board-approved pharmacy school, submit an application for pharmacist licensure by examination or reciprocity AND Provide one of following: --Final transcripts with graduation date --Letter from dean --Letter from registrar NOTE: Licensed pharmacy interns should NOT apply for a separate graduate intern license after graduation. The graduate intern license is reserved for pharmacists who are required by the board to complete intern hours
Computer records: What two methods must be used to document the accuracy of original and refill prescription information?
Hardcopy printout of daily original and refill prescription data Logbook or separate file of daily statements Both must have the following: Statement that data is reviewed by pharmacist for accuracy, printed name of each dispensing pharmacist, signed and initialed by each dispensing pharmacist
Health Insurance and Portability & Accountability Act When Minimum necessary use and disclosure does not apply
Healthcare provider for treatment Patient upon request Authorized by the patient Necessary to comply with other laws Department of Health and Human Services for compliance investigation, review, or enforcement
Limited-service nuclear pharmacies Radiopharmaceutical must only be transferred to other persons/entities that hold
Hold current Radioactive Materials license issued by Arizona Radiation Regulatory Agency
Federal Controlled Substance Act C-II Faxed Prescriptions can Serve as Original Rx in what 3 cases?
Hospice patients Home infusion patients Long-term care facility residents
Documentation for each compounded drug product must include
ID of ingredients (manufacturer, lot #, exp date) Order in which ingredients were combined and how compounded Equipment, utensils, and containers/lids used Maintain records for at least 7 years
DEA Number Verification 1st Letter
ID's type of practitioner/registrant A, B, or F for physicians, dentists, veterinarians, hospitals, and pharmacies M for midlevel practitioners P or R for manufacturers, distributors, researchers, and narcotic treatment programs
Difference between brand and generic drugs?
Identity of manufacturer Composition of inactive ingredients (e.g. fillers, binders & color additives)
Record keeping requirements whenever a product (controlled substance, Rx only drug/device, non-prescription drug, precursor or regulated chemical) is sold, delivered, or deposed of?
Identity of product, identity of person on each end of transaction, date of transaction AND kept on file for 3 years
On-call pharmacist and hospital pharmacy requirements
If hospital is open less than 24 hours/day Pharmacist must be on call to provide consultation, DI services, and to review or dispense orders during the time the pharmacy is closed
Long-term care facility pharmacy services and emergency drugs Record keeping requirements
If the unit is automated, an electronic record of access must be maintained for at least 2 years
What Written WARNING is required when dispensing Soft Contact Lenses?
If you are having any unexplained eye discomfort, watering, vision change or redness, remove your lenses immediately and consult your eye care practitioner before wearing your lenses again
What is the notification period for a PIC when they start or terminate in that position?
Immediately to the executive director
Controlled substance inventory record requirements
Include exact count of all C-II Include exact count for all C-III through C-V in containers that hold more than 1001 dosage units or estimate for all C-III through C-V in containers that hold equal to or less than 1000 dosage units Date and if inventory was taken before opening or after the close of business PIC signs Maintain separate from other records
T.I.P.S REMS "Tikosyn In The Pharmacy System"
Indication: A-fib or atrial flutter Potential fatal ventricular arrhythmias, especially when starting Mitigates risk by: Communicating risk of ventricular arrhythmia's associated w/ Tikosyn (dofetilide) Requiring patients starting or restarting dofetilide to be admitted to hospital for at least 3 days
When can the Board release information called by controlled substance Rx monitoring program?
Individual requesting own information Prescriber or dispenser (or deleted healthcare professional) for evaluation of patient To medical regulatory board, law enforcement, criminal justice agency, county medical examiner, forensic pathologist, or the Arizona Health Care Cost Containment System) for open investigation/complaint To a person servicing a lawful court order Entities for statistical, research, or educational use, but only after removing PHI
Who can donate drugs to prescription drug donation programs
Individual: through practitioner, pharmacy, or health care institution Manufacturer Health care institution
What must interns report to board when performing intern hours outside of curriculum?
Initiating employment Terminating employment Changing training sites
Exceptions to misbranding rules
Intended for the use in pharmaceutical compounding by a licensed pharmacist, physician, drug manufacturer or distributor or registered outsourcing facility in compliance with the requirements of chapter 18 of this title and the food, drug and cosmetic act...... Mislabeled or incorrectly filled because of a filling error by a pharmacy or a pharmacist
Federal Controlled Substance Act Process when drug is newly scheduled or change in schedule of a drug
Inventory is required on the day the scheduling or change in scheduling takes effect
REMS Program iPLEDGE
Isotrentinoin, effective Tx for severe acne Severe birth defects Ensure patients are not pregnant when starting drug Preventing pregnancy while on drug
Labeling of cell or cassette requirements for mechanical storage and counting device
Label affixed to front that displays: Name of drug Strength
Long-term care facility pharmacy services automated dispensing systems Controlled substance inventory
Legally-required controlled substance inventories must include controlled substances stored in automated dispensing system and emergency drug supply units
Narrow therapeutic index drug Definition
Less than 2-fold difference between median lethal dose (LD50) and median effective dose (ED50) Or Less than 2-fold difference between the minimum toxic concentration (MTC) and the minimum effective concentration (MEC)
Renewal period for pharmacists and technicians
License ends in odd number: Biennially on November 1 of odd numbered yrs License ends in even number: Biennially on November 1 of even numbered yrs
Controlled substance Rx monitoring program registration requirements
Licensed medical practitioners that possess DEA registration Pharmacists: complete training course and request access from controlled substance Rx monitoring program director
Qualifications to be on Arizona State Board of pharmacy for pharmacists
Licensed pharmacist for 10 yrs Pharmacists/resident of Arizona 5 yrs prior to appointment Public Members must be state resident for 5 yrs prior to appointment
Rules regarding the display of license or permit in pharmacy
Licensee shall maintain licensee's current renewal license or duplicate which must be displayed conspicuously/visually in pharmacy
Federal Controlled Substance Act C-II Emergency Prescriptions Verbal Order Quantity Limits
Limited to amount to adequately treat patient during emergency period No specific quantity limits
Long-Term Care Facility Pharmacy Services Storage of drugs
Locked, temperature controlled compartments Authorized personnel can have access
Federal Controlled Substance Act Controlled Substance Partial Refills C-II Exception to Partial Fill Rule
Long-term care patients Terminally ill patients Multiple partial refills permitted for up to 60 days from date written
What happens if a pharmacist fails to notify board within 7 days that an emergency C-II Rx was not received?
Lose their authority to dispense emergency C-II Rx pursuant to oral order
Federal Laws Two major differences between compounders vs manufacturers
Manufacturers must comply with cGMP Manufacturers must obtain permit and register with FDA prior to commencing operation
DEA Number Verification 2nd Letter
Matches first letter of prescriber's last name or the first letter of the business name
Long-term care consultant pharmacists makes arrangements with what 3 people when the pharmacy is not open, to provide an emergency drug supply unit within the facility so nursing staff can have access to emergency meds when provider pharmacy is closed
Medical staff Director of nursing PIC
Pseudoephedrine/Ephedrine are precursors to what illegal drug?
Methamphetamine
What happens when a Poisonous/Hazardous substance is identified by its packaging as being a food, drug or cosmetic container
Misbranded
What is the term for the following: A legally-required word or statement is not displayed on the label or in the labeling of drugs or devices
Misbranded
What is the term for the following: A product for human use that contains a certain habit forming substance (e.g. narcotic or hypnotic) without indicating the name or quantity of said substance on the label of the drug or device
Misbranded
What is the term for the following: Drug labeling is false or misleading
Misbranded
What is the term for the following: Drug or device that contains any quantity of the NARCOTIC or HYPNOTIC substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote or sulfonmethane, or any chemical derivative of such substance, which derivative or other substance has been found to be habit-forming, unless its label bears the name and quantity or proportion of such substance or derivative"
Misbranded
What is the term for the following: Drug that is recognized in the official compendium that is not packaged and labeled according to the compendium
Misbranded
What is the term for the following: Drug/device is imitation of another drug/device
Misbranded
What is the term for the following: Drugs with a label that does not identify the established name and quantity of the active ingredients (e.g. if contained alcohol)
Misbranded
What is the term for the following: For prescription-only/controlled substances the manufacturer, packer, or distributor does not include all advertisements/other printed material with respect to that drug a true statement of: Established name Formula showing quantitatively each ingredient Other info: side effects, contraindications, effectiveness
Misbranded
What is the term for the following: For prescription-only/controlled substances, if in final dosage form form unless it bears the following: Name/place of business of manufacturer (and if different the packer/distributor) Accurate statement of quantity of the contents in terms of weight, measure or numerical count
Misbranded
What is the term for the following: Foreign dangerous drug not approved by FDA Does not apply to areas where state laws allow use or under federal, drug and cosmetic act Does not apply to shortages with temporary approval
Misbranded
What is the term for the following: If a trademark, trade name or other identifying mark, imprint or device of another drug or device or any likeness of another drug or device has been placed on the drug or device or on its container with intent to defraud.
Misbranded
What is the term for the following: If it has been found by the board to be a drug or device liable to deterioration, unless it is packaged in that form and manner, and its label bears a statement of such precautions, as the rules issued by the board require as necessary for the protection of public health
Misbranded
What is the term for the following: If it is a color additive, the intended use of which in or on drugs or devices is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive in the federal act or board rule"
Misbranded
What is the term for the following: If it is a drug label, to the exclusion of any other nonproprietary name, does not have the the following: Established name of drug (if there is one) Established name of quantity of each ingredient
Misbranded
What is the term for the following: If it is dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labeling of the drug or device"
Misbranded
What is the term for the following: If it is offered for sale under the name of another drug or device
Misbranded
What is the term for the following: If it's Container is so made, formed or filled as to be misleading
Misbranded
What is the term for the following: Label does not bear the following: Adequate directions for use Adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in a manner and form as are necessary for the protection of users
Misbranded
What is the term for the following: Label of Drug or Device does not accurately state quantity of contents in terms of weight, measure, or numerical count"
Misbranded
What is the term for the following: Label of Drug or device does not identify the name and location of either the MFG, packer, or distributor
Misbranded
What is the term for the following: Labeling does not include adequate directions for use and adequate warnings
Misbranded
What is the term for the following: Per ARS-32-1968, a prescription only drug that fails to bear the statement "RX-Only" at any time prior to dispensing
Misbranded
What is the term for the following: The product is an imitation of another drug device
Misbranded
What is the term for the following: The product is dangerous to health if used as prescribed, recommended, or suggested in the labeling
Misbranded
What is the term for the following: The product is offered for sell under the name of another drug or device
Misbranded
What is the term for when a drug label does not bear, "Rx only," and is a prescription only product?
Misbranding
Dulera REMS
Mometasone/formoterol Indication: Asthma Manufacturer must communicate to provider increased risk of asthma-related death with LABA use
Long-Term Care Facility Pharmacy Services What monthly service must a pharmacist provide for each resident?
Monthly drug regimen reviews
What are the rules regarding supervision by a pharmacist in a hospital with 50 beds or MORE?
Must be continually under supervision of a pharmacist during operating hours. Board may make exceptions to pharmacists engaged in hospital business outside of pharmacy
Record keeping requirements for controlled substance dispensed OTC
Must be documented with each C-V purchase Name/address of purchaser Name/quantity of controlled substance Date of purchase Name or initials of pharmacist/intern
Federal Controlled Substance Act Initial inventory requirements
Must be done when a pharmacy first opens for business
Hospital pharmacy physical barrier requirement
Must be enclosed by permanent partition/barrier from floor to ceiling Equipped with locking doors
What record keeping is required when filling prescriptions from a provider that is from another country?
Must be filled separately from other prescriptions
Procedures to close pharmacy: State permits and certificates
Must be returned to Board of Pharmacy
Requirement to review orders prior to administration in hospital pharmacy
Must be reviewed by pharmacist prior to initial dose administered *Does not apply to emergency medical situations or when pharmacy closed
Federal Controlled Substance Act Maintenance of Controlled Substance Rx Records C-II
Must be separate from all other records
What are the requirements for drugs to be used in prescription drug donation programs
Must be unopened in original sealed, tamper-evidence packaging (including unit dose meds as long as innermost packaging is intact) Can be dispensed by physician offices, pharmacies, and hospitals
What must be done when a PIC is replaced in regards to inventory?
Must complete a controlled substance inventory within 10 days of change
Long-Term Care Facility Pharmacy Services Pharmacist employment rules
Must employ (or obtain from provider pharmacy) a pharmacist for consultation, record keeping, and monthly drug reviews for each resident
Limited-service nuclear pharmacies Permit requirements
Must employ authorized nuclear pharmacist with current Radioactive Materials license issued by Arizona Radiation Regulatory Agency
Limited-service nuclear pharmacies Qualifications of PIC
Must employ authorized nuclear pharmacist with current Radioactive Materials license issued by Arizona Radiation Regulatory Agency
What are the requirements for hospital pharmacies to have an exemption for labeling and oral notification requirements?
Must have a formulary to which all medical practitioners of the hospital have agreed and that is available for inspection by the board
What are identification badge requirements for pharmacists and interns?
Must have an ID badge that indicates...Name and Position/Title while on duty
Minimum space requirement for pharmacy area in community setting
Must have at least 300 square feet to accommodate up to 3 employees Additional 60 square feet for each additional employee working at same time
Limited-service nuclear pharmacies Reference Library Requirements (ARRA = Arizona Radiation Regulatory Agency)
Must have following: ARS 30-651 through 695 pertaining to ARRA ARRA rules FDA regulations pertaining to radioactive drugs Arizona Pharmacy Practice Act and Rules Arizona Uniform Controlled Substances Act Radiological Health Handbook
Quality assurance program requirement for pharmacies with any automated storage and distribution system
Must have ongoing quality assurance program in place
Long-term care facility pharmacy services and emergency drugs Policies and procedures
Must include at least once weekly exchange or restocking of the unit to ensure adequate supply
What must non-resident permittees (mfg, wholesaler, retailers & pharmacies) have a copy of when selling/distributing drugs in Arizona?
Must keep copy of current permit or license of individual/entity acquiring drug NOTE: Does NOT apply for non-resident pharmacies dispensing drugs to patient with valid prescription
Prescription record requirements
Must maintain file/book of every Rx order Must be serially numbered, dated, and filed in order dispensed or compounded Can use electronic filing
What must be done in regards to telling patients about shared services prior to putting into practice?
Must notify patient Rx could be processed or filled by another pharmacy Notification can be made via one-time written notice to pt or a sign in the pharmacy
What must be done prior to relocating a non-prescription drug vending machine?
Must notify the Board
Long-term care facility pharmacy services automated dispensing systems Controlled substance and registration requirements
Must obtain separate controlled substance registration for each location with an automated dispensing system containing controlled substances Copy must be kept at the provider pharmacy for Board inspection
How do non-resident pharmacies qualify for license in Arizona?
Must possess equivalent license or permit in state/jurisdiction where they reside
Procedures to close pharmacy: DEA documents
Must return DEA registration certificate Must returned unused DEA 222 forms to DEA regional office in PHX
When doing shared services, what considerations must you consider in regards to technology?
Must share technology that allows access to information required to perform the shared service
Arizona's controlled substance inventory requirement
Must take inventory of C-II though C-V substances each year on May 1 or as directed by Board
A pharmacist may be required to do what if they have not practiced for more than a year?
My have to complete 400 hours of internship prior to resuming active practice
Federal Controlled Substance Act # of Refills Allowed C-II
NOT permitted
What information is required on label when an ingredient is transferred from its original container to a different container
Name of ingredient Manufacturer or supplier name Lot # or control # Weight or volume BUD Transfer date
What additional requirements does a CONTROLLED substance prescription need in addition to regular requirements?
Name, address, and DEA # of prescriber
What Transaction Information is contained in a Pedigree
Name, address, phone # & email of each owner of the Rx-Only drug & each wholesaler that handles the drug
What documentation is needed whenever providing shared services?
Name, initials, or ID code of person that took part in each step of processing Rx
Label requirements for controlled substances dispensed OTC from pharmacy
Name/address of dispensing practitioner or pharmacist Serial number Date dispensed Name of prescriber Name of patient (Name of owner/species) Directions for use Caution statements from Rx order or by law For C-II through C-IV: Caution: federal law prohibits the transfer of this drug...
Required elements of oral consultation
Name/strength of medication Indication Directions for use Route of administration Special instructions Written information: side effects, procedures for missed doses, storage
Federal Laws What treatment facilities are the only ones that can dispense C-II (methadone) for treatment of opioid addiction?
Narcotic treatment facilities
Correctional pharmacy When can a nurse supervisor get drugs from the pharmacy when pharmacist is not present?
Need a drug to meet immediate need of patient and not available in remote drug storage area
What situations required oral counseling?
New Rx New strength, dosage form, or directions Pharmacist determines consolation warranted Patient or caregiver request oral consultation
Poison Prevention Packaging Act of 1970 Exceptions to child-resistant packaging requirement
Nitroglycerin SL tabs Steroid dose packs Aerosols Birth control pills Female hormone replacement drugs
Can B-rated products be dispensed as generic equivalents in Arizona?
No
Can documents from pharmacy quality assurance programs by subpoenaed in a civil proceeding?
No
Can donated drugs be resold?
No
Can multiple medications be prescribed on a C-II prescription form?
No
Can pharmacy tech trainees assist in compounding
No
Can you get CE credit for a class taught at pharmacy school that are not CE courses?
No
Combat Methamphetamine Epidemic Act of 2005 Limits when drugs obtain by Rx
No
Federal Controlled Substance Act Are drug samples exempt from inventory requirements?
No
Federal Controlled Substance Act Can controlled substances be mailed/shipped out of country?
No
Federal Controlled Substance Act Is post-dating of controlled substances allowed
No
Hospice inpatient facilities Can automated dispensing systems be utilized by pharmacy
No
Is formulary development required with limited-service long-term care pharmacy?
No
Is patient notification required regarding shared services in facilities such as hospitals
No
Long-term care facility pharmacy services automated dispensing systems Can you stored C-II in automated dispensing system?
No
DEA form 222 Can mistakes be corrected
No All copies must be voided and retained by the pharmacy
Can wholesaler permittees repackage or re-label products
No All products must remain as originally packaged and labeled by MFG or Re-packager
Can a C-II prescription be stored as an electronic image only?
No Must keep hardcopy or make one and store for at least 7 years
Can patients self-administer medications in hospital?
No Unless ordered by medical practitioner AND patient educated/trained on proper administration
Federal Controlled Substance Act Expiration date of Rx C-II
No expiration
Federal Controlled Substance Act Expiration date of Rx C-V
No expiration
Pharmacist to intern ratio limit in Board-approved school/college of pharmacy experiential training program
No limit
How often can a non-controlled substance Rx be transferred?
No limitations
Federal Controlled Substance Act # of Refills Allowed C-V
No maximum
Maximum number of intern hours that can be obtained at an alternative training site (non-pharmacy training site)?
No more than 500 hours
What is the longest a hospital pharmacy can be without a pharmacist
No more than 72 consecutive hours
Can you fill CONTROLLED substance prescriptions from a provider that is licensed in another country?
No.
Are non-resident pharmacies required to employ a PIC with Arizona license?
No. As of 2015
Can pharmacies compounding products for other pharmacies, practitioners, or distribution?
No. Exception: Compounding for a practitioner to administer to his/her patients
Federal Controlled Substance Act Can any prescriber write for controlled substances?
No. Must be legitimate medical purpose in practitioner's course of practice
Can substitutions be made when dispensing soft contact lenses prescription
No. Must dispense what is written for
Non-prescription drug permits: Can permittees sell non-prescription drugs in different packaging?
No. Must sell non-prescription drugs in manufacturer's original packaging
MFG, Wholesale Distributors & pharmacies that are NOT located in Arizona, yet wish to conduct business in Arizona (i.e. sell, distribute, and/or dispense drugs) must obtain what type of permit?
Non-Resident Permit
Federal Controlled Substance Act Limits on number of dosage units of a controlled substance that can be authorized by a Rx at one time?
None
Assisted living facilities Automated dispensing systems
Not allowed
Assisted living facilities Use of emergency drug supply units
Not allowed
How many days in advance can you apply for license renewal
Not more than 60 days
Federal Controlled Substance Act Transferring Controlled Substance Rx Orders for Refill C-II
Not permitted
DEA Number for Federal Government Practitioner
Not required to register with DEA, unless work in private practice They indicate branch of service or the agency in which they serve and their service ID number (e.g Army 123-45-6789)
Procedures for closing a pharmacy: What must the notice indicate as far as drugs, transaction records, Rx-files and patient profiles
Notice must indicate the location to which the drugs, transaction records, prescription files, and patient profiles will be sold, kept or transferred
Hospice inpatient facilities Who is responsible to replace or relabel drugs with damaged or soiled labels?
ONLY the pharmacist from Pharmacy that dispensed the medication
Federal Controlled Substance Act Renewal period for DEA registrations
Once every 3 years
Federal Controlled Substance Act Controlled Substance Partial Refills C-II
One partial fill permitted Remainder can be filled within 72 hours Remained is void if not filled with 72 hours and prescriber must be notified
OTC controlled substance medication limits
One person in 48 hours: 8 oz (240 mL) of opium containing liquid 4 oz (120 mL) of liquid that contains controlled substance other than opium 48 dosage units of opium containing product 24 dosage units of controlled substance other than opium
Federal Controlled Substance Act Transferring Controlled Substance Rx Orders for Refill C-III to C-V
One time transfer to another pharmacy Occurs between two pharmacists Unlimited transfers for pharmacies that share real-time, online database
How often can a controlled substance Rx be transferred?
One-time Unless both pharmacies share a real-time online database, then can be transferred without limitation
Long-term care facility pharmacy services and emergency drugs Personnel responsibilities
Only remove a drug from the unit after receiving a valid Rx order Notify provider pharmacy when a drug is removed from unit
DEA form 222a
Order additional supply of DEA 222 forms
DEA form 222
Ordering C-I and C-II controlled substances
Acceptable medication order formats in hospitals
Original written order (or direct copy) Faxed copy of the original written order Verbal order
Who is responsible to notify the board of pharmacy when a pharmacists or intern is terminated because professionally incompetent, unprofessional conduct,mentally/physically incompetent?
PIC Must submit general statement of the reasons that lead to termination
What information must be included in logs for mechanical storage and counting device for restocking cells/cassettes
Paper or electronic records Identity of cell or cassette by drug name & strength or cell/cassette # NDC # or MFG Exp date Lot # from stock bottle Date cell/cassette filled Identity of licensee filling cell/cassette Identity of supervising pharmacist
What must be done to reinstate an Arizona pharmacy license that has been delinquent for greater than 5 years while practicing in another state/jurisdiction
Pass Arizona MPJE Pay delinquent annual renewal fees and penalties
What must be done to reinstate an Arizona pharmacy license that has been delinquent for greater than 5 years WITHOUT practicing in another state/jurisdiction
Pass Arizona MPJE Pay delinquent annual renewal fees and penalties Appear before Board to demonstrate fitness to be licensed
Long-term care consultant pharmacists Access to information, what is needed
Patient profiles from the provider pharmacy Medication administration records from the long-term care facility Reports of suspected ADRs Inspection reports of drug storage areas (Exp drugs)
Poison Prevention Packaging Act of 1970 How to request an easy-open cap, referred to as "snap-cap"
Patient requests Prescriber can request on Rx
Federal Controlled Substance Act Required info for controlled substances Rx orders
Patient's full name and address Prescriber's full name and address Prescriber's DEA # Drug name, strength, dosage form Quantity prescribed Directions for use Date issued Prescriber's signature (Not required for verbal order)
Correctional pharmacy Information recorded by nurse when removing drugs from pharmacy in pharmacist absence
Patient's name Drug name, strength, and dosage form Dose prescribed Quantity removed Date and time of removal Nurse's signature or initials Medical order/copy must be attached to this record & placed conspicuously in pharmacy
Information that must be recorded by nurse when remove a drug from the pharmacy
Patient's name Drug name, strength, dosage form Quantity removed Date and time of removal Nurse's signature or initials Must attach to medication order AND place in a conspicuous place in pharmacy
Hospital prescription label requirements: IV admixture preparations
Patient's name and location Name and quantity of basic parenteral solution Name and amount of drug added Date prepared BUD date and time Administration guidelines Auxiliary labels and precautionary statements Initials of pharmacist responsible for preparation
Health Insurance and Portability & Accountability Act Breach Notification Rule
Patients must be notified if their PHI compromised
What is a document or electronic file that records each instance in which a product is distributed from the time it is obtained from the MFG until the time it is sold to a pharmacy or medical practitioner
Pedigree
How long should records be stored for OTC controlled substance purchases?
Per federal law, all controlled substance records must be maintained for 2 years
Controlled substance inventory record requirements Full-service drug wholesalers
Performed on May 1st each year
Federal Controlled Substance Act Disposal of controlled substance inventory Process with DEA agent or authorized person
Permission from DEA obtained in advance 2 employees of the DEA restraint must witness No specific method of destruction required Must be non-retrievable Document on DEA Form 41
Intern training site requirements
Permitted by Arizona board of pharmacy and employ a preceptor who supervises intern or Non-pharmacy related training sites that perform pharmacy-related activities (may or may not be monitored by school of pharmacy)
Federal Controlled Substance Act Controlled Substance Partial Refills C-III to C-V
Permitted with no time limit for completion, however Rx expire 6 months after date written
Omnibus Budget Reconciliation Act of 1990 Who does this law specifically apply to?
Pertains only to Medicaid patients Most states have expanded to apply to all patients
Federal Controlled Substance Act 5% Rule for Pharmacies
Pharmacies registered w/DEA may distribute a limited # of control substance dosages to other DEA-registered pharmacies or practitioners without registering as a distributor as long as the Limit is 5% of total number of controlled substance dosage units dispensed in 1 calendar year. DEA registered pharmacies or practitioner Must register as distributor if you go above 5%
What pharmacies may temporarily be established or relocated to a mobile/temporary pharmacy facilitiy
Pharmacies within a declared disaster area Non-resident pharmacies Pharmacies permitted/licensed in another state/jurisdiction, but not licensed in Arizona
Personnel allowed in pharmacy area in the community pharmacy
Pharmacist Graduate and pharmacy interns Pharm tech and trainees Support personnel Compliance officers Drug inspectors Peace officers Other designated and personnel and persons authorized by law
What are the qualifications to dispense in Arizona during a state of emergency whenthe pharmacist is licensed in another state?
Pharmacist has proof of license in another state Pharmacist engaged inrelief effort during emergency period
Documentation needed to emergency state refill
Pharmacist must make good faith effort to reduce Rx to a written Rx marked, "emergency-Rx" Keep with other prescription records
Omnibus Budget Reconciliation Act of 1990 (OBRA'90) Requirements
Pharmacist perform prospective DUR and offer counseling to medicaid patients Must provide "offer to counsel" for Medicaid patients (does not apply to in-pt setting) Pharmacists try to keep patient profiles up-to-date
Who can sell or dispense any drugs or to dispense or compound the prescription orders of a medical practitioner?
Pharmacist, Pharmacy Interns under the direct supervision of a pharmacist and Techs can dispense only if under the direction supervision of a pharmacist
Who can communicate Rx transfer by phone
Pharmacists Pharmacy interns Graduate interns
Who can transfer non-controlled substance Rx electronically
Pharmacists Pharmacy interns Graduate interns Pharmacy techs Pharmacy tech trainees under pharmacist supervision
Who can open a drug shipment in community setting?
Pharmacists Pharmacy personnel under supervision of pharmacist
Who can transfer schedule III and IV controlled substance prescriptions
Pharmacists only
Biennial renewal fees for pharmacists, tech, and duplicate renewal license
Pharmacists: 180 Technicians: 72 Duplicate: 25
Responsibilities of PIC of a mobile/temporary pharmacy facility
Pharmacy is under control and management of supervising PIC Pharmacy is in or adjacent to declare disaster area Board is notified of location of pharmacy Pharmacy is properly secured Pharmacy records kept in compliance with Arizona laws Pharmacy services STOP when state of emergency ends
Correctional pharmacies definition
Pharmacy located within a correctional facility
Long-term care facility pharmacy services automated dispensing systems Electronic Log
Pharmacy must provide log for each container filled or stocked by automated dispensing system; Log must include...........: -Container # -Drug name and strength -NDC # or MFG Manufacturer's lot # and exp date Date container was filled ID of licensee that filled container and ID of supervising pharmacist
What are the (9) classes of permits Arizona can give in regards to pharmacies and places that sell drugs?
Pharmacy permit Limited service pharmacy permit Full service wholesale drug permit Nonprescription wholesale drug permit Drug manufacturer's permit Drug Packager permit Drug Re-packager's permit CMG Distributor permit DME & CMG Supplier permit
Who reports intern hours to the board?
Pharmacy school: hours obtained through curriculum Student: Hours obtained outside of curriculum
Long-term care consultant pharmacists Who must identify, replace, or relabel drugs that illegible or missing labels
Pharmacy that dispensed the medication
Rx label requirements for compounding product when given directly to patient from practitioner's office
Pharmacy's name, address, phone # Name of compounded product and some indication that the product was compounded Lot # or control # BUD Following statements: "Not for dispensing" "For Office or Hospital Administration Only"
what information is required to submit to the board for the Controlled substance Rx monitoring program
Pharmacy's name, address, phone #, DEA # Patient's name, address, phone #, DOB Prescriber's name, address, phone #, DEA # Name, strength, quantity, dose, NDC # of control Date written/Date dispensed Whether Rx is new or a refill # of refills authorized by prescriber Method of payment
Provider pharmacies for long-term care facilities Rx label requirements
Pharmacy's name/address Serial number Date of dispensing Prescriber's name Patient's name Directions for use Cautionary statements Drug name, dosage form, and quantity BUD Controlled substances: "CAUTION: federal law prohibits the transfer..."
Assisted living facilities Rx Label requirements
Pharmacy's name/address Serial number Date of dispensing Prescriber's name Patient's name Directions for use Cautionary statements Drug name, strength, dosage form, and quantity BUD Controlled substances: "CAUTION: federal law prohibits the transfer..."
Hospice inpatient facilities Rx Label Requirements
Pharmacy's name/address Serial number Date of dispensing Prescriber's name Patient's name Directions for use Cautionary statements Drug name, strength, dosage form, and quantity BUD Controlled substances: "CAUTION: federal law prohibits the transfer..."
Medicaid Tamper-resistant Rx Requirement Exceptions, Prescriptions transmitted by:
Phone Fax E-prescription
Limited-service mail-order pharmacy phone number requirements
Phone # must be toll free and printed on label affixed to each dispensed container Pharmacist must be available at least 5 days/week and 40 hours/week
Limited-service sterile pharmaceutical products pharmacies phone number requirements
Phone # must be toll free and printed on label affixed to each dispensed container Pharmacist must be available at least 5 days/week and 40 hours/week
Federal Law Practitioners with LIMITED prescribing authority Midlevel Practitioners
Physician Assistant (PA) Nurse Practitioner (NP)
Qualifications for Arizona State Board of Pharmacy for technicians
Practice as tech for at least 5 yrs* Resident of Arizona for at least 5 yrs prior to appointment *Pharmacy tech prior to July 1, 2009 does not have to meet the minimum 5 yr requirement for licensure
Who must report required monitoring information to controlled substance Rx monitoring program
Practitioners Pharmacies Health care facilities If they prescribed C-II through C-IV
Federal Law Institutional DEA Numbers
Practitioners and residents can prescribe controlled substances using institution's DEA # Institution assign internal code to practitioner Practitioner append code to end of institution's DEA #
Federal Controlled Substance Act Who is required to get a DEA registration
Practitioners who prescribed controlled substances All entities involved in production and/or distribution of controlled substances
Drug Addiction Treatment Act of 2000 Changes in DEA Number
Practitioners will have second DEA # that begins with X
Limited-service nuclear pharmacies Four separate required areas in pharmacy for radiopharmaceuticals
Preparing and dispensing Receiving and shipping Storing Decaying radioactive waste
Federal Controlled Substance Act Who can perform a verbal order for controlled substances?
Prescriber to the pharmacist directly
REMS Program iPLEDGE Isotrentinoin Rx limits
Prescriptions are limited to a 30-day supply
Pharmacy permittee or PIC of pharmacy with automated storage and distribution systems that allow access only be licensed personnel must ensure the following:
Prevents unauthorized person from accessing drugs/devices Allows authorized licensed personnel access to fill, stock, or restock drugs/devices
Computer Records: What are the responsibilities of pharmacy permittee or PIC in preparing an dimple meting procedures for computer use in pharmacy
Procedures to follow when computer system not operational Procedures for routine backup of data Audit procedures Assignment of personnel codes Data entry quality assurance procedures
Combat Methamphetamine Epidemic Act of 2005 Record keeping requirements
Product name/quantity sold Name, address, and signature of purchaser Date at time of sale Maintained for 2 years
Hospital pharmacy equipment requirements
Profesional reference library Sink with hot and cold water (not in toilet facility) Refrigerator and freezer Designated area for a laminar airflow hood w/ supplies for preparing sterile drug products/ infusions Temp controls to maintain temp for proper drug storage
Adulterating or Misbranding a product is what type of act
Prohibited act
Creating or offering to create forged prescriptions is what type of act
Prohibited act
Destroying any part of a Label on a drug, device, poison, or hazardous substance that is offerred for sale is what type of act
Prohibited act
MFG, selling, holding, or offering for sale any counterfeit drug is what type of act
Prohibited act
MFG, selling, holding, or offering for sale any product that is Adulterated or Misbranded is what type of act
Prohibited act
Practicing pharmacy without a License is what type of act
Prohibited act
What must be done for a pharmacist that has not had active license for 5 consecutiveyears?
Proof of fitness to be licensed Payment of all pastdue fees and penalties
Who can drug wholesalers distribute drugs to
Properly licensed/permitted individuals and businesses... -Medical practitioners -Pharmacies -Non-prescription drug retailers
Long-term care facility pharmacy services automated dispensing systems Drug ownership
Property of the provider pharmacy
Who are responsible for the quality of drugs and devices sold or dispensed in a pharmacy?
Proprietor Manager PIC Exception: drugs sold in Original package by MFG
Health Insurance and Portability & Accountability Act Purpose
Protect PHI of patient medical records and health information
Health Insurance and Portability & Accountability Act Security Rule
Provides technical safeguards to protect PHI Outlines national standards for companies to protect PHI
Federal Anti-Tempering Act 1982
Reaction to Chicago Tylenol Murders OTC drug products must have tamper-evident seal
Kefauver Harris Amendement 1962
Reaction to thalidomide tragedy Manufacturers must provide evidence for SAFETY and EFFICACY
What must a patient sign if receiving drug from a drug donation program?
Recipient form to document receipt of a donation and immunity provisions of program
Long-term care facility pharmacy services automated dispensing systems Electronic record of access records and how long maintained
Record time and date each user accessed the system and removed drug Maintain for at least 2 years
What are the requirements for providing records to a Board inspection for full-service or non-prescription wholesalers?
Records on site: Available during regular business hours Off-site location: Available within 2 business days
What are the record keeping requirements for drug manufacturers?
Records regarding production, proces control, labeling, packaging, quality control, distribution, complaints Records needed for current GMP Must be kept for 2 years after drug distributed or 1 year after expiration date (whichever is longest)
Poison Prevention Packaging Act (PPPA) of 1970 Purpose
Reduce incident of death and serious injury caused by accidental ingestions of medications and other harmful household substances
Refill limit for C-V Rx
Refills may be filled within 1 year of issued date No official limits on # of refills issued
Refill limit for C-III and C-IV Rx
Refills may be filled within 6 months of issued date No more than 5 refills
Pharmacy equipment requirements
Refrigerators C-V controlled substance register, (if sold w/out an oreder of a medical practitioner) Graduates in various sizes Spatulas: various sizes, one non-metallic Mortar and pestle* Clas A Rx balance* or electronic balance One ointment tile or equivalent* Current copy of Arizona Pharmacy Act, administrative rules, and Arizona Controlled Substance Act Professional reference library: Pharmacology/toxicology, therapeutics, drug compatibility, drug product equivalency Various labels (Rx, Transfer, Caution/Warning) Stamp for letter "C" (if C-3,4,5 not filed separate) Current antidote and drug interaction info Poison control phone # displayed
C-I and C-II must be distributed only between what type of people/entities
Registered with DEA
Federal Federal Trade Commission Roles
Regulates the advertising of OTC drugs, medical devices, cosmetics, and food products
Shared services examples
Remote order entry Central fill pharmacies
Procedures to close pharmacy: Pharmacy signs and symbols
Remove from inside and outside of building
DEA form 224a
Renewing DEA registration (Every 3 years)
Food, Drug, and Cosmetic Act 1938 (FD&C ACT)
Replaced Pure Food & Drug Act 1906 and Required drug manufacturers to provide FDA with evidence of SAFETY with new drug application (NDA)
When must pharmacies report controlled substance Rx monitoring program requirements?
Report from previous week (Sunday through Saturday) electronically by close of business day on Friday If Friday is state holiday, then deadline moved to next business day
Long-Term Care Facility Pharmacy Services Reporting of irregularities from pharmacist
Report to physician and facility's director of nursing and these reports "must be acted upon" (@ minimum the pharmacist's recommendation must be acknowledge)
Controlled substance loss reporting requirements
Reported on DEA form 106 by PIC/permittee Must state if police investigated loss on 106 form Reported within 10 days of discovery Pharmacy must maintain a copy of form
DEA Form 41
Reporting destruction of controlled substances
DEA form 106
Reporting loss or theft of controlled substances
DEA form 104
Reporting pharmacy closure or surrender of pharmacy permit
Long-term care facility pharmacy services automated dispensing systems Barcode technology requirements
Required to ensure drugs are loaded accurately
What electronic record keeping system requirements are needed to waive requirements of stamping Red "C" on hard copy of prescription when filing in regards to storying C-III through C-V Rx orders?
Requirement waived for letter "C" in lower right hand corner... 1) Prescription permits ID by Rx# 2) Original records can be retrieved using -prescriber's name, -patient's name, -drug dispensed, -date filled
