MD MPJE
How is a sterile drug defined? (for outsourcing facilities)
"drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law."
What is a pedigree?
"invoice" for non-controlled substances
Pharmacy repositories may not charge more than a $____ dispensing fee
$10
BOP can fine pharmacists up to
$10,000
BOP can fine techs and interns up to
$2500
PDMP violation failure to report fee
$500 per failure
BOP can fine wholesale distributors up to
$500,000
Batch preparation of specific compounded sterile preparations is acceptable if
(1) Pharmacist can document a history of valid prescriptions or physician orders that have been generated solely within an established professional prescriber-patient-pharmacist relationship; and (2) Pharmacy maintains the prescription on file for such preparations dispensed.
How to document periodic review of medication delivery system to ID high-alter meds
(a) A list of high-alert medications present in the prescription area of the pharmacy; (b) The date that a high-alert medication was added to or removed from the list of high-alert medications; (c) Dates that the list was reviewed by the pharmacy permit holder; and (d) Remedial actions taken based on the review of the list of high-alert medications and any medication errors relating to the high-alert medications.
The labeling requirements for prescription drugs do not apply if the authorized prescriber dispenses the drug or device
(i) To an inpatient in a hospital or related institution; (ii) In an emergency situation; or (iii) As a sample drug or device dispensed in the regular course of the authorized prescriber's practice.
Surety bonds amounts for wholesale distributors
- $100,000 if the gross receipts of applicant are $10M or more - $50,000 if less than $10M
Pharmacy CE requirements
- 30 CE every 2 years - 1 CE in med error prevention - 2 live CEs - 4 CEs in immunization if registered to administer vaxes - 1 in contraception if able to prescribe
PA prescribing requirements
- A notice of intent to delegate prescribing of controlled dangerous substances, prescription drugs, or medical device - An attestation that all prescribing activities of the physician assistant will comply with applicable federal and State regulations - An attestation that all medical charts or records: (i) Will contain a notation of any prescriptions written by a physician assistant in accordance with this section (ii) will be reviewed and cosigned by supervising physician within a period reasonable and appropriate to the practice setting
Permit holder must report theft or significant loss of CDS to the following
- BOP - local police - OCSA - DEA (form 106) PERMIT HOLDER!! Report theft of non-CDS drugs or devices to Board only
A pharmacist in an infusion pharmacy service shall:
- Base infusion svcs. on orders by prescriber of record or protocols - Perform and document initial and ongoing assessments - Create a patient care plan - Comply w/ USP 797, if applicable - Assess lab values, if applicable - Verify label accuracy - Communicate w/ prescriber, infusion nurse, patient, caregiver - Review pain and nutrition status
Single dispensing of dosage unit does not apply to:
- CDS - First prescriptions or change in a prescription for a maintenance drug - for contraceptives, first 2-month supply of an initial Rx or any subsequent rx that is different than the prior contraceptive rx
Who should be notified of *significant* losses of CDS? Within how long?
- DEA - OSCA - local policy - BOP All of this must be done within 1 business day; you must also report theft of non-CDS to these people too
When dispensing outside a pharmacy, what are the acceptable locations? (4)
- DTM in doctor's office, clinic, or medical facility - public health facility - non-profit facility - health center at educational institution
When transferring a prescription, primary pharmacy must record the following for a NON-CDS (4)
- Date of transfer - Name of transferor - Name of transferee pharmacist - Name of secondary pharmacy
When transferring a prescription, primary pharmacy must record the following for a CDS (6)
- Date of transfer - Name of transferor - Name of transferee pharmacist - Name of secondary pharmacy - DEA registration of secondary pharmacy - "VOID" on original prescription if a hard copy
During a board inspection, what can the board inspect?
- Inspectors may inspect entire establishment area - Inspectors may inspect any required pharmacy records - Inspectors may take pictures - Pharmacy may not hinder or impede inspections
What are exceptions to depots? (5 locations)
- Licensed healthcare facilities (i.e. clinics) - Prescribers' offices - Prescription area of pharmacy - USP/common carrier - Multiple family residence (i.e. apartment receptionist desk)
Who can you disclose PHI to?
- Other HCPs for TPO purposes or to patient and/or pt's agent - Public health activities (e.g., to authorized health officers) • Judicial and administrative proceedings (requests should be made pursuant to a court or administrative order, or subpoena) • Law enforcement purposes (e.g., to law enforcement officers in certain circumstances) • Serious threats to health or safety (e.g., in suspected cases of abuse, neglect, or endangerment) • As required by law
Infusion pharmacy policies and procedures must address
- Personnel training - Infection control - Security - Home safety assessments - Patient/caregiver education - Pharmacist's checking procedures - Therapy monitoring - Pharmacist's on-call availability
Requirements for pharmacies returning non-CDS only
- Pharmacist must accept return (cannot delegate to tech) - Maintain separate secure container *behind prescription counter* - Dispose of returned drugs through appropriate returns processor or reverse distributor - Have policies and procedures re: safe and secure handling of returned drugs and supplies
How does the PDMA regulate prescription drug wholesale distributors?
- Requires the state to license them in the state where a wholesale distribution facility is located - Requires secondary wholesale prescription drug distributors (i.e., who do not have an ongoing business relationship with a manufacturer to distribute that manufacturer's drugs) to provide a statement of origin or drug "pedigree" as part of certain sales of drugs. - FDA enforced requirement that dispensers only accept ownership of a product if they receive product tracing information prior to or at time of transaction
Exceptions to informing a patient of availability of a generic product
- Rx is written for generic drug or interchangeable biologic - DAW - pharmacist works in a pharmacy that primarily serves public or private institutional patients (i.e. hospital or nursing home) - cost of RX is reimbursed by a third party payer (i.e. caremark, BCBS) Only time you would need to inform them is if they are paying cash
Responsibilities of director of pharmacy
- Supervise compounded preparations - Participate in development of formulary - Maintain accountability and control of pharmaceuticals -Maintain emergency drugs/antidotes in pharmacy/patient care areas -CDS inventory/dispensing
MD has incorporated the following documents by references for sterile compounding
- USP 797 - USP 795 - USP chapter 821 radioactivity - USP pharmadiopharmaceuticals for PET compounding
What is an outsourcing facility?
- a facility that is engaged in the compounding of sterile drugs - has elected to register as an outsourcing facility - complies with all of the requirements of section 503B
What equipment must a cleanroom contain?
- a laminar airflow workstation w/ ISO5 - waste containers approved by OSHA - ancillary supplies required for proper compounding
A person that prepares and distributes sterile compounded medications for *office use* into, out of, or within the State shall hold
- a manufacturer's permit or other permit designated by FDA to ensure the safety of sterile compounded meds for office use - a wholesale distributor permit, if applicable
Pharmacy establishment must have the following to ensure security
- alarm/security system - secured computer system - inventory management system - well-lit perimeter
Hatch-Waxman Act
- allowed FDA to approve generic versions of brand-named drugs - gave additional patent time to brand name manufacturers - allowed generic manu to work on their copies of brand name while the patent was still in force - provided the ANDA as mechanism for generic drug approval
Vaccines for ages 18 and older
- any vax - any vax cdc recommends for international travel (no rx needed)
Pharmaceutical specialties that require waiver permits
- assisted living facilities - comprehensive care facilities - developmental disability facilities - home infusion - inpatient hospital - non sterile compounding - sterile compounding - research - vet care - continuing care retirement community
Requirements to administer self-admin drugs
- attestation - active CPR certification through in-person classroom instruction - A licensed pharmacist may administer a self-administered drug in accordance with a prescription - intern can administer self-ad drugs under direct supervision of pharmacists who meets requirements
Who needs a controlled substance registration? (4)
- authorized prescribers registered to prescribe CS - individual practitioners who dispenses CS - a hospital - a pharmacy
Pharmacist qualifications requirements to administer vaccines (3)
- board-approved certification course re: CDC guidelines - active CPR certification through *IN PERSON* instruction - 4 CEs related to vaccinations
Opening inspection requirements for a pharmacy
- class A balance and weights or prescription balance if applicable - medication refrigerator w/ thermometer - hot & cold running water - pharmacy library w/ MD pharmacy laws - active security system - a pharmacist
If a pharmacist prescribes contraception, must meet what requirements?
- completion of a board-approved training program - notification of the board of completion of program - use of patient self-screening assessment form - use of a standard procedure contraceptive algorithm - make referral to primary care or repro health practitioner - provide visit summary - maintain records - 1 hr of CE in contraception per renewal period
State-licensed physicians and pharmacists seeking to operate under section 503A, may only use bulk drug substances in compounding drug products that:
- comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding; - are components of FDA-approved drug products if an applicable USP or NF monograph does not exist - or appear on FDA's list of bulk drug substances that can be used in compounding (the 503A) if such a monograph does not exist and the substance is not a component of an FDA-approved drug product.
What CANNOT be returned re: comprehensive care facility?
- compounded meds - refrigerated meds - CS II
CII labeling requirements
- date filled - serial number of RX - name of patient - name of prescriber - name and location of pharmacy - sig - cautionary statement if any - "crime to transfer the drug to anyone other than the patient"
Ongoing quality assurance program shall include the following information
- date of error - brief description of error - results of the evaluation by the QA program - remedial actions taken
CIII, CIV, and CV labeling requirements
- date of initial fill - serial number of RX - name of patient - name of prescriber - name and location of pharmacy - sig - cautionary statement if any - "crime to transfer the drug to anyone other than the patient"
What must the primary pharmacist document if outsourcing an Rx? (4)
- date of outsource - name of secondary pharmacy - names of primary/secondary pharmacists - date of return to primary pharmacy, if applicable
When transferring a prescription, secondary pharmacy must record the following
- date of transfer - date of original script - date of first fill - date of last refill - number of remaining refills - original script # - name/location of primary pharmacy - name of transferor - name of pharmacist transferee
Exceptions to obtaining a wholesale distribution permit (3)
- distributing less than 5% of annual sales for non-CDS and CDS - distributing "minimal quantities" to HCPs for office use (EXCLUDING compounded products) - returning stock medications to original distributor or manufacturer
DEA can inspect the following in a pharmacy
- examine & copy all records & reports - inspect premises within reasonable limits - take an inventory of CS
Examples of self-administered drugs
- eye drops - ear drops - topical therapies - IM injections - subQ injections - intranasal therapies - inhalation therapies I guess this includes vaccines
Ante room must contain
- eyewash station - a sink with hot and cold running water - waste containers for PPE - hazardous waste spill kit, if app
When must a pharmacist verify selection of medication for comprehensive care?
- final check of medication to be packaged
IP labeling requirements
- generic/brand name of med - strength - lot # of distributor/manufacturer - expiration/BUD
Vaccine restrictions under 18
- influenza: must be 9 years or older pursuant to protocol - 11-17: need rx and for cdc vaxes only in accordance w/ a vaccine-specific protocol
"Wholesale distributors" do NOT include
- intracompany sales (i.e. within a pharmacy chain) - distribution of samples by manufacturer's reps - drug returns to original manufacturer, distributor, or return processors - sale of minimum quantities by pharmacies to HCP for office use - sale or transfer of drugs for emergency medical reasons - pharmacy that distributes less than 5% of annual sales - third party logistics providers (people who move drugs around)
Definition of pharmaceutical specialities
- is in or makes use of a specialized setting - restricts or limits its services to a group or groups of individuals requiring specialty services
503A pharmacy exemptions
- label and directions for use - NDAs and ANDAs
Where contract not required for pharmacist to participate in DTM
- management of patients in an institutional facility - group model health maintenance organization (HMO)
What do you need an INDIVIDUALIZED controlled substance registration for?
- manufacture CS I through V - prescribing - distribute CS I through V - reverse distribute aka returns - dispense CII through V - conduct research with CI - V - importing CS - exporting CS - conducting a narcotic treatment program using CII - V ALL OF THESE NEED SEPARATE REGISTRATIONS!
"Wholesale distributors" include (4)
- manufacturers that distribute - brokers - repackagers - pharmacies if distribution accounts for more than 5% of annual sales
What may be returned to an AMS? Who may return medications back to AMS?
- meds in unit dose packaging after review by a pharmacist only pharmacists may return meds directly back to ams
a protocol may authorize the following:
- modification, continuation, and discontinuation (does not say initiation) - ordering of lab tests - monitoring therapy
Requirements for repositories accepting CDS returns
- modify DEA registration - MUST BE REGISTERED ALSO IN ORDER TO ACCEPT DONATIONS OR RETURNS FOR DISPOSAL (this registration require board approval) - install secured *one-way collection receptacle in front of pharmacy counter*, or provide serialized mail back envelopes to consumers - pharmacy personnel may not handle returned CDS - pharmacy may maintain receptacle at LTC facility - CDS and non-CDS may be commingled - destruction may be through use of reverse distributor, or rendering drugs "non-retrievable" - 2 witnesses to remove drugs from receptacle
Requirements to be a waiver pharmacy
- must have at least 1 pharmacist w/ education & training in speciality - restricted pharmacy services - need a waiver permit from the board of pharmacy
What must be documented in the patient record for self-admin drugs
- name of drug - dosage - site of administration - date/time of administration - instructions provided to patient
Delivery of prescription packaging requirements
- name of patient - storage requirements - tamper-evident container - shipping container does not indicate contents are medications - local or toll-free number - notification if medication appearance is different - notification if medication is temperature sensitive
What must the secondary pharmacist document if outsourcing an Rx? (5)
- name/address of primary pharmacy - names of primary/secondary pharmacists - date of outsource - date of return to primary pharmacy, if applicable - if more than 5% outsources, submit QA plan to board for approval
What type of meds can disposal programs accept?
- non CDS only - CDS - CDS commingled with non-CDS
What drugs are eligible for donation? Expiration date requirement for donated drugs?
- non-CDS - expiration date must not be more than 90 days from date of donation - only in manufacturer's or unit dose packaging
Prescription records upon pharmacy closing may be destroyed if:
- notice given to patients of date of destruction record may be - retrieved w/in 30 days of date of destruction
What must the pharmacy do to notify ppl that they are closing?
- notify all suppliers of closing date - notify public of closing date - notify patients where rx records have been transferred or how they can access records - return pharmacy and CDS permits
Pharmacy education outside of US
- pass FPGE exam through NABP - pass oral competency exam - NAPLEX & MPJE - 1560 hours of internship under pharmacist supervision
What info is needed for vax recordkeeping?
- patient info (name, address, DOB) - vaccine info (name, dose, lot #, exp date) - date, route, and site of admin - primary health provider name/address - pharmacist name - any adverse rxn - documentation of reporting to primary health provider - signed consent form - version of VIS
Who require permits?
- pharmacies (full-service) - waiver pharmacies - non-resident pharmacies - wholesale distributors - repository/drop-off pharmacy approval
Requirements for pharmacists to administer self-administered drugs
- pharmacist must have a prescription - pharmacist has active CPR and training in administration
Who does the BOP license?
- pharmacists - pharmacy techs - interns - vaccine administration certificates - drug therapy management approvals
ALL PA prescription must have the following on it:
- physician assistance's name and initials "PA-C" - supervising physician's name - business address - business telephone number cannot use pre-signed prescriptions faxed allowed within institution cannot transmit med order over the phone from outside the institution
what is a waiver pharmacy "waived" for?
- provide complete pharmaceutical services - provide services to general public and not restrict/limit services to any group of individuals
Sterile compounding pharmacy shall provide these as part of the inspection process
- quality assurance testing records - documentation of reporting AEs - microbial testing of a sampling of the sterile compounded prep - any other info requested to ensure compliance w/ USP 797
A pharmacist must do the following if administering a vax
- report to ImmuNet - contact prescriber or PCP at least once - provide VIS - observe pt for 15 mins - cannot charge more than $50, not including cost of vax
The permit holder shall ensure that the controlled environment for sterile compounding is
- structurally isolated from other areas within the pharmacy by means of restricted entry or access - air conditioned
Where may CIIs be stored in a pharmacy?
- through general inventory OR - secured in a locked cabinet
Where are permissible delivery of prescription allowed?
- to patient ANYWHERE - to authorized agent of patient - to patient's residence, regardless if they are home notify of delivery delay
What records need to be maintained for 5 years re: compounded sterile prep?
- training and competency eval of employees in sterile prep procedures - refrigerator and freezer temperatures - certification of sterile compounding environment, including ISO5 workstations, clean, and anterooms - quality control logs - documents re: expired or recalled preps - pharmacist and techs' checking/sign off process
What meds can be returned to a pharmacy servicing a comprehensive care facility?
- unadulterated as determined by pharmacist - CSIII-V if considered pharmacy inventory (aka not pt specific)
In an effort to reduce the risk of counterfeit drugs being introduced into the supply chain, the PDMA granted the FDA the authority to require whom to maintain a record that identifies each prior sale, purchase, or trade of the drugs they receive and distribute.
- wholesalers that are not manufacturers - wholesalers that are not authorized by a manufacturer of the drug (secondary wholesaler) really only applies to secondary wholesalers
Content of protocol
- written - condition of disease-state specific - list of meds - monitoring parameters including lab tests - circumstances requiring physician contact - statement prohibiting substitution of a chemically dissimilar drug unless permitted - circumstances where rph may alter doses, treatment regimen, or swtich agents - must be documented - provisions that may be customized - action plan for situations not addressed in protocol
A therapy management contract shall terminate ____________ from date of its signing, unless renewed by the licensed physician, licensed pharmacist, and patient
1 year
For second fills and other refills, non-CDS prescription expires after how long?
1 year
If a prescription is labeled as a PRN medication, how long does the script live?
1 year
What are the requirements for the pharmacist to enter in a physician-pharmacist agreement?
1) licensed 2) PharmD or equiv 3) approved by the board - cannot have disciplinary action within 5 years before submitting an app - 1000 hours of relevant clinical experience, 320 hours in structure exp program - document training related to disease state specified in protocol
Unless an alternative time period is stated in the physician-pharmacist agreement, the pharmacist shall inform the physician within 48 hours if the pharmacist:
1) modifies the dose or agent under the therapy management contract 2) detects an abnormal result from assessment activity
Options for filing CDS
1. CDS* vs. non-CDS 2. CII vs. everything else* 3. CII, CIII-V, everything else *CIII, IV and V must be made readily identifiable and retrievable by use of a red C stamp not less than 1 inch high UNLESS electronic system
A human drug product compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility can qualify for exemptions such as:
1. Drug approval requirements in section 505 of the FD&C Act 2. The requirement to be labeled with adequate directions for use 3. Track and trace requirements in section 582 of the FD&C Act.
Exceptions to using methadone only for pain (3)
1. Patients comes to ER for withdrawal - cannot exceed 3 DS 2. patient is in the hospital for another reason - can continue therapy 3. patient has intractable pain and no relief or cure is possible after reasonable efforts
If a prescriber uses an agent, what can she/he do?
1. Prepare prescription for prescriber's signature 2. Fax signed prescription to pharmacy 3. Relay oral prescription of prescriber to pharmacy (C3 - C5) - NOT CIIS CIIs must be written
Outsourcing facilities may not compound a drug product that includes a bulk drug substance unless:
1. The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list - which there is none there), or 2. the drug product compounded from such bulk drug substance appears on FDA's drug shortage list at the time of compounding, distribution and dispensing.
Who may a full-service pharmacy conduct whole sale distribution with?
1. another pharmacy 2. a wholesale distributor WITH approval from board 3. must keep separate records
Who may a full-service pharmacy distribute to?
1. another pharmacy 2. distributor must notify the Board and maintain records of distribution to distributors separately
The prescription drug marketing act 4 main areas of address
1. bans reimportation of american-made prescription human drugs rom foreign countries 2. regulates the distribution of prescription "drug samples" 3. prohibits, w/ certain exceptions, the resale of Rx drugs purchased by hospitals, health care entities, and charitable institutions 4. regulates prescription drug wholesale distributors
CIIs cannot be faxed. 3 exceptions
1. compounded preparations for direct administration ot patient 2. LTCF patient 3. Hospice patient Must document on RX why CII is being filled through fax
3 types of permits
1. full pharmacy permit 2. waiver permit 3. non-resident permit
When must a pharmacy perform an inventory count for all CDS
1. initial before beginning business 2. every 2 years at a minimum
When can a pharmacist substitute a generically equivalent drug
1. not written as DAW 2. substitution is recognized in the Orange Book 3. the consumer is charged less for the substitute drug or device than the brand
What must the pharmacist do if a drug or device is substituted for generic?
1. notify the patient in writing that the drug/device dispensed is a generic 2. record on the prescription and keep a record of the name and manufacturer of the substituted drug/device
What does product tracing information include for DSCSA?
1.Transaction information (name of drug, strength, dosage, NDC, container size, # of containers, lot #, transaction date, shipment date, name/address of entity from which and to which ownership is transferred) 2.Transaction history 3.Transaction statement
A hospital pharmacy may receive samples at the request of a licensed practitioner, provided there is a receipt containing:
1.name and address of the requesting prescriber 2.name and address of the hospital or health care entity designated to receive the drug sample 3.name and address, title, and signature of the person acknowledging delivery of the drug sample 4.proprietary or established name and strength of the drug sample 5.quantity and lot control number 6.date of delivery
How many CEs are required to dispense? Renewal period?
10 CEs in dispense per permit period permit period: 5 years
Tech first renewal period, required CEs
10 only
How many hours do interns need from IPPE/APPE to sit for license?
1000 hours
For sterile compound labeling, if no time is stated for the BUD, what is the time presumed to be?
11:59 pm of the stated beyond use date
How many members on the BOP?
12 members (10 pharmacists, 2 consumers) -2 from chain store -2 from independent pharmacies -2 from acute care hospital -1 from long-term care facility -1 from home infusion/home care services - 2 at-large - 2 consumer reps
First fill must be dispensed within how many days of prescription written?
120 days
How many DS may a pharmacist dispense in an an unauthorized refill (non-emergency)?
14 day supply
How long before closing should a pharmacy notify the board?
14 days prior to "ceasing operations"
water-containing oral formulation BUD
14 days refrigerated
Age limit for techs and other requirements to be a tech
17 years old - must be high school grad or enrolled in good standing in a high school - need background check - pass an exam - tech training program
How many witnesses must there be to remove drugs from receptacle?
2
Outsourcing facilities must be complaint with 503B, which includes submitting a report ____ times/year regarding the drugs compounded by the facility and submitting reports about adverse events
2 times (every june and december) Outsourcing facilities are also subject to FDA inspections according to a risk-based schedule, specific adverse event reporting requirements, and other conditions that help to mitigate the risks of the drug products they compound.
222 Forms, CDS inventory are to be maintained for how long?
2 years
CDS records are maintained for how long?
2 years
Pharmacy must contain a logbook of pseudoephedrine sales for how long
2 years
Intern license valid for how many years?
2 years - can only renew 1 time expires on 2 year anniversary of the month of intern's birth month
# of CEs required for a tech
20 every 2 years; keep records x 4 years
minimum age to be a designated rep for wholesale permit
21
A pharmacy compounding sterile infusion preparations shall provide a ____-hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its pharmacists.
24 hour phone number
Healthcare facilities with remote AMS must have access to a pharmacist for how long?
24 hours
Starter doses from a decentralized AMS must be approved within how much time?
24 hours
PDMP data must be reported every
24 hours; electronically submitted - even if you do not dispense anything
Pharmacist to intern ratio
2:1 at any one time
How many copies of form 222 do you need when ordering?
3 copies 1. pharmacy sends copy 1 and 2 to wholesaler - wholesaler keeps a copy and sends another to DEA 2. pharmacy keeps copy 3 and records amount received for each item and date received
Controlled substance registration is valid for how many years?
3 years
Must maintain wholesale distribution records for how many years?
3 years
Pedigrees should be maintained for how long from date of sale/transfer?
3 years Available for inspection within 5 business days
For persons under 18, vax records should be kept for
3 years + age of majority or 5 years whichever is longer
Daily limit of pseudoephedrine sales
3.6 grams/purchaser, regardless of # of transactions
Pharmacy signage must be removed within how many days of closure?
30 days
water-containing semisolid formulation BUD
30 days
Regarding the MD Medicaid program, original non-controlled scripts must be filled with _____ days and must maintain record for ____ years
30 days 6 years
CIII, IV, and CV days supply for institutional patients cannot exceed
34 day supply OR 100 units is dispensed at one time
Board of pharmacy term
4 years
Medication orders must be countersigned by a supervising physician within _______ in a hospital, correctional facility, or detention center for PA prescribing ______ in a public health facility
48 hours 72 hours
A pharmacy shall maintain records of media fill verification results for how many years?
5 years
Adult vax records should be kept for
5 years
How long must electronic prescriptions be maintained?
5 years
How long must hard copy prescriptions be maintained?
5 years
Prescription records are maintained for how long
5 years
Prescription record for hydrocodone must be maintained for how long?
5 years Fed law says 2 years, but 5 is more strict
Sterile compounding patient prescription records shall be kept for how many years?
5 years either at inspection site or immediately retrievable by computer or other electronic means
How long are records maintained for transferred rx at the primary AND secondary pharmacy?
5 years for both
Self-admin drugs records must be maintained for how long?
5 years, unless otherwise required by the law
Can hospitals continue to purchase non patient-specific compounded products from 503A compounding pharmacies for use in outpatient clinics?
503A pharmacies are prohibited from compounding and distributing non patient-specific medications for use in physician offices or clinics. can: 1) purchase non patient-specific compounded medications from 503B outsourcing facilities; or 2) compound products on the hospital campus and distribute them only within the 1-mile radius to facilities under the hospital or health system's common control.
Non-resident pharmacist must provide a toll-free phone number at least:
6 days per week or 40 hours per week
Non-aqueous BUD
6 months
Tech training program cannot exceed more than _____ and includes _____ hours of work experience
6 months and includes 160 hours of work experience
HIPAA patient acknowledgements of privacy notice must be kept on file for how long?
6 years
Pharmacies must maintain transaction information under DSCSA for how many years?
6 years
Pharmacy transaction records under DSCSA must be maintained for how long?
6 years
# of days the BOP will approve the operation of a pharmacy from a temporary site
60 days
A pharmacy must be operational within how many days of permit issuance?
60 days operational - actively compounding, dispensing, or distributing
How long do you have to notify a prescriber of an unauthorized refill (emergency)?
7 days
If a pharmacists dispenses a CII in a case of an emergency (i.e. doctor calls in a prescription), prescriber must have the RX delivered to the pharmacist within
7 days if mailed, postmarked within 7 days If not received, must report practitioner to Department of Health
Within how many hours must you notify prescriber of the refusal to dispense an RX based on professional judgment
72 hours
Within how many hours must you provide record of inventory if it is requested by OCSA?
72 hours
For partial fills on CII, remainder must be filled within...
72 hours or the remainder must be cancelled if pt decides to partially refilled RX, that RX must stay with the pharmacy - cannot fill anywhere else
30-day limit of pseudoephedrine sales
9 grams/purchaser
Who must supervise an outsourcing facility?
A pharmacist
The permit holder shall appoint whom as director of pharmacy for a comprehensive care facility?
A pharmacist must be the director of pharmacy - licensed in MD - onsite full time - in charge of only one CCF
Where must all donated drugs be forwarded to?
A repository for ultimate redispensing
Where must prescription drugs/devices be purchased from?
A wholesale distributor *licensed in MD* or another pharmacy
Written prescriptions are allowed for what type of drugs?
ALL non-CDS CDS II-V
Must apply for this for generic drug approval
Abbreviated New Drug Application (ANDA)
When can you apply for controlled substance permit?
After the Board of Pharmacy does an opening inspection
How many times can a non-CDS be transferred?
As many times as it's allowed to be refilled
If closing a pharmacy, who must you notify?
BOP and OCSA
Outsourcing pharmacy requirements
Both pharmacies are to be licensed in MD or apart of a federal government
If outsourcing a prescription, who must perform the final check?
Both pharmacists from the primary and secondary pharmacy (if returned to primary pharmacy for dispensing) - this is standard of practice
What drugs must be reported to PDMP?
CDS II - V that are dispensed
Methadone schedule
CII
Counts of CDS inventory
CII - exact count CIII - V estimate unless > 1000 tablets If 1000 tablets exactly, can estimate
If a CII and CIII are the same script, which one needs to be moved to a new script?
CIII CII must stay on original script
Partial filling of CII for long-term care or for terminally ill time limit
CIIs may be partially filled Complete dispensing must be within 60 days or less
For an institutional pharmacy, what are the rules for CDS inventory?
CIIs must have on-demand perpetual inventory At least monthly hand-count of all CDS can be done by pharmacist or tech
What if permit holder is not available and wants to order CIIs?
Can grant power of attorney to another person to sign DEA order forms Only individuals specifically authorized by DEA may sign forms
All prescription drug *containers* must be labeled with what statement?
Caution: Federal Law Prohibits dispensing without a prescription
Who can compound?
Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist
Form for manufacturers/distributors to register with the DEA to handle CDS
DEA Form 225
Form used to report *Significant* Loss of Controlled Substances
DEA form 106
Form used for ordering CIIs
DEA form 222
Form to apply for controlled substance registration
DEA form 224
Destroying drugs onsite requires what form
DEA form 41
What is the Ryan Haight Online Consumer Protection Act of 2008?
Designed to combat the proliferation of "rogue Internet sites". Says it's illegal under federal law to deliver, distribute or dispense a control by means of the Internet unless you are authorized by the DEA. Regulates online pharmacies selling/ dispensing CDS Applies to internet pharmacies dispensing CDS ONLY not non-CDS
For delegation of pharmacy act, what must the pharmacist do?
Directly supervise vs. just supervision
Established the category of prescription drugs and labeling requirements for certain drugs to be dispensed w/ a prescription only
Durhman-Humphrey Amendment of 1951
What is required from DSCSA?
Effective 1/1/15: 1. May only distribute to "authorized trading partner" 2. Must document, maintain and pass on product tracing information with each transaction 3. Must have process to respond to federal and state requests for information 4. Must have system to investigate and quarantine suspect products
Prescription inventory must be conducted how often?
Every 2 years from date inventory was received
T/F final check does not have to be performed for an AMS in a centralized pharmacy
F
T/F The board of pharmacy must perform the closing inspections
F - OCSA can act as the board's agent for closing inspections
T/F technicians cannot give or accept transferred prescriptions
F - can give non-CDS transfers cannot receive any transferred rxs
T/F pharmacy permits are transferrable
F - if going to a new location, must get a new permit; if someone other than the permit holder is taking over, need new permit
T/F CII Rx can never be oral
F - in emergencies, they can be
T/F donated products can be inventoried with pharmacy products
F - must be inventoried separately
T/F only pharmacies can be drop-off sites
F - other health care facility approved by Board can also be a drop off-site
T/F Techs and interns cannot compound prescriptions
F - they can, but only under pharmacist supervision cannot "independently compound rxs"
T/F you do not need consent to inspect financial records for CDS
F - yes you do
T/F you do need consent for a regular inspection for CDS
F - you do not, routine inspections are consented through the permit application process
T/F an MD pharmacist can be employed by more than 1 non-resident pharmacy
FALSE only one
T/F any pharmacy can dispense methadone for opioid addition
FALSE - pharmacy must be registered as part of a methadone treatment program in order to dispense it for addiction
Outsourcing facility must register with
FDA
Required that the label of a drug contain adequate directions for use by the consumer
FDCA of 1938
T/F A prescriber can own a pharmacy in MD
False
T/F a physician can write a CII RX to obtain drugs for office use
False "I want oxy for office use"
T/F CDS are allowed in portable drug kits for home health agencies and hospice programs
False they are allowed in interim boxes and emergency drug kits tho
T/F DEA does NOT require consent prior to conducting an inspection
False - DEA must obtained SIGNED consent vs. BOP doesn't require consent Federal vs. state; i think for state you do not need consent alternative: DEA needs to obtain an administrative inspection warrant
T/F In MD, a pharmacist is required to substitute a generic under the law
False - MD is a permissive not a mandatory state for generic substitution
T/F pharmacists can dispense samples
False - OK to be dispensed by PRESCRIBER, but never by pharmacist
T/F Nurse midwives cannot prescribe CDS
False - The prescribing of controlled substances on Schedules II, III, IV, and V commonly used in the practice of nurse midwifery
T/F the prescriber is responsible for that the dispensed controlled substance is for a legitimate medical purpose
False - a pharmacist is
T/F Schedule II RXs cannot be electronic
False - but must be compliant w/ federal law
T/F Waiver pharmacies are limited to just 1 specialty
False - but need to have pharmacists trained in all included specialties
T/F drugs samples are allowed to be held in a community pharmacy
False - no samples are allowed in community pharmacies period.
T/F a separate prescription is required for CS II ONLY
False - one is needed for each CDS
T/F NPs may prescribe drugs only as a dependent
False - they are independents
For a faxed CII, you do not need an actual prescription?
False, must have RX before DISPENSING the medication to the patient Unless it lies within the 3 exceptions
T/F full-service pharmacies may not perform any pharmaceutical specialty services
False, they can but still need pharmacists in staff that are competent in that speciality do not need separate permit
T/F CIII - V can be written on preprinted rx pad
False; only non-CDS
When can you use pre-printed prescription pads?
For non-CDS only
Form needed to distribute CIIs from one pharmacy to another
Form 222 Can also for pharmacy sales of CIIs to other registrants (i.e. prescribers for office use)
What type of prescriptions MUST have a manual signature (no e-sig or rubber stamp)
Hard copy Faxed prescription
Who may serve as custodian of samples for in-hospital physicians?
Hospital pharmacy - they do not own the sample, just holding the sample
Marijuana schedule
I - federal government recognition
Cocaine schedule
II
Phenobarbital schedule
IV
Meprobamate schedule
IV - anxiolytic
When can a drug be reimported from a foreign country back to the USA?
If the manufacturer reimports it wholesale distributors cannot bring them back
Pharmacists must report vaccine administration information to.... and adverse events to....
Immunet VAERS
What is a DATA waiver 2020?
In 2000 Congress passed DATA-2000, a law that allows physicians, to become eligible to prescribe specially approved opioid-based medications specifically for the treatment of opioid addiction. Buprenorphine/naloxone (Suboxone®) and buprenorphine (Subutex®) became the first medications to be approved and affected by this law. they become eligible to apply for a special waiver which allows them to treat addiction with above mentioned medications. This same law caps the number of addicted patients a physician can treat at any one time to 30 through the first year following certification, expandable to 100 patients thereafter. No other medications have such restrictions, including the prescription drugs people get addicted to and die from.
When can a CDS II be oral?
In a state of emergency
Where do wholesale distributors need to be licensed?
In the state they are located in the state they ship drugs to
Established that drugs must have proved both safe and effective prior to marketing in the interstate commerce
Kefauver-Harris Amendments of 1952
Who can compound under 503a?
Licensed pharmacist or physician
If a CDS RX is printed out or faxed, how must it be signed?
MANUALLY
Who are authorized prescribers (10)?
MD DO Dentist Podiatrist Veterinarian PAs ARNPs Nurse midwives NPs (OB/GYN, pediatric, psych) Optometrist
Authorized dispensers other than pharmacist (9)
MD DO Dentists Podiatrists Veterinarians ARNPs Midwives NPs Optometrists
When do permits expire?
May 31st every other year
Who may wholesale drug distributors distribute to?
May only distribute drugs to persons authorized by law to dispense or receive prescription drugs May not receive payment from any person other than person on license/permit May only deliver to premises listed on license/permit or hospital pharmacy receiving area
When may you repackage a drug dispensed by another pharmacy?
May repackage when receive drugs *directly from*: • manufacturer's original container; • another pharmacy licensed in MD. or operated by federal gov't. - must be repackaged and dispensed all at 1 time
MD additional CDS registration
Md. CDS registration required in addition to DEA registration to "possess, manufacture, distribute, or dispense (and prescribe) CDS"
When MUST you use tamper-proof pads?
Medicaid patients
Under the Ryan Haight act, how often must you report to DEA the count of CDS dispensed?
Monthly
Non-resident pharmacy requirements that are dispensing INTO the state for MD patients
Must have at least one Md. licensed pharmacist on staff who is designated as responsible for providing pharmaceutical services to patients in the State Non-resident pharmacies must hold a permit issued by the MD board Also need a valid permit in the state in which it is located
Other dispenser can dispense under what requirements?
Must obtain a dispensing permit from respective board Must "personally prepare and dispense" May only dispense to own patients when pharmacy is not conveniently available
If multiple CDS prescribed on same prescription blank - what must you do?
Must write out and file a separate prescription for each CDS (not for more than one C2)
What can be changed w/o new permit application?
Name change ONLY and may be obtained w/in 30 days
FDA approval of this allows the manufacturer to market the drug in interstate commerce
New Drug Application
Are rubber stamps for prescriber's signature permissible on hard copy Rxs?
No
Can clean rooms contain sinks or floor drains?
No
Can outsourcing facilities compound drugs that were withdrawn or removed from the market for safety reasons? How about on FDA's current list of drugs with demonstrable difficulties?
No
Is an outsourcing facility required to be a licensed pharmacy?
No
Are CEs required for first renewal period after graduation?
No - if license is obtained within 1 year of graduation
Can a technician accept a transfer for a CDS? non-CDS?
No - only pharmacists can accept/receive transfers
Are biosimilars included under the Hatch-Waxman act?
No - they are close but not exact copies of biologics bottom line: biosimilars are NOT equivalent to biologics
Is an rx valid if a physician generates an electronic Rx and then print it out w/ a e-signature?
No, manual signature must be on all hard copies
Can an outsourcing facility compound nonsterile products only?
No, need to compound sterile products
How many times can a CII be transferred?
None
What is the limit of pharmacist/tech ratio?
None
A pharmacy must make available ___________ to each patient re: HIPAA
Notice of Privacy Practices
Prior to closing, who must you notify 14 days in advance?
OCSA and board
Who is allowed to inspect pharmacies during normal business hours as part of agreement for permit?
OCSA, DEA, board
How many times can a CIII-V be transferred?
ONCE unless it's within a chain store w/ unified prescription records
Dispensers are subject to inspection by
OSCA
What can a pharmacy dispense methadone for?
Pain - can be dispensed by any prescriber/pharmacy
Reciprocity requirements?
Pass MPJE and meet criteria of regular license Show evidence of 520 hours of pharmacy experience after graduation
If a prescription is outsourced, what information must be relayed to the patient?
Patient is informed in writing of outsource and name/address of secondary pharmacy Let the patient know that the primary pharmacy didn't actually prepare the drug
How must licenses be displayed in a pharmacy? (3)
Pharmacist license - posted pharmacy intern/tech - posted or on person pharmacy permit - posted
Pharmacist/technician responsibility when stocking an AMS
Pharmacist must verify selection of medication/technician may stock system w/ bar code technology
Who must summarize oral communications b/w physician and pharmacist?
Pharmacist, then forward to physician
What is a non-resident pharmacy?
Pharmacy located outside the State that ships, mails, or delivers drugs/devices to a person in this State per a prescription think mail order
Who can only dispense samples and starter doses?
Physician assistant
Who is a dependent prescriber?
Physician assistant
What is a prescription area?
Portion of an establishment for which a pharmacy permit has been issued which contains patient records, prescription devices and prescription drugs this area must be secured w/ proper temp and ventilation for drug storage
What act bans the sale, purchase of, or trade (including the offer to sell, purchase or trade) in drug samples
Prescription Drug Marketing Act
What is a donation program?
Receive donated drugs for purposes of re-dispensing to needy individuals cannot accept returned drugs for disposal
What does the Drug Supply Chain Security Act (DSCSA) mandate?
Requires dispensers to capture and maintain product tracing information (transaction information, transaction history, transaction statement)
No currently accepted medical use in the U.S.
Schedule I cannot be dispensed OR prescribed
Controlled group that may lead to severe physical or psychological dependence
Schedule II
Oral prescriptions are allowed for what type of drugs?
Schedule III-V non-CDS NOT FOR CIIs - must be handwritten except in a state of emergency
Why are wholesale distributors a thing?
To prevent individuals who can obtain drugs at lower prices from reselling those drugs unless they are licensed as a wholesaler
Outsourcing vs. transfer
Transfer: means a primary pharmacy permanently gives the authority to fill a prescription to a secondary pharmacy at the request of a patient Outsource: means a primary pharmacy utilizes a secondary pharmacy to prepare a prescription, but the primary pharmacy retains ownership of the prescription
Buprenorphine can be filled at pharmacies
True
T/F A pharmacist may prepare batched sterile preparations for future use in limited quantities supported by prior valid prescriptions or physician orders before receiving a valid written prescription or medication order.
True
T/F All CVs in MD require an Rx
True
T/F CDS prescribers must query the PDMP before prescribing an opioid or BZD
True
T/F CIII - CVs can be partially refilled
True
T/F Compounders that have not registered as outsourcing facilities, who seek to operate under section 503A of the FD&C Act, can only distribute compounded drugs based on the receipt of valid prescriptions for identified individual patients.
True
T/F De-identified data from PDMP may be provided for research, analysis, and education
True
T/F Faxed prescription for *CII* for a hospice patient can serve as the original prescription
True
T/F Faxed prescriptions for CII to pharmacies can be treated as originals in hospice or LTCF
True
T/F Need to contact doctor if cannot fill full CII RX
True
T/F On receipt of specific instructions from the physician regarding a specific patient, the pharmacist may execute the physician's specific instructions even if the instructions deviate from the protocol.
True
T/F Pharmacist can administer insulin to patients
True
T/F Pharmacists must be immediately available on the premises to provide pharmacy services at all times the pharmacy is in operation
True
T/F Physician may prescribe and pharmacists may dispense drugs for unapproved use
True
T/F a pharmacist may not associated as a partner, coowner, or employee of a pharmacy "owned wholly or substantially" by an authorized prescriber or group of authorized prescribers
True
T/F home infusion pharmacies may accept faxed CII
True
T/F patient/prescriber may request own data from PDMP
True
T/F pharmacy may maintain repository receptacle at LTC facility
True
T/F OSCA may inspect premises of registrant without warrant
True OSCA only has powers over the CDS license - they can't close a pharmacy down
T/F decentralized pharmacies may operate under same permit as central pharmacy
True - but central pharmacy must disclose all decentralized pharmacy locations on applications
T/F Each pharmacy has its own 222 form
True - cannot "borrow" another pharmacy's 222
T/F Faxed prescription for *CII* for a long-term care facility patient can serve as the original prescription
True - do not need additional written RX
T/F pharmacies can be BOTH a repository and a drop off site
True - especially if they wish to redispense
T/F PDMP data is not subject to subpoena for civil litigation (i.e. for suing purposes)
True - law enforcement, licensing boards may obtain PDMP data reports upon issue of subpoena, but not to sue anyone
T/F Outsourcing facilities can distribute compounded drugs for "office use" without receiving prescriptions for identified individual patients.
True - this is a big advantage of registering as a 503b outsourcing facility In other words, only outsourcing facilities may distribute compounded drugs to healthcare facilities and practitioners without first receiving a patient-specific prescription.
T/F Mid-level practitioners (i.e. NPs, midwives) authorized to prescribe controlled dangerous substance must have their own DEA number.
True They cannot use the DEA number of a supervising physician to issue prescriptions for controlled dangerous substances.
T/F disciplinary orders are public documents
True and reported to: - national practitioners data bank - board's website - board's newsletter - NABP - Maryland public information act
T/F MD law does allow for "office-use" prescriptions
True. Federal law does not but its more directed at compounding non-compounded drug, you can do office use - no controls though?
What regulations must 503A pharmacies comply with?
USP 797 and 795
Single dispensing of dosage units limits
Up to the total number authorized by the original prescription and any refills but collectively cannot exceed 90-day supply remaining 2 RXs must have notion indicating the date on which they can be filled Does not apply to CDS
When PHI is used for marketing/fundraising purposes, what must be obtained
WRITTEN consent
Where can a pharmacy return drugs to? For CDS?
Wholesale distributor or reverse distributor DEA-registered reverse distributor returning drugs is not considered drug distribution - no distributor permit required
What are wholesale distributors?
Wholesale drug distributors are a link between manufacturers and pharmacists. Their role is to ensure prescription medications are delivered safely and efficiently every day to thousands of health care practitioners and pharmacies nationwide.
How can an individual prescribe under the hospital's registration number?
With an internal control number added to the hospital's DEA number
Can a tech give drug prices?
Yes
Can you take a drug out of the orange book in MD and deem it not substitutable?
Yes
Can a technician give a transfer to a pharmacist?
Yes, but only for non-CDS
Can CDS be electronic prescriptions?
Yes, electronic prescriptions shall be created and signed using an application and one that is DEA-audited Rx must be digitally signed through an approved system Pharmacy must archive the e-prescription
Can a pharmacist who does not possess a doctor of pharmacy be in a physician-pharmacist agreement?
Yes, must document training which includes a series of stuff
Does a pharmacy who is located in VA but dispensing CDS into MD need to report to PDMP?
Yes, non-resident pharmacies must Dispensing prescribers also do too
Can an outsourcing facility compound drugs based on non-patient specific purchase orders?
Yes, they can also obtain rx for individual patients (but they don't usually do this)
CIIs days supply for institutional patients cannot exceed
a 7 day supply - CDS cannot be in possession of the ultimate user
A pharmacy may NOT deliver prescription medications to where?
a depot - location where filled prescriptions are stored before delivery to patient aka a holding area
Definition of "self-administered" drug?
a drug that is regularly administered by the patient for whom the drug is *prescribed* or by an individual who is not otherwise authorized to administer drugs
What is an unauthorized refill?
a medication that has run out of refills
When a pharmacy is registered as a methadone treatment program, the prescriber must have:
a special DEA number; an X will replace the first character methadone used for addiction must be written by prescriber registered by DEA as a NTF
What is a therapy management contract?
a voluntary, written arrangement that is disease-state specific signed by each party to the arrangement between one licensed pharmacists and physician, patient
Infusion pharmacy service (waiver permit) location
alternate care site environment - location other than inpatient hospital permit holder needs to ensure compliance w/ 797, assigned supervising pharmacist, etc
How frequently must the board inspect a pharmacy?
annually
The Combat Meth Epi Act requires vendors to self-certify ______ that staff have been trained
annually
Vaccine specific protocols must be *signed* and *dated* how often by pharmacist?
annually *note*: no signature needed by any prescribers or providers
Within a Hospital, Correctional Facility, or Detention Center, a PA may write a medication order for Schedule II, III, IV and V medications, noncontrolled substances, and non prescription medications only when they
are to be administered on site
A pharmacy permit hold shall analyze records re: ongoing quality assurance program how often?
at least every 3 months
For unauthorized refills, what are the requirements to fill?(4)
attempted to contact prescriber prescription is NOT a CDS drug/device is essential to maintenance of life and continuation of therapy of a chronic condition interruption of therapy may be detrimental to patient's health
for pharmacies accepting non-CDS only, where must the separate secure container be located?
behind the prescription counter
What can a pharmacy dispense for addiction treatment without having to be registered in any program?
buprenorphine i.e. suboxone
An outsourcing facility must comply with what standards?
cGMP standards - these are FDA standards NOT USP 795 or 797
What is a full service pharmacy
complete pharmaceutical services by preparing and dispensing all prescriptions that reasonably may be expected of a pharmacy
Unlicensed personnel must be trained regarding:
confidentiality of records/medical info & sanitation, hygiene in prescription area
What must a pharmacist document on an authorized refill?
date & quantity of drug/device sign it
For rx record keeping, patient profile/prescription must include 3 specific things
date of filling/refilling pharmacist initials that filled or refilled data-entry tech's initials
BOP allowable sanctions
denial reprimand probation suspension revocation fines
Who is in charge of a comprehensive care facility?
director of pharmacy - must be on-site and full time and can only be responsible for 1 comp care pharmacy
Single dispensing of dosage units for contraceptives
does not exceed a 12-month supply
What established the national tracing system and set national licensing standards for wholesale distribution
drug supply chain security act "DSCSA"
When can the BOP inspect a pharmacy?
during business hours - can be unannounced
Non-CDS electronic prescriptions MUST be transmitted via what? What is the exception?
electronic intermediaries certified by MD health care commission Exemption: closed systems
Drugs covered under the Combat Methamphetamine Epidemic Act of 2005
ephedrine pseudoephedrine phenylpropanolamine please do not pick phenylephrine - this is a vasopressor covers pharmacies, grocery stores, kiosks
Each pharmacy permit holder shall conduct an analysis of its medication delivery system at least ____________ to determine which meds in the rx area of the pharmacy are high-alert meds
every 6 months
T/F Nurse midwives cannot prescribe CDS
false
T/F a pharmacy tech may accept or transcribe a new rx
false
T/F pharmacy permits are transferrable
false
T/F prescriber needs a permit to dispense starter doses
false
T/F starter doses do not need to be reported to PDMP
false
T/F comprehensive care facilities include acute care and assisted living facilities
false they are a facility which admits patients suffering from disease, disabilities, or advanced age, requiring medical service by or under supervision of a registered nurse (aka, nursing home)
T/F partial filling of CIIs are NOT allowed
false - allowed only if unable to dispense full amount
T/F PDMP reporting is based on sound judgment
false - it is mandatory
T/F pharmacist may dispense from a temporary site without board approval
false - need approval
T/F wholesale distributors are not subject to routine inspection
false - requires permit, inspection unless distributors do not have products
T/F starter doses do not need to comply with labeling requirements as they are samples
false - they are NOT samples of 72 hrs or shorter durations OR prior to obtaining a larger quantity of the drug/device to complete therapy
What is an unauthorized refill in a state of emergency?
federal or state declaration of emergency; can't contact prescriber again, this does not apply to CDS
Decentralized pharmacies must be supervised by pharmacist on-site EXCEPT
for rounds
What is needed to dispense needles and syringes?
good faith patient ID indication of need no rx required
Who does NOT have to report to PDMP?
hospitals veterinarians dispensing in hospice programs, LTC, DDA patients, opioid maintenance programs i.e. suboxone dispensed at community pharmacy needs to be recorded but not from an opioid maintenance program
Where must the receptacle be if a repository accepting CDS?
in front of pharmacy counter - should be a secured one-way collection receptacle
Form used for ordering CIII-V
invoices - ordered with rest of merchandise
When will a tech license expire? Renewal period
last day of birth month following 1 year of initial registration renew q2 years
CS III opium concentration
less than or equal to 100mg/100mL or 100mg/100g or less than or equal to 5mg per dosage unit
Schedule V codeine preparation concentrations
less than or equal to 200mg/100mL or less than or equal to 200mg/100g
Schedule III codeine combination product dose
less than or equal to 90 mg per dosage unit or 1.8g/100mL
Drugs on the shelves MUST have what type of expiration date?
manufacturer's expiration date all expired drugs must be removed from inventory
If selling CDS online, what must a pharmacy obtain?
modified DEA registration notify: - DEA and all relevant state boards of pharmacy the DEA#s of all participating practitioners/pharmacies and all site addresses disclose on webpage - all pharmacies - all pharmacists - statement "this online pharmacy will only dispense a CS to a person who has a valid rx..."
For second fills and other refills, CDS II prescription expires after how long?
n/a - no refills allowed
If outsourcing a prescription, what must the prescription label contain?
name, address, phone of PRIMARY pharmacy
T/F pharmacy intern can be P1s
no, by definition, must have completed 1 year of pharmacy school FYI: need background check, cannot accept return of RX drugs or devices directly from patient
Can CCFs receive faxed rxs?
no? chart order, verbal order, written, electronic
How many times can a CII be refilled?
none
PDMP violation for misuse of information
not exceeding 1 year of imprisonment or fine up to $10,000 or both
T/F pt needs a prescription for pseudoephrine products bc they are behind the counter and scheduled
not scheduled do not need an rx products must be behind the counter or locked cabinet
How many DS may a pharmacist dispense in an unauthorized refill in an emergency??
not to exceed 30 day supply
Prescription records upon pharmacy closing may be transferred with:
notice to the patient documentation to the Board
Who may a waiver pharmacy distribute to?
only to another pharmacy must maintain separate distribution records
When can an emergency drug kit be dispensed?
only with a written order
Who may a waiver pharmacy conduct whole sale distribution with?
only with another pharmacy
What can outsourcing facilities compound and distribute?
outsourcing facilities can compound and distribute sterile and non-sterile nonpatient-specific drug products to hospitals, clinics, and health care practitioners for office use.
How can hospitals, clinics, and health care practitioners can obtain non-patient-specific compounded drug products from:
outsourcing facilities registered under section 503B
Who can an outsourcing facility dispense directly to?
patient OR return to primary pharmacy for dispensing
What type of signatures must be on hard copy prescriptions?
pen-to-paper signatures - NO EXCEPTIONS
What are 503A pharmacies?
pharmacies engaged in sterile and nonsterile compounding must have an identifiable patient for each prescription
If dispensing outside a pharmacy that is NOT from a location that is permissible, what must be obtained?
pharmacist must apply for a waiver pharmacy permit and obtain board approval board approval must be renewed at time of license renewal
CDS transfer must occur between
pharmacist to pharmacist transfers may only be to another DEA registered pharmacy
Who has sole possession of means of access to pharmacy. What is the exception?
pharmacists in emergencies (i.e. fire, water leak, electrical failure)
Who must accept donated drugs?
pharmacists ONLY cannot delegate to tech pharmacist must review and accept the donated item
Who needs to report changes in mailing address and place of employment within 30 days to the board?
pharmacists, techs, and interns
For electronic prescriptions for CDS, what additional requirements must be met?
pharmacy must use: - system that undergoes 3rd party audit by DEA approved auditor - system provides audit to pharmacy - any annotations or changes to rx must be stored or linked electronically
In the pseudoephedrine log book, what must be documented by pharmacy vs. purchaser?
pharmacy: product name, quantity sold purchaser: date and time of sale, name, address, signature Need valid photo ID
Who must sign the therapy management contract?
physician pharmacist patient
Physician-pharmacist agreement must be submitted to:
physician - BOphysicians pharmacist - BOPharmacy
Where may CIII-V be stored in a pharmacy?
placed with general inventory
Who can access PDMP data?
prescribers dispensers delegates by *subpoena* by law enforcement, attorney general's office, prescriber/dispenser licensing boards
When must a pharmacist query the PDMP if they have suspicion?
prior to dispensing
What is the BOP's mission
public protection through establishing minimum licensing qualifications, monitoring, and enforcement
Non-sterile compounding requires what type of water if water is necessary?
purified
If an oral prescription is received, the pharmacist must read the rx back to the prescriber or their agent, unless
recorded on a voice messaging system
What is the exception to a final check?
remote automation
When must a pharmacist review each order from a decentralized AMS? Exception?
review each order before system permits access of medications - except starter doses same with remote
What is the exception to obtaining a dispensing permit?
starter doses
What is the prohibited acts under a physician-pharmacist agreement?
substitution of a chemically dissimilar drug by the pharmacist for the product prescribed by the physician, UNLESS permitted in therapy management contract
Outsourcing facilities are subject to inspection by...
the FDA
Date of fill or refill, initials of pharmacist/data-entry tech must be on what?
the patient profile, RX, OR RX record
Oral prescriptions can only be received by whom?
the pharmacist
that pharmacies cannot receive a drug product after July 1, 2015, unless
the prior owner provides it with track and trace information; the dispenser must also provide this information when transferring to a subsequent owner other than a patient.
For an assisted living facility, emergency kits cannot be made available unless
there is an RN/LPN available 24/7
What are repositories?
they receive donated drugs from drop-off sites for purposes of re-dispensing
When can the Attorney General place a drug into CI without consulting FDA?
to avoid an imminent hazard to public safety
When does the minimum necessity rule for HIPAA not apply?
treatment purposes does apply for payment purposes
T/F a full service pharmacy may conduct wholesale distribution as long as that business does not exceed 5% of annual sales
true
T/F criminal background checks are needed for designated reps and supervisors of wholesale distributors
true
How many times can a CIII, IV, V be refilled?
up to 5 times in a 6 month period from when RX WAS *WRITTEN* not filled
prescription written for valium - what can you give the patient? what if written for diazepam?
valium or dispense diazepam generic for either unless DAW
Outsourcing facilities must register with the state of Maryland as a
wholesale distributor
For second fills and other refills, CDS III-V prescription expires after how long?
within 6 months
How long do you have to notify a prescriber of an unauthorized refill (non-emergency)?
within 72 hours
Where can't a PA write for CDS substances?
within a public health facility but they can write for treatment of HIV or an ID OTHER than an STI in PHF UNLESS protocol
What must a pharmacist have in order to administer a vax?
written, *vaccine specific* protocol that meets regulatory requirements NO RX REQUIRED FOR PERSONS 18+
Can full-service and waiver pharmacies exist at same location? Under what conditions
yes - separate permits - separate pharmacists - separate inventory/record keeping
Can PHI be disclosed to a pharmacy computer vendor (or someone who performs a service on behalf of the covered entity)
yes, but need written agreement
An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a *Schedule II* controlled substance provided the following conditions are met
•(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice; •(ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription; •(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse; •(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws In MD, can issue 3 prescriptions on same day with up to a 90 day supply TOTAL (30 ds/mo)
Returning CDS drugs at pharmacy closure
•Copy of CDS closing inventory •Names, addresses, phone numbers, DEA #'s of entities to whom prescription drugs/records were transferred
Remote AMS monitoring
•Pharmacist has access to system via electronic & visual means - system must provide picture or description of drug - system just use bar code technology and electronic accounting of access by individuals and drugs removed
What if the transmission for a computer-generated RX for CDS fails?
•Prescriber may write a copy of the e-transmitted Rx and sign it. •Copy must indicate that it was originally transmitted and transmission failed •Pharmacy must check to be sure the e Rx was not received or dispensed before it dispenses the paper Rx
What do you need to record if drugs were destroyed when pharmacy is closing
•Records of date, place, and manner of destruction •Names, addresses, phone numbers of persons responsible for destruction •Name, quantity, dosage unit of each drug destroyed But most people transfer drugs back to DEA reverse distributor for the most part
Who has authority to place a drug into a schedule, place in a different schedule or remove from scheduling.
The Attorney General
Who issues permits to Wholesaler distributors?
The Board of Pharmacy
Who must the tech be registered with?
The Board of Pharmacy
Who can determine if a biosimilar can be substituted?
The FDA has the authority to determine whether a biosimilar is safe and effective and whether it might be substituted automatically for a physician's prescription for the brand name biologic
If a pharmacy wanted to change its business hours, who must be notified and within how long?
The board At least 30 days prior
Who will conduct a closing pharmacy inspection?
The board OR OSCA
What is wholesale drug distribution?
The distribution of *prescription* drugs or devices to persons other than consumer or patient
Who must initiate therapy management contracts?
The physician