PA MPJE Made Easy
What needs to be recorded when Schedule A poison is sold?
- date of sale - name, address, signature of buyer - name and quantity of poison sold - statement of the purchaser of the purpose - name of registered pharmacist dispenser
Compunder cannot distribute more than how much of total prescriptions dispensed or distributed by the pharmacy? If they do, what is needed?
5%; need memorandum of understanding between the pharmacy's state and the FDA
PA regulations place what time limit in which CII script must be filled from the date of issue?
6 months
members of the state board of pharmacy serve lasting how long? How many terms are allowed?
6 year terms with no more than 2 consecutive terms
Once a patient acknowledges the NOPP, how long must record of this be kept?
6 years
Record of disclosures must be maintained for how long?
6 years
How long is a pharmacy internship valid?
6 years from the date of issue, but is invalid if enrollment at school of pharmacy ceases
If a patient requests an accounting of disclosures, the pharmacy must respond within what time frame?
60 days
If an order on DEA 222 form cannot be filled completely, how long does the supplier have to supply the balance?
60 days
If waiver is approved to allow pharmacist to manage more than 1 store at a time, how long is this waiver good for?
60 days in addition to the 15 days that are normally allowed to find a replacement
Physicians must countersign and date verbal orders to physicians assistants or CRNPs within what time frame?
7 days
Documentation on a patient's chart by physician assistant's shall be countersigned by supervising physician within what time frame, how?
7 days with an original signature and date by the licensed physician
Medical records for a resident of LTCF need to be retained how long?
7 years following resident's discharge or death
If balance of partially filled CII script is not filled within ______ hours, the pharmacist must do what?
72 hours; notify prescriber either to get a new prescription for the balanced owed or to let him/her know that the Rx was not completely filled (i.e. if patient indicates they don't need the balance)
PPPA requires that child resistant caps are such that _____% of children under 5 cannot open and ____% of adults can open.
80% of children; 90% of adults
Individual practitioner may issue multiple CS prescriptions authorizing the patient receive total of what day supply?
90 day supply (provided conditions are met)
After january 1, 2015 when systems were required to track drugs under PDMA, what must be in place 10 years after?
All partners (mfg, wholesaler, repackager) must have fully electronic, interoperable track and trace program
What is Title I of the DQSA?
Compounding Quality Act
Pharmacists are equally responsible/liable as prescribing practitioner when filling CS prescription. What is this called?
Corresponding Responsibility Doctrine
What form needs to be filled out by *reverse distributor* if CS are being destroyed?
DEA 222 form when getting from pharmacy; DEA form 41 once drugs are destroyed
What form is used to fill out for initial registration of CS activity with DEA?
DEA 224 application form
What is the electronic system to order controlled substances?
DEA Controlled substances ordering system (CSOS)
Who needs to be notified if it is determined if any controlled substances are stolen or lost? What format? What time frame?
DEA Field Division Office; notify IN WRITING within 1 business day of discovery of theft or loss (usually recommended by fax)
What form is required for schedule II controlled substances?
DEA form 222
If pharmacy needs to request assistance from the Special Agent in Charge in regards to destroying CS, what form do they submit?
DEA form 41
What does an Order to Show Cause mean?
DEA is required to provide you an opportunity to defend yourself and with the Order is asking you to give a good reason why the DEA should not revoke/suspend your license
If individual registrant for DEA CS registration dies or if registrant ceases legal existence or discontinues business, what needs to be happen?
DEA needs to be notified and registration terminated
What agency is responsible for Controlled Substance Act? What regulation is this under?
DEA; 21 CFR, Chapter 1300
When did the Combat Methamphetamine Epidemic Act go into effect? Which president?
March 9, 2006; President Bush signed into effect
What is the Controlled Substance Registration Protection Act?
Enacted to protect DEA registrants like pharmacies
What agency is responsible for Food Drug & Cosmetic Act? What regulation is this under?
FDA; 21 CFR
Who assigns NDC number? For what purpose?
FDA; for convenience purposes
Who regulates the advertising of OTC drugs?
FTC
Does offer to counsel have to be made orally?
NO; if they come in to the pharmacy, the offer may be made orally, but written offer may be substituted in certain situations (like if the patient is hearing impaired)
Are controlled substances inventories allowed to be stored as part of central record keeping?
NO; maintain at the registered location
Can you throw away DEA 222 forms completed in error?
NO; need to store
Can pharmacy dispense CS before they are registered with DEA?
NO; no person may engage in activity for which registration is required until application for registration is granted and certificate of registration is issued
OTC products can seek approval/marketing through what methods?
New Drug Application, Abbreviated New Drug Application (ANDA), or under an OTC monograph
Can CIIs be refilled?
No
If a search warrant is served on a pharmacist for an inspection, can it be refused?
No
Is the name of a collaborating prescription required on a prescription written by a CRNP?
No
Schedule I drugs have _________________ medical use.
No accepted
Combat Methamphetamine Act includes products containing what? What are these collectively referred to as?
ephedrine, pseudoephedrine, phenylpropanolamine (which has been withdrawn from the market) (collectively referred to as Scheduled Listed Chemical Products)
Schedule III, IV, and V drugs can be ______________ unless what?
estimated; unless the original container from the manufacturer contained more than 1000 tablets or capsules in which case an exact count must be taken
Pharmacy permits are renewed when?
every 2 years in odd-numbered years
When are pharmacist licenses renewed?
every 2 years on even-numbered years
Certification of the authority to administer injectables needs to be renewed how often?
every 2 years with the license to practice pharmacy
How often are pharmacies required to register for controlled substance activity? With who?
every 3 years (triennially) with Attorney General
___________ ________ of cancer drug needs to be accounted for in record keeping for Cancer Drug Repository Program
every dose
Schedule I and II drugs need to be counted _____________
exactly
What did the Drug Addiction Treatment Act of 2000 do?
expanded the treatment of opiate addicts beyond the clinic in that it allows the use of Buprenorphine (Subutex) and Buprenorphine & Naloxone (Suboxone) to be dispensed in a retail pharmacy for the treatment of opiate addiction
Waxman Hatch Amendment also did what for brand name drug manufacturers?
extended the patent life for the time of the FDA approval process for the brand name drug and granted exclusivity rights in certain cases for brand name manufacturers (ie 3 year exclusivity is granted for any new uses developed by the pioneer brand name manufacturer for an existing drug whose patent is expiring)
What does the "no blood, no drug" program mandate?
all patients must have weekly CBC done; once weekly for 6 months, then once every 2 weeks for 6 months, then after 1 year can step down to once every 4 weeks
Long Term Care Patient Access to Pharmaceuticals Act does what?
allows eligible patients in LTCF to continue to receive low cost drugs from VA
What does biosimilar subsitution bill do?
allows pharmacists to substitute a biological product for a prescribed biological product
What does the Ryan Haight Online Pharmacy Consumer Protection Act do? What does it mean for pharmacies?
amends the CSA to prevent the illegal distribution of CS on the internet; pharmacies must get a modification of existing DEA registration to allow operation of an online pharmacy and adds reporting and disclosure requirements
Again, methadone may only be dispensed in retail setting for what?
analgesic purposes
What insulins require a prescription?
analog insulins including lispro, aspart, glulysine, glargine, degludec, and detemir
Electronically transmitting a prescription does not include sending it by what means?
fax or phone
What is the requirement for obtaining a pharmacy permit if the applicant (individual or partnership) is not a pharmacist?
can be no guilty pleas or nolo contendere related to practice of pharmacy or moral turpitude
Judge can issue AIW for valid public interest. What does this mean?
can simply be that period of time has elapsed since last inspection or that the pharmacy is ordering more CS than similar pharmacy
To be considered for donation, cancer drug must be accompanied by what?
cancer drug repository donor form that is signed by the entity's authorized representative and states that to the best of the donor's knowledge the donated drug has been properly stored and has never been opened, used, tampered with, adulterated, or misbranded
If tax free alcohol is used in preparation of a compound for patient (in the hospital setting), can the patient be charged for the alcohol? What can they be charged for?
cannot charge for the alcohol; can charge for any medicines compounded on the premises and dispensed to patients for use on the premises
What are the potential toxicities from hazardous drugs?
carcinogenicity, teratogenicity, developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity
DEA 222 Order forms for __________________, __________________, and _____________________ shall contain only these substances
carfentanil, etorphine hydrochloride, diprenorphine
If central fill pharmacy is contracted with private, common, or contract carriers to transport filled prescriptions to retail pharmacy if loss occurs, who is responsible for reporting? What form?
central fill pharmacy is responsible; DEA form 106
Which type of pharmacy doesn't have to conform to minimum space requirements? Why not?
central processing center; because not involved with dispensing activities
In order to be qualified to prescribe buprenorphine, physician must have what in addition to X DEA?
certification in Addiction Medicine or have completed 8 hours of specified CE requirements
What are the requirements for FDA inspection? (the "reasonables")
conduct at a reasonable time in a reasonable manner and be reasonably limited (during normal business hours with minimal interruption)
If drug is exposed to conditions of fire, water, or extreme temperature in instances it is also classified as what? Under what Act is this done?
considered adulterated if exposed to extremes; under the Controlled Drug Device and Cosmetic Act
In addition to being registered 30 days prior, pharmacies must do what before engaging in internet pharmacy?
contact respective boards of pharmacy for all states they wish to do business in at least 30 days prior
Fluoride OTC preparations must be in CRC if what amount?
containing more than 50 mg of elemental fluoride per package
Naproxen OTC preparations must be in CRC if what amount?
containing the equivalent of 250 mg in a retail package
Tamper Evident Packaging Act was enacted in response to what?
contamination of Tylenol capsules with cyanide in 1982
Prescription monitoring law created what?
controlled substance database called the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP)
If DEA 222 order form is filled out and lost and new one is properly executed, where do all the copies go?
copy of the statement is attached to copies 1 and 2 and those are sent to supplier, copy 3 is retained in the pharmacy
If pharmacist receives a prescription for Medicaid that is non-compliant with requirements, pharmacy should do what?
correct it by calling the prescriber for a phoned in, electronic, or faxed prescription
Most CV substances are what?
cough suppressants or antidiarrheals
What did the Durham Humphrey Amendment do?
created a statutory distinction between prescription and OTC drugs
New DEA policy on agents of prescribers for CS does what what?
creates a vehicle (written agent agreement) for individuals acting outside of employee/employer relationship to be considered agents of the prescriber
FDA only needs to present what at time of regular inspection?
credentials and Notice of Inspection
It is important to remember that even if practitioner issues multiple CII prescriptions with different "do not fill until dates" which date is the same on all?
date of issue
need to record what relative to VIS?
date of publication of the VIS and the date and to whom it was provided
If an entire book of DEA 222 order forms is lost or stolen and the pharmacy is unable to state the serial numbers of the order forms, what needs to be reported to DEA?
date or approximate date of issuance of the order forms
If theft or loss of DEA 222 order forms occurs and supplier can't state the serial numbers of the lost/stolen order forms, what do they have to report to DEA?
date or approximate date of receipt thereof and the names and addresses of the purchasers
Oral order in institutional setting needs to include what?
date, time, full signature of the person taking the order and shall be countersigned by the practitioner within 24 hours
If CS registrant has license suspended or revoked what must they do?
deliver the Certificate of Registration and all 222 forms to the DEA and at the direction of the DEA either deliver all controlled substances to the DEA or keep them under seal
What are exceptions to the tamper resistant packaging requirements?
dermatologicals, dentifrices, insulin and lozenges
Spilled or damaged controlled substances that are recoverable are required to be destroyed how and reported how?
destroy using accepted destruction method, report on DEA 41 form
Drugs that are not accepted under cancer repository program must be what?
destroyed or disposed of
Electronic orders on DEA CSOS must be signed how?
digital signature issued by a Certification Authority (CA) run by the DEA
Adequate directions for use means what?
directions under which the layman can use a drug safely and for the purposes for which it is intended
Approved program provider shall provide upon request what to the board in regards to an impaired professional? In what situations would this happen?
disclose consultant information; shall occur in case of impaired professionals who enter into agreement with the board, impaired professionals who are the subject of board investigation of disciplinary proceeding, impaired professionals who voluntarily enter a treatment program other than described above, but who fail to complete the program successfully or adhere to an after-care plan developed by program provider
If in the opinion of the consultant (after consulting with provider), an impaired professional has not made satisfactory progress in treatment program, then what?
discloses this to board and board has to institute proceedings to determine if stay of enforcement of suspension or revocation of license shall be vacated
minimum necessary standard with PHI does not apply to what?
disclosures for treatment purposes, disclosures to the patient themselves, or to disclosures made pursuant to a written authorization from the patient
What is maintenance treatment of detoxification?
disepensing of an opioid agonist treatment medication at stable dosage levels for a period in excess of 21 days in the treatment of an individual for opioid addiction
What does the term "detoxification treatment" mean?
dispensing of an opioid agonist treatment medication in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of an opioid drug and as a method of bringing the individual to a narcotic drug free state within such period
What is the definition of label? What is the difference with this and labeling?
display of written, printed, or graphic matter upon the *immediate container* of any article; labeling means all labels, and other written, printed or graphic matter upon any article or any of its containers or wrappers or accompanying such article (including package insert)
Failure to enter agreement where impaired professional is in approved treatment program means what for professional license?
disqualify professional from impaired professional program and activate immediate investigation and disciplinary proceeding by the board
Instead of tamper evident packaging, what can the package have?
distinctive by design (i.e. the packaging cannot be duplicated with commonly available materials or processes; like an OTC inhaler)
Individuals applying for initial licensure must do what no later than 12 months after obtaining initial license?
document at least 2 hours of CE in pain management, identification of addiction, and at least 2 hours of education in practices of prescribing or dispensing opioids (these can be part of individuals education program or CE program)
If patient or caregiver refuses counseling, what does pharmacist need to do?
document the refusal including name or initials of the pharmacist or designee noting the refusal by either notating on prescription, patient profile, on electronic records of the pharmacy, or writing signed by caregiver
OCR is specifically checking what as part of ensuring compliance?
documentation of any breach notification
HIPAA applies to what covered entities?
health care providers, health plans, health care clearinghouses
Schedule I drugs have what physical and psychological dependence?
high in both
Schedule II drugs have what physical and psychological dependence?
high physical, severe psychological
If drug is returned to stock, it shouldn't be mixed with what?
don't mix with stock bottles of different lot numbers or with different expiration dates
The pharmacy may not cancel an item on its own by doing what?
drawing a line and marking the item cancelled
What does the Food Drug and Cosmetic Act regulate?
drug quality (no new drug can be marketed until proven safe and approved by FDA; also requires labels to have adequate directions for use)
What is a PDR?
drug review; pharmacist must review a profile of the patient prior to dispensing the medication to the patient or caregiver
Compounds cannot be compounded with what kinds of substances?
drugs that the FDA has withdrawn from the market for safety or efficacy reasons
Expedited approval of drugs by FDA is for what?
drugs that treat serious life threatening illnesses and provide a meaningful therapeutic advantage over existing treatments (like AIDS drugs)
DEA recommends that the original signed agency agreement with agent to the prescriber be kept by prescriber how long? Copy should also be provided to who?
during the term of the agency relationship and for a reasonable period after termination or revocation; also provide to practitioner's designated agent, the agent's employer if it isn't the prescriber and any pharmacies that regularly receive communications from the agent pursuant to the agreement
Separate registrations are required for ________ pharmacy owned or operated by the same firm
each
Pharmacist who allows license to lapse must also do what in terms of CE?
earn required number of CE credits he/she would have been required to earn had he/she held an active license
Syringes and needles are permitted to be sold with or without script?
either with or without
Participation in cancer drug repository program requires _______________ _______________________
elaborate recordkeeping
Under collaborative agreement both physician and pharmacist must have access to what? This must comply with what?
electronic medical records; must ocmply with HIPAA
Patients can receive copies of their health information in what format?
electronic or paper (whatever the request)
When prescription is received electronically, how does it need to be stored?
electronically and with all annotations
How long do records on the CSOS have to be maintained?
electronically for 2 years
Why is there a REMS program for isotretinoin?
eliminate fetal exposure to isotretinoin through special restricted distribution program approved by FDA
In December 2014, FDA changed what in prescription drug labeling in regards to pregnancy and breastfeeding?
eliminated pregnancy categories A, B, C, D, and X and revised so that more complete information about the effects of medicines in pregnancy and breast feeding
LTCF must have at least one what?
emergency kit
Pharmacy may place an ____________ ______ with CS in a non-DEA registered LTCF if what?
emergency kit; if state agency or regulatory authority specifically approves the placement
What CS communication may not be delegated to an authorized agent to a prescriber?
emergency oral communication of CII prescription
Prescriber may authorize who to transmit a prescription for a CS?
employee/non-employee agent (under new law)
If supplier does not have item ordered in stock on DEA 222 form, they can also do what?
endorse the reverse side of the DEA 222 order form to another supplier if they don't have it
A pharmacist who is employed by a physician under collaborative agreement for the purpose of management of drug therapy may not do what?
engage in retail dispensing within the context of employment
Why was standing order for naloxone created?
ensure that all persons who are permitted under act 139 to receive naloxone are able to access and effectively use the medication
Before DEA can suspend or revoke a CS registration, they first have to do what?
issue an Order to Show Cause
What is a class III drug recall?
issued when the product is not likely to cause adverse health effects
What is a Class II drug recall?
issued when the product may cause temporary or medically reversible adverse effects, but the probability of serious health effects is remote
What is a Class I drug recall?
issued when there is a possibility that the product will cause serious adverse health effects or death
if drug is rated B it means what?
it cannot be substituted either with an A drug or another B drug
After NOPP is provided, pharmacy can use and disclose PHI without consent or authorization as long as what?
it is for the purposes of treatment, payment, or health care operations
The most important thing to remember with release of PHI is what?
it's okay to do as long as there is signed patient authorization; NEVER share PHI without signed authorization
Which part of form 222 does the purchase keep? What do they do with the other copies?
keep copy 3 and mail copy 1 and 2 to supplier
If drug cannot be returned to stock bottle, what can be done?
keep in the vial or container in which they have been repackaged
Pre-packed medications need to be recorded how?
keep log in pharmacy with label information and the date and quantity pre-packed
Inventory records for CII must be _______ _______________
kept separately
The 2 year retention rule for DEA records is based on what date?
last entry made (i.e. for 222 forms it's not from the date of order, but from the date that the packages were received and the date received on copy 3)
Licensed pharmacist or permit holder may not display a current certificate, license, or permit, or renewal for any pharmacist who is not what?
lawfully employed at the location
GMPS apply to who?
manufacturers, not pharmacies unless pharmacy engages in activities deemed to be manufacturing (like large scale compounding)
Bar coding requirements apply to who?
manufacturers, repackers, relabelers, and private label distributors
What is the quintessential example of when an authorization would be required for release of PHI?
marketing
What are penalties upon conviction for burglary or robbery of pharmacy?
maximum $25,000 fine and/or 20 years imprisonment
What are penalties if a dangerous weapon was used to carry out the crime against the pharmacy?
maximum $35,000 fine and/or 25 years imprisonment; if death resulted from the crime maximum $50,000 fine and/or life imprisonment
What are the refill limits on CIII-CV prescriptions?
maximum 5 refills or over a period of 6 months, whichever comes first to the extent allowed by the physician
If a patient or caregiver does not come into the pharmacy, how does the offer to counsel have to be made?
may be made by telephone, by the delivery person, or by a written offer including a toll-free number to reach the pharmacy
A nonresident pharmacy may not engage in what with the commonwealth unless what?
may not engage in business of shipping, mailing or delivering legend devices or legend drugs unless has been issued certificate of registration by the board and has paid the fee established by the board
Beyond use dating of 1 year for unit dose pharmaceutical items is based on what storage per USP?
mean temperature of 25 degrees and using material other than PVC
REMS programs may include what components?
med guides, communication plans, and/or elements to assure safe use (ETASU)
If board has probably cause, they have the authority to compel pharmacist to submit to what?
mental or physical examination by physicians or psychologists approved by the board
For addicts, treatment with methadone for detox/addiction can only be administered where?
methadone clinic
What are some of the current technologies in place to ensure prescription is tamper resistant?
microprinting, serial numbers on prescriptions, coin rubs, watermarks, specialized paper to detect erasure, heat sensitive paper that will reveal a picture upon the touch of a finger, the work void showing if the Rx is copied, and warning messages that describe security features
Emergency kit should contain what?
minimum quantity and categories based on immediate needs of the facility
If a patient package insert isn't provided, it is considered what?
misbranding
Any person who violates the unlawful acts (Section 8) is guilty of what? What are the penalties?
misdemeanor; imprisonment for not more than 1 year and fine of no more than $5000
Schedule III drugs have what physical and psychological dependence?
moderate physical, high psychological
How do registrants become authorized to establish CS disposal program?
modify DEA registration
Pre-packing needs to be done under supervision of who?
R.Ph.
Applicants for NAPLEX/MPJE should review what for the exams?
Registration bulletins for the two exams on the NABP website
What is the REMS program for thalidomide (Celgene) called?
S.T.E.P.S.
If Special agent in charge authorizes blanket approval for destruction of CS, what may also go with this?
SAC may place such conditions as he deems proper on the disposal of CS including method and frequency and detail of reports
Where is the list of infarctions for which board of pharmacy can revoke, suspend, or refuse the license of a pharmacist?
Section 5 of Pharmacy Act
Where is the list of unlawful acts that result in criminal penalties in addition to Board penalties?
Section 8 of Pharmacy Act
What does the Final Rule for DIsposal of CS implement?
Secure and Responsible Drug Disposal Act of 2010
If lost/stolen DEA 222 order forms are subsequently recovered or found, who needs to be notified and when?
Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located; notify immediately
What are the labeling requirements under tamper evident packaging act?
need to label to alert consumer to tamper resistant features used; placed so that it will be unaffected if a tamper resistant packaging feature is breached or missing
If pharmacy has to use or disclose PHI for any purpose other than TPO, what needs to be done?
need to obtain written authorization from the patient before PHI is used or disclosed
If DEA CS registration needs to be modified (change of address, addition of schedules), what needs to happen?
notify DEA in writing
IF a DEA CSOS order cannot be filled, what must the supplier do?
notify purchaser and provide statement as to the reason (like impoperly prepared or altered)
PA law requires that anyone in possession of distressed drugs do what?
notify the Dept of Health so that items may be inspected to determine their fitness for use or consumption
TIRF medicines should only be dispensed for what use with what?
outpatient use with evidence/documentation of safe use conditions
Ipecac syrup can be available without prescription if in what quantity ?
packaged in quantity of 1 fluid ounce (30 milliliters)
Patients also have the right to restrict disclosures about their treatment to a health plan if they have done what?
paid in full out of pocket
If giving vaccine to child <18 need what?
parenteral consent
Who can make a blanket waiver request for non CRC?
patient ONLY; or on behalf of all members of a family by the head of household
Any patient communication that encourages the purchase or use of a product or service or any activity that involves the sale of PHI also requires what?
patient authorization (previously most written communications were considered treatment and didn't need authorization)
Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for ______________ _______
patient use
Pharmacist is never permitted to make what changes to a CS prescription?
patient's name, CS prescribed (unless generic substitution) or prescriber's signature
Collaborative agreement should remain in effect for how long?
period not to exceed 2 years upon conclusion of which or sooner the parties shall review the agreement and make determination as to renewal, necessary modifications or termination
Prescriptions that have not been picked up or delivered to the patient should be assess for RTS when?
periodically by the pharmacist
Under medicare, if pharmacy is to work with a LTCF, they must be able to provide what?
pharmaceutical services (procedures that assure the accurate acquiring, receiving and to employ the services of a licensed pharmacist to meet the needs of each resident
What are satellite pharmacies?
pharmacies that provide specialized services for the patients of an institution and which is dependent on the central pharmacy for administrative control, staffing, and drug procurement
All floor stocks shall be controlled by who? and any area where drugs are stored shall be periodically checked by who?
pharmacist
Pharmaceutical service in a hospital needs to be directed by who?
pharmacist
If subsequent investigation of CS determines that nothing was lost or stolen, then what needs to be done?
pharmacist doesn't need to complete DEA form 106, but does need to notify DEA in writing of this fact in order to resolve the initial report and explain why no DEA form 106 was filed regarding the incident
Who can accept deliveries from donors or designees of donated cancer drugs?
pharmacist licensed for the program
Before transmission of any original or new prescription or medication order to AMS can be made, what must happen?
pharmacist must approve it
Before dispensing a faxed CII prescription, what must happen?
pharmacist must generally receive the original signed Rx for review
If computer system is capable, what is required (what must pharmacist do) to show documentation that any CS refill information entered in the computer is correct?
pharmacist must generate printout of each day's CS prescription refill data, verify, date, and sign it within 72 hours of the time the refill was dispensed
If physician fails to provide hard copy of emergency CII script within designated time frame, who should be contacted?
pharmacist needs to contact DEA
Who is not automatically eligible to complete DEA 222 form?
pharmacist or pharmacy manager; must be a completed power of attorney allowing you to do that
Who's responsibility is it to know when a drug becomes newly scheduled?
pharmacist's responsibility
Who can access ABC-MAP? What can it help reduce?
pharmacists and other authorized healthcare providers can access the database to recognize diversion and reduce doctor shopping
Act 139 also provides what in terms of immunity?
pharmacists immunity from any criminal or civil liability or any professional disciplinary action for prescribing or dispensing naloxone or any outcomes resulting from the eventual administration of naloxone
What is the new CE requirement when it comes to opioids?
pharmacists must obtain 2 of the 30 hours of CE in the area of pain management, ID of addiction, or prescribing or dispensing of opioids
Who is allowed to dispense medications for residents of LTCF?
pharmacists or licensed physician for residents under their care
If pharmacy determines that an unfilled (but completed) DEA 222 order form is lost, what happens?
pharmacy executes another order form
A pharmacy can be held liable for who? Business associates may be held liable for who?
pharmacy liable for business associates; business associates liable for subcontractors
Besides maintenance in response to failure, pharmacy that uses AMS also needs program for __________________ ________________
preventative maintenance (of the system)
Physicians prescribing buprenorphine must also have capacity to do what?
refer patient's for necessary ancillary services (like psychosocial therapy)
Need to ensure prescription is written by a prescriber acting within what?
scope of practice (i.e. dentist can't write for birth control)
What does DEA CSOS allow for?
secure electronic transmission of controlled substance orders without supporting DEA form 222
How do controlled drugs need to be stored?
secure, susbtantially constructed locked cabinet or may be dispersed through stock in such a way as to obstruct theft or diversion
If retail pharmacy installs and operates automated dispensing system at a LTCF what do they need to have?
separate registration at the location of each LTCF at which automated dispensing systems are located
Drugs received in Cancer Drug repository program need to be stored where?
separately from the rest of the participating pharmacy's stock
What is Phase II of clinical testing in humans?
studies performed on a limited number of people (100-300) who actually have the disease to determine efficacy
What is Phase III of clinical testing in humans?
studies performed on larger scale of affected individuals (1000-3000)
If results of Phase III clinical trial is favorable, what will the manufacturer do?
submit NDA to the FDA for consideration of new drug
When a pharmacy owner wishes to change location of a pharmacy or establish a new pharmacy, they do what? What will be the course afterwards?
submit plans to the Board for prior approval; board will notify the applicant of approval or disapproval within 90 days
Subutex is typically used for ___________ _________________ and Suboxone is used for ________________ _______________
subutex for initial treatment, suboxone for maintenance treatment
Definition of pharmacy internship?
supervised practical experience required for licensure as a registered pharmacist
If purchaser does not take custody of controlled substance order from online pharmacy and instead returns it to supplier, then who is responsible for reporting to DEA if shipment is lost/stolen?
supplier
When all or part of an in-transit shipment of controlled substances from online pharmacy fails to reach destination, who is responsible for notifying DEA?
supplier
Who can void an electronic DEA CSOS order? what needs to be done?
supplier can void; needs to notify purchaser of voiding
If DEA CSOS order is not filled, who has to maintain record?
supplier does not have to, purchaser must retain electronic copy of the voided order
What does supplier do with copies 1 and 2 of DEA 222 order form?
supplier keeps copy 1 and sends copy 2 to DEA
If a DEA CSOS order is partially voided by a supplier, what must be done?
supplier must indicate in the linked record that nothing was shipped for each item voided
If an entire order of DEA CSOS order is voided by supplier, what must be done?
supplier must make an electronic copy of the order and indicated void on the copy and return it to the purchaser
If DEA 222 order form that was filled out and then lost is subsequently receive by the supplier, what should be done with it?
supplier shall mark upon the face "not accepted" and return copies 1 and 2 to the pharmacy which attaches it to copy 3 and the statement
Prescriber must do what for pharmacist as part of clozapine REMS?
supply the pharmacist with a current blood work result (drawn within 7 days irrespective of monitoring frequency) and including a CBC and ANC prior to dispensing
If schedule II substances are in what form they become schedule III?
suppository form
Each commercial container of CS will have printed what on the bottle?
symbol on label designating what schedule the CS is listed
By January 1, 2015 under PDMA all partners (mfg, wholesaler, repackagers) were required to have what?
systems in place to quarantine, investigate, and notify DEA of any suspect drug product
Why is thalidomide tightly controlled by the FDA?
teratogenic effects
What triggered the Kefauver Harris Amendment?
thalidomide disaster with pregnant patients
Presence of NDC number does not indicate what?
that a drug has received an NDA approval
If drug recall is ordered and there is no lot number (i.e. if it is a RTS bottle, or repackaged) what should be assumed?
that it is included in the recall
If the supplier to whom a DEA CSOS lost order was directed subsequently receives the first order, the supplier must then indicate what?
that it is not accepted and return it to the purchaser; purchaser must link the returned order to the record of that order and the statement
Renewal applications for authority to administer injectables needs to show what?
that pharmacist has completed a minimum of 2 of the 30 required hours of continuing education in this area of practice and current CPR certification
What does the Dietary Supplement Health and Education Act mandate?
that the FDA regulate dietary supplements as a special type of food, rather than a drug
What claims does the Dietary Supplement Health and Education Act NOT allow manufacturers of dietary supplements to make?
that the dietary supplements diagnose, treat, cure, or prevent disease
The letter "L" in an optometrist's license indicates what?
that the optometrist may not prescribe drugs
Seller must assure what when selling poison to a buyer?
that they are aware of the poisonous character of the substance in either schedule and that they are using it for legitimate purpose
Copies of a child's immunization record can be shared with who upon parent's request? Does it require signed authorization?
the child's school; does not require signed authorization but should be documented in the child's record
Newly scheduled drugs must be inventoried when?
the day they become scheduled and then again with the next scheduled biennial inventory
If pharmacy engages with central fill pharmacy, who is responsible for making the offer to counsel?
the delivering pharmacy
If expiration date says December 2016, what day does it expire?
the last day of the month; i.e. December 31st
Who is responsible for removing expired, adulterated, and misbranded drugs from stock?
the pharmacist manager
Who is allowed to counsel?
the pharmacist only!
Board may defer or dismiss any type of corrective action against an impaired professional so long as what?
the professional is progressing satisfactorily in an approved treatment program
Substitution is only allowed if drugs are _______________ __________________
therapeutically equivalent (A drugs can be substituted for each other)
What changes can pharmacist make to CII prescription?
unclear; state law is in charge of this, but PA law is silent on this issue
Oral orders for medications in institution should be accepted only when?
under urgent circumstances when it is impractical for the orders to be given in written manner by responsible practitioner
Each pharmacy requires it's own permit unless what?
unless it is a satellite pharmacy
If issuing multiple CII prescriptions, the individual practitioner must indicate what on each script?
unless it is being filled immediately, must indicate the earliest date on which a pharmacy may fill each prescription (i.e. Do not fill until......)
Institution may not be considered for a pharmacy permit unless what?
unless the pharmacy in that institution is open a minimum of 20 hours per week under the supervision of a registered manager
Pharmacies who have what may apply to participate in the Cancer Drug Repository Program?
unrestricted permit
CSOS digital certificate is valid until when?
until DEA registration under which it is issued expires or until the CSOS CA is notified that the certificate should be revoked
What are the civil penalties if one is non-compliant with HIPAA?
up to $100 per violation and up to $25,000 per person in any calendar year for the improper disclosure of PHI
If an individual uses PHI under false pretenses what can the penalties be?
up to $100,000 and up to 5 years in jail
If covered entity uses PHI for "commercial advantage, personal gain, or malicious harm" what could the penalties be?
up to $250,000 and/or 10 years in prison
What are the penalties for a person who knowingly permits or uses or discloses PHI improperly?
up to $50,000 fine and up to 1 year in jail
Colestipol powder form is exempt from PPPA in what amount?
up to 5 grams in a packet
Again, what are the refills are allowed on CIII-CV scripts?
up to 5 refills in 6 month period from the date of the prescription
Meds that have been returned to stock and lack original lot numbers or expiration dates should only be dispensed in what time frame?
up to 6 months from the date they were first prepared for dispensing
Failure to return license or registration after revocation or suspension can result in what?
upon conviction, shall be a misdemeanor of the third degree
222 Order forms are requisitioned how?
use DEA 222a form and send to Registration Unit of DEA in Washington DC
Prescriber has the authority to give more than 7 days supply of opioid to a child as long as what?
used to stabilize the minor's acute condition, and the medical condition is documented in the minor's record and a reason listed why a non-opioid would not be appropriate (another exception is if it is for pain associated with cancer, palliative, or hospice care)
Two piece hard gelatin capsules must be sealed how?
using an acceptable tamper-evident technology
If patient refuses to sign authorization to release PHI then pharmacy is prohibited from what?
using or disclosing the information, and the pharmacy may not condition treatment on the receipt of an authorization (can't refuse treatment)
A pharmacy must make reasonable effort to limit the use or disclosure of PHI by doing what? What is this called
using the minimum amount required to accomplish the purpose of the use or disclosure; called minimum necessary standard
What is a communication plan?
utilize various methods of dissemination like direct mailings, communications via professional societies, etc. to communicate risk and REMS related information to health care providers
What needs to be given prior to vaccine?
vaccine information statement (VIS)
Patients will receive what as part of the STEPS program?
visual aids including a videotape, written material, verbal counseling about benefits and risks and the importance of not becoming pregnant during therapy
Upon receipt of cancer drug from donation, must do what?
visually inspect to determine if they were previously adulterated or misbranded
If pharmacist does not notify DEA after physician fails to deliver emergency CII script hard copy, what can happen?
voids the authority of the pharmacy to accept emergency oral orders for schedule II substances
Participation of pharmacist and physician in collaborative agreement is ______________
voluntary
In addition to requirements to be a qualified physician for buprenorphine requirements, practitioners also need to request what?
waiver from CSAT, which notifies DEA of all waiver requests to become DATA waived practitioners
What schedule drug is methamphetamine (Desoxyn)?
Schedule II
What schedule drug is methylphenidate (Ritalin, Concerta)?
Schedule II
What schedule drug is morphine?
Schedule II
What schedule drug is nabilone (Cesamet)?
Schedule II
What schedule drug is oxycodone (Tylox, Percocet, Percodan)?
Schedule II
What schedule drug is oxymorphone (Opana)?
Schedule II
What schedule drug is pentobarbital (Nembutal)?
Schedule II
What schedule drug is secobarbital (Seconal)?
Schedule II
What schedule drug is tapentadol (Nucynta)?
Schedule II
What schedule drug are anabolic steroids?
Schedule III
What schedule drug is Xyrem (gamma hydroxybutyric acid) sodium oxybate?
Schedule III
What schedule drug is buprenorphine (Subutex)?
Schedule III
What schedule drug is buprenorphine/naloxone (Suboxone)?
Schedule III
What schedule drug is codeine/ASA?
Schedule III
What schedule drug is dronabinol (Marinol)?
Schedule III
What schedule drug is fiorinal/codeine?
Schedule III
What schedule drug is paregoric?
Schedule III
What schedule drug is tylenol/codeine tablets?
Schedule III
WHat schedule drug is clorazepate (Tranxene)?
Schedule IV
What schedule drug is alprazolam (Xanax)
Schedule IV
What schedule drug is butorphanol (Stadol)?
Schedule IV
What schedule drug is carisoprodol (Soma)?
Schedule IV
What schedule drug is chloral hydrate (Noctec)?
Schedule IV
What schedule drug is chlordiazepoxide (Librium)?
Schedule IV
What schedule drug is clonazepam (Klonopin)?
Schedule IV
What schedule drug is diazepam (Valium)?
Schedule IV
What schedule drug is eszopiclone (Lunesta)?
Schedule IV
What schedule drug is ethychlorvynol (Placidyl)?
Schedule IV
What schedule drug is flurazepam (Dalmane)?
Schedule IV
What schedule drug is halazepam (Paxipam)?
Schedule IV
What schedule drug is lorazepam (Ativan)?
Schedule IV
What schedule drug is mazindol (Sanorex)?
Schedule IV
What schedule drug is midazolam (Versed)?
Schedule IV
What schedule drug is modafinil (Provigil)?
Schedule IV
What schedule drug is oxazepam (Serax)?
Schedule IV
What schedule drug is pentazocine (Talwin)?
Schedule IV
What schedule drug is phenobarbital?
Schedule IV
What schedule drug is temazepam (Restoril)?
Schedule IV
What schedule drug is tramadol (Ultram)?
Schedule IV
What schedule drug is triazolam (Halcion)?
Schedule IV
What schedule drug is zaleplon (Sonata)?
Schedule IV
What schedule drug is zolpidem (Ambien)?
Schedule IV
WHat schedule drug is lomotil?
Schedule V
What schedule drug is Actifed/Codeine?
Schedule V
What schedule drug is Robitussin AC?
Schedule V
What schedule drug is Tuss-Organidin NR?
Schedule V
What schedule drug is novahistine DH?
Schedule V
What schedule drug is novahistine expectorant?
Schedule V
What schedule drug is phenergan VC/codeine?
Schedule V
What schedule drug is phenergan/codeine?
Schedule V
What schedule drug is pregabalin (Lyrica)?
Schedule V
What schedule drug is tylenol/codeine liquid?
Schedule V
Optometrist authorized to prescribe medications for glaucoma is distinguished how?
"G" in license number
What is the clozapine REMS program called?
"No blood, no drug" program
Every pharmacy needs to post a sign stating what to notify patients of generic substitution?
"PA LAW PERMITS PHARMACISTS TO SUBSTITUTE A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG OR AN INTERCHANGEABLE BIOLOGICAL PRODUCT FOR A BRAND NAME DRUG UNLESS YOU OR YOUR PHYSICIAN DIRECT OTHERWISE."
NOPP must contain what statement on the face of the document?
"This notice describes how medical information about you may be used and disclosed and how you can get access to this information, please review it carefully"
What is the additional online statement that must be posted on online pharmacy's home page?
"online pharmacy is obligated to comply fully with the Controlled Substances Act and DEA regulations. As part of the this obligation, this online pharmacy has obtained modified DEA registration authorizing it to operate as online pharmacy. In addition, this online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation in accordance with section 309 of the CSA (21 USC 829), or a medical evaluation vial telemedicine in accordance with section 102 (54) of the CSA)"
What is the minimum amount of liability insurance a licensee who engages in MTM will need?
$1,000,000 *per occurrence or claims made*
Pharmacist must maintain malpractice insurance of how much?
$1,000,000 per occurrence or claims made (same as MTM)
Pharmacy must maintain an inventory worth how much?
$5000 of non-proprietary (prescription) drugs and devices at cost
What additional wording must be on the label of dietary supplements besides the structure/function claims?
- "this product has not been evaluated by the FDA" - "this product is not intended to diagnose, treat, cure, or prevent any disease"
What must a transfeREE pharmacist record on the face of a prescription they receive?
- "transfer" on the face of the script - date of issue of the original prescription - original number of authorized refills - original date of dispensing - number of valid refills remaining and the dates and locations of the previous refills - pharmacy name, address, DEA number, and prescription number from which the prescription information was transferred - name of pharmacist who transferred the prescription - pharmacy name, address, DEA, and prescription number from which the prescription information was originally filled
What are the requirements for intern hours for pharmacy student?
- 1500 hours, earning no more than 50 hours max credit in any week - 500 of the 1500 hours must be served in a pharmacy and the remainder may be earned in an internship program sponsored by the pharmacy college
First pregnancy test for iPLEDGE program can be done where? Where must the 2nd be done?
- 1st screening test can be in prescribers office - 2nd test must be in CLIA-certified laboratory according to the package insert
What are the specific areas and credits required out of the 30 CE credit hours?
- 2/30 in patient safety - 2/30 in administration of injectables, biologicals, immunizations (if have authority to administer injectables, biologicals, or immunizations) - 2/30 credits required in child abuse recognition and reporting - 2/30 credits in pain management, identification of addiction, or dispensing opioids
What does the Comprehensive Addiction and Recovery Act allow? What is a provision with this?
- Allows a pharmacist to partially fill CII for patients who are not terminally ill or residents of LTCF as long as the practice is not prohibited by state law IF partial is requested by patient or prescriber - any remaining portion must be filled within 30 days that the prescription was issued
What are the duties of a pharmacy intern?
- CANNOT be in a pharmacy if pharmacist is not on duty - may perform procedures which require professional skill and training (like compounding) when working under direct, immediate, and personal supervision of a pharmacist - may accept telephoned prescriptions from physician offices
CRNPs can prescribe CS under what restrictions?
- CII drugs for up to 30 DS - CIII-CV substances for up to 90 days
What are the rules on CS that a PA can prescribe?
- CII for initial therapy, up to 72 hour dose (if notify supervising physician ASAP, no longer than 24 hours from issuance of the prescription, and must state on face of script that it is for initial therapy) - CII for 30 day supply if it was approved by the supervising physician for ongoing therapy as long as it clearly states on its face that it is for ongoing therapy - CIII-CV substances permissible and up to 5 refills within a 6 month period to the extent authorized in the written agreement
What are the restrictions on prescribing of CS by midwife?
- CII substances are limited to 72 hour supply - CIII-CIV limited to 30 DS - CS only prescribed for woman's acute pain
CS prescriptions need what additional information on the prescription on file?
- DEA number of the prescriber - manual signature of the prescriber (unless it is an electronic script)
Pharmacist dispensing partial fill of CII needs to record what?
- date of partial filling - quantity dispensed - remaining quantity authorized to be dispensed - identification of the dispensing pharmacist
What is the two letter coding system for therapeutic equivalence?
- First letter is A or B; A indicates therapeutic equivalence or bioequivalence, B means either documented bioequivalence problem or potential for a problem - second letter describes the dosage form or nature of the product
Isosorbide dinitrate SL or chewable forms are exempt from PPPA in what amount?
10 mg or less
What are schedule B poisons?
- HCl acid - nitric acid - sulfuric acid - acetic acid - potassium and sodium hydroxide - chloroform - ether - formaldehyde - etc.
So what are the 3-2-2 filing method options? What does PA law say about these?
- II, III-V, non-controls (3 files) - II, III-V and non-controls (2 files) - II and III-V, and non-controls (2 files) *PA law says can only use first 2 methods* (CII scripts need to be separate)
Emergency dispensing of Schedule II drugs is allowed when? (3)
- Immediate administration of schedule II substance is necessary - No alternative treatment is available (would a schedule III work?) - It is not reasonably possible for the prescriber to present a written prescription prior to dispensing
Schedule V quantity limitations on difenoxin/atropine sulfate?
- NMT 0.5 mg of difenoxin and NLT 25 micrograms of atropine sulfate per dose
Schedule III quantity limitations on codeine?
- NMT 1.8 grams per 100 mL - NMT 90 mg per dosage unit
Schedule III quantity limitations on dihydrocodeine?
- NMT 1.8 grams per 100 mL - NMT 90 mg per dosage unit
Schedule V quantity limitations on dihydrocodeine?
- NMT 100 mg per 100 mL
Schedule V quantity limitations on ethylmorphine?
- NMT 100 mg per 100 mL
Schedule V quantity limitations on opium?
- NMT 100 mg per 100 mL
Schedule V quantity limitations on diphenoxylate/atropine sulfate?
- NMT 2.5 mg of diphenoxylate and NLT 25 micrograms of atropine sulfate per dose
Schedule V quantity limitations on codeine?
- NMT 200 mg per 100 mL
Schedule III quantity limitations on ethylmorphine?
- NMT 300 mg per 100 mL - NMT 15 mg per dosage unit
Schedule III quantity limitations on morphine?
- NMT 50 mg per 100 mL
Schedule III quantity limitations on opium?
- NMT 500 mg per 100 mL - NMT 25 mg per dosage unit
SLCP logbook must also include what?
- Notice stating "WARNING: Section 1001 of Title 18, USC states that woever with respect to the logbook knowingly and willingly falsifies, conceals, or covers up by any trick, scheme or device a material fact, or makes any materially false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined not more than $250,000 if an individual or $500,000 if an organization, imprisoned not more than 5 years, or both
Pharmacy permit should contain what information?
- name and address of pharmacy (can only display name under which it is registered) - name of current owner - name of current pharmacist manager
What are some examples of AMS?
- Parata Max - Pharmacy Automation systems - Pyxis - Omnicell - Script Pro
If a DEA CS registrant is regularly required to dispose of controlled substances (like a hospital), what can be issued? What is the condition?
- Special Agent in Charge can issue authorization for registrant to dispose of the substances without prior approval of the DEA in each instance - condition is that the registrant keep records of such disposals and file periodic reports with the special agent in charge summarizing the disposals
Pharmacists may inquire if a physician is qualified to write for buprenorphine by doing what?
- call 1-866-BUP-CSAT - email [email protected] - check SAMHSA web site
Drug Facts Panel must contain what?
- active ingredients - purpose - uses or indications - warnings (including if external, vaginal or rectal use, contraindications, situations when to ask doctor before using/list of applicable conditions, when to talk to doctor or pharmacist/drug-drug or food-drug interactions, side effects, signs of toxicity, pregnancy/breastfeeding warning, keep out of children and accidental overdose warning) - directions - other info as required by labeling, regulation, or monograph - inactive ingredients - questions? (optional) followed by telephone number
Candidate for authority to administer injectables, biologicals, or immunizations needs to meet what requirements?
- active license to practice pharmacy in PA - completed 10 hours of instruction and experiential training - basic CPR certification
How should the numbers in DEA number add up?
- add 2nd, 4th, 6th digits and double that about - then to that amount add first, third and 5th digits - last digit of total should correspond with the last digit in the DEA number
Pharmacist may only make what changes to CIII-CV prescription?
- add the patient's address or change patient's address upon verification - change or add dosage form, drug strength, drug quantity, or directions for use ONLY after consultation with and agreement of prescribing practitioner
Drug therapy management in an institution includes what processes?
- adjusting dose regimen - adjusting dose strength, frequency of administration, or route - ordering lab tests and ordering and performing other diagnostic tests necessary in the management of drug therapy consistent with the testing standards of the institution
If a device is permanently implantable or life-sustaining, it is required that the manufacturer do what two things?
- adopt a method of device tracking to ensure that patients can be notified if necessary (and similar restrictions are placed on distributors) - conduct post marketing surveillance
Glaucoma certified optometrists may prescribe what?
- adrenergic receptor agonists - beta adrenergic receptor blockers - cholinergic receptor agonists - prostaglandin analogs - topical carbonic anhydrase inhibitors - in addition to all the meds that can be prescribed by therapeutically certified optometrists
Definition of treatment for HIPAA purposes?
- all activities associated with filling prescriptions or medication orders including disclosures concerning the drug therapy with prescribers or other health care professionals, DUR activities, and dispensing the medication to the patient
Now, breaches of PHI are presumed to be what and need to be reported how?
- all breaches assumed to cause harm - need to report unless there is low probability that PHI was compromised
What are the provisions for partial filling of CIII-CV scripts? (3)
- all partial fills are recorded in same manner as a refill - total quantity prescribed in all partial fillings doesn't exceed the total quantity prescribed - no dispensing occurs beyond 6 months after prescription is issued
What classes of medications may be prescribed by CRNP?
- antihistamines - anti-infective agents - antineoplastic agents, unclassified therapeutic agents, devices and pharmaceutical aids - autonomic drugs - blood formation, coagulation, and anticoag drugs and thrombolytic and antithrombolytic agents - CV drugs - CNS agents - contraceptives including foams and devices - diagnostic agents - disinfectants for agents used on objects other than skin - electrolytic, caloric, and water balance - enzymes - antitussive, expectorants, and mucolytic agents - GI drugs - local anesthetics - eye, ear, nose, throat preparations - serums, toxoids, and vaccines - skiin and mucous membrane agents - smooth muscle relaxants - vitamins - hormones and synthetic substitutes
Therapeutically certified optometrists may not prescribe what?
- any parenteral drug - beta blockers - drugs for systemic conditions except as an adjunctive therapy and shall be limited to anterior eye structures - drugs for glaucoma
What are schedule A poisons?
- arsenic - cyanides - mercury compounds - thalium - etc.
How does the FD&C Act define the term drug?
- articles recognized in the official USP, Homeopathic Pharmacopoeia of the US, or the NF, or any supplement to them - articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, in man or other animals - articles (other than food) intended to affect the structure or any function of the body of man or other animals - articles intended for use as a component of any article specified in the above clauses, but does not include devices or their components, parts, or accessories
What are some common OTC drugs that are *subject* to the requirements of the PPPA (with amounts)?
- aspirin in any dosage form/amount - iron containing drugs with elemental iron of 250 mg or more - Iron containing dietary supplements with elemental iron of 250 mg/package - acetaminophen more than 1 gram in a single package - diphenhydramine more than 66 mg of diphenhydramine base in a single package - ibuprofen in oral dosage form with 1 gram or more in a single package
Written protocol for MTM must be available where?
- at the practices site of any licensed physician or pharmacist who is in party to the agreement - at the institution where a written agreement or protocols is in place - to any patient whose drug therapy management is affected by the agreement - upon request to representatives of the Bureau and the Department of Health and the written protocol shall be filed with the Bureau
Physician should do what as part of drug therapy management?
- authorize pharmacist - supervise - notify patients of role of pharmacist whose drug therapy management may be affected by the pharmacist through drug therapy management
Besides distinguishing prescription from OTC, Durham Humphrey amendment also did what?
- authorized refills on scripts - authorized oral (telephoned) prescriptions - deemed prescription label to meet adequate directions for use requirement
Course on injectables/immunizations must include information on what?
- basic immunology and human immune response - mechanics of immunity, adverse effects, dose and administration schedule of available vaccines - response to an emergency situation as result of the administration - administration of subQ, intradermal, and IM injections - disease epidemiology - standards for immunization practices - vaccine preventable diseases - recommended immunization schedules - vaccine storage and management - biohazard waste disposal and sterile techniques - informed consent - authority and recordkeeping requirements
What kinds of materials can compounds be compounded with?
- bulk drugs manufactured by an entity registered with the FDA - ingredients that comply with USP monograph standards - component of an FDA approved human drug product
Pharmacist transferring a prescription out does what?
- cancels the original prescription in his/her records - indicates on the prescription records to whom the prescription was tranferred, including name of pharmacy - indicates date of transfer and his/her name or initials as the transferring pharmacist
What are the duties of a pharmacy technician, and what may they not do?
- cannot accept or transcibe an oral or telephoned prescription - may not enter or be in pharmacy if pharmacist is not on duty - cannot perform any act within the practice of pharmacy that involves discretion or professional judgement - may assist in reconstituting parenterals, etc. after which pharmacist initials the product to accept full responsibility - may not perform a duty until trained in that duty and the duty is specified in written protocol
What are the restrictions on tax free alcohol?
- cannot be given to patients as a beverage or used as food
What meds are exempt from CRC requirements?
- certain effervescent powders containing acetaminophen or aspirin - and unflavored acetaminophen or aspirin powders
Why would CSOS certificate be revoked?
- certificate holder is no longer authorized to sign schedule II orders for the registrant - if the information on which the certificate is based changes - if digital certificate used to sign electronic orders has been compromised, stolen, or lost
Whats the trick to differentiating between classes of medical devices?
- class I = no measurement that needs to be tested, very simple - class II = all require some sort of measurement (like calibration or sterility) - class III - needed for life support, life sustaining, or has high risk of illness or injury associated with it
What are the 9 members of the state board of pharmacy?
- commissioner of professional and occupational affairs - director of bureau of consumer protection or designee - 2 members of the public - 5 pharmacists (all with at least 5 years prior experience who are not teachers in a pharmacy school; 2 independent pharmacists, 2 chain pharmacists, 1 acute care institutional pharmacist)
If prescription is entered into a computer and placed on hold, what conditions must be met?
- complete prescription information must be entered into the computer - information must appear in patient's profile - must be positive identification in the computer system or on hard copy of the pharmacist who is responsible for entry of the prescription information into the system
What other issues were clarified under FDAMA in regards to compounding?
- compounding pharmacies don't have to comply with GMPs - don't have to seek FDA approval of products the compound - have to put physician specified directions on the label to comply with adequate directions for use requirement
Multiple CII prescriptions may only be issued if the practitioner concludes what? And if practitioner does what?
- concludes that providing the patient with multiple prescriptions in this manner does not create undue risk of diversion or abuse - and if practitioner complies with all other requirements under the Act and these regulations as well as any additional requirements under state law
PA board of pharmacy may revoke, suspend the certificate of registration for non-resident pharmacy in what situations?
- conduct which causes serious bodily injury or psychological injury to a resident of the commonwealth provided the board has referred the matter to the regulatory or licensing agency in the state in which the non-resident pharmacy is located - upon proof satisfactory to the board that the nonresident pharmacy's permit to conduct a pharmacy was suspended or revoked or the nonresident pharmacy was otherwise disciplined by the proper licensing authority of another state
If prescriber is contemplating prescribing an opioid to a minor, what guidelines must be followed?
- consent form signed by parent or authorized adult - advise on the risks and dangers of opioids - cannot prescribe more than 7 days of an opioid to a minor (or only for 72 hours if the individual who signs the consent is an authorized adult instead of a parent)
What is the 3 pronged approach of the S.T.E.P.S. program?
- controlling access to the drug - educating prescribers, pharmacists, and patients - monitoring compliance
What are the required reference materials in a pharmacy?
- current copies of pharmacy act - current copies of title 49, chapter 27 - Federal and PA statues and regulations pertaining to practice of pharmacy - and adequate reference library
What do CS prescriptions need to contain?
- date and signature, both completed on day they were issued - full name and address of patient (if animal use name and address of owner and species of animal) - drug name, strength, dosage form, quantity prescribed, directions for use - name, address, DEA number of prescriber - manual signature of the physician, no signature stamps
Record of destruction or disposal of cancer drugs that are not accepted for donation may include what?
- date of destruction - name, strength, quantity of cancer drug destroyed - name of person or firm that destroyed the drug - source of drugs destroyed
NOPP must convey what information to the patient?
- description and at least one example of how pharmacy will use patient's PHI - statement of the types of uses and disclosures that require prior authorization from the patient - statement advising the patient that the pharmacy is required to maintain the confidentiality of PHI - statement of the patient's rights under HIPAA, including the right to request restrictions on the disclosure of PHI, the right to access PHI, the right to request amendments to PHI maintained by the pharmacy, and right to obtain an accounting of certain disclosures of PHI made by the pharmacy - identity of the pharmacy's privacy officer
What are the ways that a registered pharmacy can dispose of CS?
- destroy the CS using on site method of destruction (only available if pharmacy is DEA registered as a collector) - deliver to a reverse distributor's registered location by common or contract carrier pick up, or by reverse distributor pick up at the registrant's location - for return or recall deliver CS by common or contract carrier pick up to registered person from which it was obtained, manufacturer, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf - request assistance from the Special Agent in Charge of the Administration in the area where the practitioner is located
How are patients eligible to be a part of the cancer drug repository program?
- diagnosed with cancer - doesn't possess or has limited prescription drug coverage related to the treatment of the patient's cancer so that the coverage limits prevent the patient from obtaining cancer drugs - patient doesn't meet the eligibility requirements for state medical assistance program that provides prescription drug coverage related to the treatment of cancer - PA resident meets income limits (prior year's family income not to exceed 350% of the prior year's Federal Poverty Income Guidelines) for the appropriate family size (income limits posted on the Board's web site)
For non-resident pharmacy, what are the administrative requirements?
- disclose on all initial and renewal applications the location, names, and titles of all principle corporate officers and the pharmacist in charge - report to the board within 30 days after any change of location or pharmacist in charge - submit a statement that the non-resident pharmacy complies with all lawful directions and requests for information from the agency of the state in which it is licensed, as well as complies with all requests for information made by the state board - maintain at all times a valid unexpired license, permit, or registration to conduct the pharmacy in state which it is located - submit a copy of the pharmacy's most recent inspection report - report to the board within 30 days of final disposition of any disciplinary action taken by the agency in its home state
Accounting of disclosures does not include what?
- disclosures made to carry out TPO - disclosures made pursuant to an authorization - certain law enforcement purposes - few other limited exceptions
What are the exceptions permitting methadone use outside a clinic?
- dispensing by a physician over 3 day period while in the process of enrolling a patient in a clinic; would need to be in physician office, no prescription - administering to a patient while hospitalized for a condition unrelated to the addiction - for intractable pain (like terminal cancer patient)
What are the stipulations to an individual practitioner prescribing CS under a hospital's DEA?
- dispensing/administering/prescribing is done in the usual course of professional practice - practitioner is authorized to do so by the jurisdiction in which he is practicing - hospital/institution by which practitioner is employed has verified that the practitioner is permitted to dispense, administer, or prescribe drugs within the jurisdiction - individual practitioner is acting only within the scope of his employment in the hospital/institution - hospital authorizes the intern/resident/foreign trained physician to prescribe under the hospital registration with individual code - DEA registration code will consist of numbers, letters, or combination and will be suffix to the institutions DEA number, preceded by a hyphen - list of codes and respective practitioners is made available to other registrants and law enforcement agencies
Cancer drug repository informed consent form must contain what information?
- drug being dispensed has been donated and may have been previously dispensed - drug was unused even though it was previously dispensed - drug was donated to the approved, participating pharmacy in the drug's original unopened, sealed, and tamer evident packaging to be redistributed - visual inspection has been conducted by the pharmacist in a manner as to be able to reasonably determine that the drug has not expired, has not been adulterated or misbranded - CANNOT guarantee the safety of the drug being dispensed or administered, but the pharmacist as determined that the drug appears to be safe to dispense or administer based on accuracy of the donor form and the visual inspection required
When are drugs ineligible for cancer drug repository program?
- drug has expiration date that is earlier than 6 months after the date the drug will be restocked - drug shows evidence of having been adulterated for misbranded - drug is a controlled substance - drug is subject to restricted distribution by the FDA - drug requires refrigeration, freezing, or special temperature requirements beyond controlled room temperature - drug has been previously compounded
Prescriber education on ER/LA opioid analgesics will include what?
- drug information - information on assessing patients for treatment with these drugs - initiating therapy, modifying dosing, discontinuing use of ER/LA opioids - managing safe use of these drugs - learning to recognize evidence and potential for opioid misuse, abuse, and addiction
What is the required labeling for unit dose packaging?
- drug name - drug strength - lot number - expiration date - name and place of business of manufacturer, packer, or distributor
What are the circumstances where the FDA has determined a MeGuide must be required?
- drug product is one for which patient labeling could help prevent serious adverse effects - drug product is one that has serious risks of which patients should be made aware because information concerning the risks could affect patients decisions to use the product - the drug product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness
PDMA bans trade, sale, or purchase of what?
- drug samples - prescription drugs that have been purchased by a hospital, health care entity, or charitable organization
What is the REMS for ER/LA opioid analgesics? What does it involve?
- education program for prescribers (physicians, nurse practitioners, physician assistants) - sponsors of ER/LA opioid analgesics will make available education programs to all DEA registered prescribers through educational grants to accredited CE providers to offer training to prescribers at no or nominal cost - also includes patient counseling document to be given to patients, helping prescribers to properly counsel patients on their responsibilities for using these medications safely
What defines an adequate reference library?
- enables the pharmacy to prepare and dispense prescriptions properly according to pharmacy's scope of practice - is appropriate to the type of practice (i.e. current material regarding technical, clinical, and professional aspects of practice) - enables compounding in safe and effective manner - lists drug interactions and possible adverse effects - lists the therapeutic equivalents or medications - lists therapeutic usage and dosages of medications - provides guidelines for counseling - maintains latest editions including supplements for those references maintained by the pharmacy
What are the requirements for auxillary procedures to document refills in event of system downtime?
- ensure that refills are authorized by the original prescription order - max number of refills has not been exceeded - all the appropriate data is retained for on-line data entry as soon as the computer system is available
What are the anabolic steroids? (8)
- ethylestrenol (Maxibolin) - stanozolol (Winstrol) - Testosterone patch (Androderm, Testoderm) - methandrostenolone (Dianabol) - nandrolone decanoate (Deca Durabolin) - fluoxymesterone (Halotestin) - oxandrolone (Anavar) - oxymetholone (Anadrol)
What are the current FDA rule on unit dose packaging expiration date? Example?
- expiration date is not to exceed 6 months and the 6 month period cannot exceed 25% of the remaining time between the date of repackaging and the expiration date on the unopened original manufacturers container - Ex: in order to repack on 1/1/16 with a 6 month expiration date, the manufacturers container must have an expiration date of 1/1/18 or later
If there is a suspicion of addiction/diversion by another professional and you fail to report it (or fail to report in reasonable time frame), what could the penalties be?
- fine not to exceed $1,000
What is the process for filling an emergency supply prescription?
- first attempt to obtain authorization from the authorized prescriber, but is unable to contact - pharmacist must provide only 1 refill and the quantity must conform to the directions for use; limited to 72 hour supply - pharmacist must enter on back of prescription or on another appropriately uniformly maintained and readily retrievable record, the date and quantity of the refill and enter signature - within 72 hours the pharmacist must notify the prescriber that an emergency refill was dispensed
Compounded drug can only be prepared pursuant to what?
- for an individual patient based on a valid prescription - or for a limited quantity if prepared in anticipation of a prescription based on a past compounding history
If Med Guide is required for a drug, what must manufacturer of the drug do?
- get FDA approval of the Med Guide before it is distributed - ensure that the med guides are provided in sufficient numbers or provide the means to produce Med guides in sufficient numbers to distributors, packers, and authorized dispensers
What drug categories cannot be prescribed by CRNP?
- gold compounds - heavy metal antagonists - radioactive agents - oxytocics
Any hospital, healthcare facility, peer, or colleague has cause to report to board (mandatory reporting) if there is evidence that a professional....?
- has active addictive disease for which they are not receiving treatment - is diverting a controlled substance - is mentally or physically incompetent to carry out the duties of his or her license or certificate
In order for LTCF to receive medications from outside pharmacy of patient's choice, must do what?
- have procedures for receipt of medications from outside pharmacies including those for ensuring accuracy and accountability - pharmacist must maintain monthly medication profile from the resident's selected pharmacy - policy shall be established regarding procuring medications in urgent situations (like 7 day supply of medication from LTCFs pharmacy may be used if residents selected pharmacy is not able to comply with provisions)
For medicare to participate in hospital environment, what are the requirements for the pharmacy?
- have to have pharmacy directed by registered pharmacist or drug storage area under competent supervision - medical staff is required to develop policies and procedures to minimize drug errors - have to have adequate number of personnel to ensure quality pharmaceutical services - have to ensure current and accurate records are kept of the receipt and disposition of all scheduled drugs
What are the requirements under the PPL REMS program?
- healthcare providers who prescribe need to be specially certified - each patient must have signed Patient Acknowledgment form for documentation - pharmacists will only dispense Lotronex to patients with documentation of safe use conditions
What are some examples of acceptable structure/function claims for dietary supplements?
- helps improve mood (but can't say reduces depression) - maintains a healthy circulatory system (but can't say prevents cardiovascular disease) - maintains cholesterol in a healthy range (but not lowers cholesterol) - supports the immune system (but not helps prevent colds and flu)
Policies for receiving oral orders in LTCF shall include what?
- identification of all medications and treatments which may not be prescribed and dispensed pursuant to an oral order - requirement that all orders by stated clearly, repeated by the issuing practitioner, and be read back in their entirety by personnel authorized to take the order - identification of all personnel authorized to take and transcribe oral orders - policy on fax transmissions
Need to provide what information after giving injectable pursuant to protocol to physician/PCP?
- identity of patient - identity of the medication, biological, or immunization - site of administration - dose administered - date of administration
When notifying prescriber/PCP of injectable administration pursuant to order, need to give what information?
- identity of the patinet - identity of medication, biological, or immunization administered - route of administration (order only) - site of administration - dose administered - date of administration
What information must an order for an injectable contain?
- identity of the prescriber issuing - identity of the patient to receive the injection - identity of the medication, immunization or vaccine, and dose - date of the original order and date or schedule of any subsequent administration
What must OTC drug labels contain?
- identity of the product (established name) - pharmacologic property - name and address of the manufacturer, packer, or distributor - net contents of the package - cautions or warnings needed to protect the consumer - adequate directions for use - drug facts panel
All normal labeling requirements for CS are waived in the institutional setting if what?
- if CII dispensed is NMT 7 day supply - if CIII-CV is dispensed in a 34 day supply or 100 unit doses, whichever is less - drug is not in possession of ultimate user prior to administration and other appropriate safeguards are instituted
Pharmacist does not need to review original Rx before dispensing CII med from faxed prescription if what?
- if CII is compounded for direct administration to a patient by parenteral, IV, IM, SC or intra-spinal infusion - CII narcotic is for a hospice patient - CII is for patient in an LTCF
In what situations does an already approved drug become a "new drug" and have to go through NDA approval process?
- if drug contains a new substance (either active, carrier, excipient, or coating, etc.) - when there is a new combination of approved drugs - when the proportion of ingredients in combination is changed - when the dosage, method, duration of administration, or application is changed - when new use for a drug is claimed even though the drug isn't new (new indication)
In what situations will board consider non-traditional internship?
- if it is submitted to the Board 90 days in advance - the intern still needs to earn 500 hours in a pharmacy
What are the circumstances that allow pharmacist to substitute biological product for prescribed biological?
- if product is interchangeable as determined by FDA - if prescriber does not verbally or in writing prohibit substitution - if the person presenting the Rx receives notification of such substitution - within 72 hours of dispensing the pharmacist notifies the prescriber of name of product and manufacturer using specific means
What are the two contexts that Phase IV clinical studies would be completed?
- if the FDA had performed and expedited approval of the drug and wanted manufacturer to complete more clinical studies - if the manufacturer wanted the FDA to approve an additional indication for a drug and was performing clinical studies to support that request
When will board not grant credit for intern hours?
- if the hours were worked before obtaining internship registration without showing good cause - if the hours were served in a pharmacy where the supervising pharmacist was not registered as a preceptor - if the hours were earned while performing activities not related to the practice of pharmacy
Board will only grant internship to pharmacy college internship program if what?
- if the internship program is full-time - if there is no concurrent academic caseload - if the individual achieves a passing grade in the program
What other situations would require a pharmacy to comply with FDA registration, inspections, and GMPs as a "manufacturer"?
- if the pharmacy in hospital A repackages drug products for its own use as well as for that in hospitals B and C - if the pharmacy chain repackages and relabels quantities of drug products from the manufacturers original commercial containers for shipment to the individual franchises of the chain - If similar repackaging and re-labeling are conducted by individual pharmacies as members of an informal buying group
If pharmacy closing occurs, what must be done?
- immediately return Permit to the Board of Pharmacy - notify the Board of the disposition of the files and prescription drugs (unless 30 days beyond closing, then need Board permission to sell, transfer, or dispose of files and drugs) - remove pharmacy signs/symbols from the interior and exterior
Any subsequent unlawful acts committed after first may result in what penalties?
- imprisonment of not more than 3 years or fine not more than $15000 or both
How is protected health information (PHI) defined under HIPAA?
- information created or received by a covered entity - relates to an individuals past, present, or future physical or mental health condition - identifies the individual or creates a reasonable basis to believe that the information can be used to identify the individual
Manufacturer is required to submit what as part of IND?
- information on the name of the drug, composition, methods of manufacturing, quality control, information from pre-clinical (animal) testing, pharmacological, pharmacokinetic, and toxicology studies - an outline of the proposed clinical studies as well as the experience of the clinical investigators
Central processing center is exempt from what requirements normally in place for a regular pharmacy?
- inventory requirement of $5000 worth of non proprietary drugs or devices - minimum size requirements - requirement for sink used only for pharmaceutical purposes
Drug is considered adulterated if what (even if the drug itself is pure it may be considered adulterated if what)? (7)
- it is prepared, packaged, or held under unsanitary conditions where it may have been contaminated with filth or rendered injurious to health - it is manufactured in a way that does not conform to GMPs established by FDA - the container is composed of poisonous to deleterious substance that may leech into the contents - contains or is an unsafe color additive - if it purports to be or is a drug that is recognized in an official compendium and its strength quality, or purity varies from official compendial standards (unless variations are plainly stated on the label) - drug is not listed in official compendium, yet the strength, quantity, or purity differs from that which it purports to possess - if it is a drug and any substance has been added to it to reduce its quality or strength, or any substance has been substituted in whole or part
Investigational drugs can be approved for patients in the general population provided what?
- it is pursuant to treatment protocol that has been submitted to the FDA - the drug is used to treat a serious or immediately life threatening disease - there is no comparable or satisfactory alternative drug or other therapy available - the drug is an approved investigational new drug being used in a controlled clinical trial, or all clinical trials have been completed and the sponsor of the clinical trial is actively pursuing market approval
REVIEW USP <800>
- known appropriate disposal of hazardous drugs - training requirements - environmental controls for the proper storage, handling and disposal of hazardous materials - methods for compounding, dispensing, and administration of hazardous materials
What labeling requirements are there for Ipecac syrup?
- label bears a statement saying "For emergency use to cause vomiting in poisoning. Before use call physician, the Poison Control Center, or hospital emergency room immediately for advice." - warning stating "keep out of reach of children, don't use in unconscious persons. Ordinarily this drug should not be used if strychnine, corrosives like alkalies (lye) and strong acids, or petroleum distillates such as kerosene, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested."
Drug or device is considered misbranded if what? (8)
- label or labeling is false or misleading in any particular - drug is listed in official compendium unless labeled and packed according to compendial standards - package or the drug is misleading in the way it is filled or formed or is imitative of another drug or offered for sale under the name of another drug - drug is subject to deterioration, unless the label bears appropriate precautionary statements - drug/device is health-endagering if used in the manner suggested by the labeling - *drug is subject to the PPPA and is not packaged accordingly* - drugs dispensed via prescription if at any time prior to dispensing the label of the drug failed to state at a minimum Rx only or says Rx only and it is not - if a pharmacist sells a drug without a prescription or refills a prescription without authorization
Prescription blank for PA needs to contain what?
- license number and name of PA printed at heading - license number and name of supervising physician - signature of PA, which should be followed by PA-C or similar designation - when appropriate PA's DEA number
Prescription blank for midwife must contain what?
- license number, name and contact information, phone number printed at heading of blank and C.N.M. - signature of the nurse-midwife must be followed by the initials C.N.M. or similar designation to identify the signer as nurse midwife
What are the components of the TAP REMS program?
- limited availability to specialty distributor pharmacies - requires the certification of prescribers and dispensers and enrollment of patient - educational requirements apply to prescribers, dispensers, and patients
What are the exceptions to the 72 hour rule for partial filling of CII scripts? What does pharmacist need to do in these instances?
- long term care facility may dispense partial quantities of schedule II up to 60 days - pharmacist may dispense partial of CII up to 60 days to patients with a medical diagnosis documenting a terminal illness - NOTE if patient is terminally ill or LTCF patient on prescription
What are the 3 days prescription drugs can be switched to OTC drugs?
- manufacturer can request the switch by submitting a supplemental application to its original NDA - manufacturer may petition the FDA - FDA may add or amend an existing OTC monograph
Separate controlled substance registrations are required for what activities normally?
- manufacturing - distributing - reverse distributing - dispensing/instructing - research - importing - exporting - narcotic treatment program - chemical analyses
What are reasons for the Attorney general to revoke CS registration?
- materially falsified the application - has been convicted of a felony relative to controlled substances - has had a state license or registration suspended, revoked, or denied
What are the only medications approved for treatment of narcotic addiction in treatment programs?
- methadone - levo alpha acetyl methadol (LAAM) - buprenorphine sublingual - buprenorphine-naloxone
QA program for AMS requires what?
- monitoring of AMS - establishes mechanisms and procedures to test the accuracy of the automated medication system at least every 6 months and whenever any upgrade or change is made to the system - requires the pharmacy to maintain all documentation relating to the written program for QA for at least 2 years and upon request provide information to the Board regarding quality assurance program
In order to be pharmacist, must meet what criteria?
- more than 21 years of age - US citizen - good moral and professional character - not unfit due to alcohol, CS, or physical or mental disability - BS or advanced degree in pharmacy - internship completed or equivalent program, or demonstrated equivalent experience - passed board examinations - not convicted of a felony related to CS unless 10 years have lapsed since, demonstrated personal rehabilitation and not expected to create a substanctial risk of harm to the health and safety or patients or public - meets CE requirements
What are the requirements for mailing a controlled substance?
- must be placed in plain outer mailing container or securely overwrapped in plain paper - inner container must be labeled to show prescription number and name and address of the pharmacy, practitioner, or other person dispensing the prescription - outer mailing wrapper or container is free of markings that indicate the nature of the content
Outsourcing facilities must follow what rules?
- must comply with CGMP - will be inspected by FDA according to risk-based schedule - must meet certain other conditions like reporting adverse events and providing FDA with certain information about the products they compound
What is the process for a physician to obtain an investigational drug for a patient not involved in a clinical study?
- must ensure that manufacturer is willing to provide the drug - if manufacturer agress then physician needs to submit IND to the FDA - FDA needs to receive individual IND before shipment or treatment with drug may begin - number assigned to application - treating physician should supply IND number to drug supplier so supplier may ship the drug to the treating physician - FDA will either allow treatment to proceed or not allow it and put application on hold - treatment may proceed 30 days after FDA receives the IND submission and has not otherwise put the application on hold, or upon earlier notification of the physician by FDA
If a CS is filled at a central fill pharmacy prescription label must show what? Who sets these requirements?
- must have retail pharmacy name and address, unique identifier (like DEA registration) and indication that it was filled at a central fill pharmacy - DEA pharmacists manual makes these requirements
What are the DEA requirements for Central fill pharmacies taking part in central filling?
- must keep copy of the prescription if sent by fax or electronic record of info including name, address, DEA number of transmitting pharmacy - record of the date of receipt of the transmitted prescription - record name of pharmacist filling prescription and date of filling - record of date delivered to retail pharmacy and method of delivery
In order for a pharmacy to be approved for intern training, they must meet what requirements?
- must not be in violation of federal, state, or municipal statutes even if not related to pharmacy practice - shall be managed so that the emphasis is on activities connected with the distribution of articles and services pertaining to medical care - pharmacy is kept sanitary, orderly, and clean condition, and the prescription department shall meet applicable statutory and regulatory requirements - pharmacy shall compound and dispense a sufficient number of prescriptions to provide ample opportunity for internship experience - pharmacy shall employ a licensed pharmacist who is registered as a pharmacy preceptor
New permit is required and filed for within 30 days of changes to what?
- name - ownership - controlling interest
What is some info that is on the DEA form 106?
- name and address of firm - DEA registration number - date of theft or loss - if police were notified or not - type of theft or loss - items taking or lost including estimated value - any identifying symbols or cost codes on the containers - list of missing items - name and title of person completing the report
What must a CS prescription label contain in PA?
- name and address of pharmacy - phone number and DEA number of pharmacy - serial # and date of initial dispensing - name of patient and prescribing practitioner - directions for use and any cautionary statements including "Caution: Federal Law prohibits transfer of this drug to any person other than the patient for whom it is prescribed." - trade or brad name of the drug, strength, dosage form, quantity dispensed, manufacturers name or suitable abbreviation of the manufacturer's name
Bulk prescription container labels must contain what?
- name and address of the manufacturer, packer, or distributor - established name of the drug product - ingredient information, including the quantity and proportion of each active ingredient - if for other than oral use, the names of all inactive ingredients - quantity of the container in terms of weight or measure (like 100 mg) - net quantity or the container (like 1000 tablets) - statement of the recommended or usual dosage, or reference to the package insert - legend "Caution, federal law prohibits dispensing without a prescription" or "Rx only" - route of administration if it is not oral - identifying lot or control number - statement directed to the pharmacist specifying the type of container to be used in dispensing the drug (Dispense in tight, light-resistant container) - expiration date, unless exempted - labeling on or within the package must contain adequate information for use
Prescriptions kept on file in a pharmacy need to include what?
- name and address of the patient - name and address or other identifier of the prescriber - date the prescription was issued - name and quantity of the drug prescribed - directions for use; including cautions communicated to consumer - date the prescription was compounded and dispensed - name or initials of the dispensing pharmacist
What are some relevant factors the pharmacist may consider during counseling?
- name and description of medication - route of administration, dosage form, duration of therapy - special directions and precautions for preparation, administration, and use - common severe side effects or interactions and therapeutic contraindications, their avoidance, and actions required if the occur - techniques for self monitoring therapy - proper storage - prescription refill information - action to be taken in the event of a missed dose
What information needs to be recorded for every cancer drug received, dispensed, distributed, or disposed of in the Cancer drug repository program?
- name and strength - quantity of drug - expiration date - lot number - name of pharmacy that originally dispensed the cancer drug - name of donor - name of person to whom it was originally prescribed - name of person to whom it was dispensed - date it was dispensed - name of the prescribing practitioner who wrote the prescription for the cancer drug to be dispensed under the Cancer Drug Repository program - date the cancer drug was disposed of or destroyed - whether a handling fee was charged and the amount of the fee
Online retrieval of current refill history of CS prescription means retrieving what?
- name of CS - date of refill - qty dispensed - ID code or name or initials of the dispensing pharmacist for each refill - total number of refills dispensed to date for that prescription order
Pharmacy records what for any CIII-CV drugs that are being sent to reverse distributor?
- name of drug - strength - quantity - date of transfer
Label of pre-packed medication needs to contain what?
- name of drug and if generic then include manufacturer - Strenght, manufacturers control #, and expiration date if any
Pharmacies are required to enter what info in ABC-MAP? WHen does it have to be entered?
- name of prescriber - prescribers DEA number - date Rx was written - date Rx was filled - name, date of birth, gender, address of patient - NDC number of the drug dispensed, quantity, days supply - DEA and NPI numbers of the pharmacy - payment method the patient used enter within 1 business day of dispensing
Print out of refill information for a CS must include what for refill by refill audit trail?
- name of prescribing practitioner - name and address of patient - quantity dispensed on each refill - date of dispensing for each refill - name or ID code of dispensing pharmacist - number of the original prescription order
What needs to be recorded regarding each administration of an injectable?
- name, address, date of birth of a patient - date of administration and site of injection - name, dose, manufacturer, lot number and expiration date of the medication, biological, or immunization - name and address of patient's primary care health provider as identified by the patient - name or identifiable initials of the administering pharmacist - documentation of informed consent - any adverse reaction that was noted
What information needs to be submitted to the Board in order to become a Cancer Drug Repository Program?
- name, address, telephone number of pharmacy - identification and background of pharmacy's ownership - description of all pharmacy services provided and location and manner in which services are provided - certification by a pharmacist that the pharmacy meets the eligibility requirements for participation in the Center Drug Repository Program - name and telephone number of pharmacist who made the certification
A prescription label must contain what information?
- name, address, telephone number, and DEA number of pharmacy - name of patient and prescriber - full directions for use - serial number of the prescription and the date originally filled - trade or brand name of the drug, strength, dosage form, and quantity - if generic drug also need to include manufacturers name or suitable abbreviation
Pharmacist must make reasonable effort to obtain what information for the patient profile?
- name, address, telephone number, date of birth or age, gender - individual history if significant, including allergies and drug reactions, list of medications and relevant devices as provided by the caregiver or patient - pharmacist's comments relative to the patient's drug therapy (i.e. if a problem was discovered with therapy and how the problem was resolved)
Prescription blank for optometrists should contain what?
- name, address, telephone number, fax number, and license number of optometrist - name of patient - date prescription issued - name of drug, quantity, potency, expiration date, number of refills, directions for use any precautions
Prescription blanks for CRNP will contain what?
- name, title, certification number - when appropriate NPI number - space for entry of the DEA registration number, if applicable
Online retrieval of original prescription order information means being able to retrieve what?
- original prescription number - date of issuance of original prescription - full name and address of the patient - name, address, DEA of the practitioner - name, strength, dosage form, qty of the CS prescribed - total number of refills authorized by the prescriber
What are the specific requirements for a collaborative agreement?
- need to identify pharmacist and physician - require the regimens for management of drug therapy be initiated by physician - identify the types of decisions regarding the management of drug therapy that the pharmacist is authorized to make within scope of practice and types of management of drug therapy authorized - identify terms under which pharmacist is permitted to engage in drug therapy management without consent by collaborating physician - specify functions and tasks the pharmacist shall follow including method for documenting decisions made and plan for communication of feedback to the authorizing physician concerning specific decisions made - provide for execution of the agreement when the participating physician or pharmacist is temporarily unavailable - notify the patient of the collaborative agreement, and provide opportunity for the patient to refuse management of drug therapy by a pharmacist - signatures of both physician and pharmacist, date and allowance of the termination of the collaborative agreement at the request of either party at any time
If pharmacy is located in a retail establishment, but has different hours, what are the requirements?
- needs to be securely sealed off from the remainder of the retail establishment by an impenetrable floor to ceiling barrier - needs to be securely locked whenever a pharmacist is not present and on duty and shall be closed whenever a licensed pharmacist is not present and on duty - safes, electrical equipment, etc. of the retail establishment may not be located in, or approached through the pharmacy unless a pharmacist is on duty when individuals from the retail establishment need access - hours of pharmacy shall be posted at all points of public access - protocols for access to the pharmacy for bona fide emergencies when its closed shall include notification to the pharmacist manager
What are prescription medications that are exempt from PPPA with no quantity limits?
- nitroglycerin SL dosage forms - anhydrous cholestyramine powder form - any preparations in aerosol containers intended for inhalation therapy - pancrelipase preparations - oral contraceptives (cyclically administered in manufacturer's memory aid dispenser packages) - medroxyprogesterone acetate tablets - sacrosidase (sucrase) preparations in a solution of glycerol and water - hormone replacement therapy products that rely solely upon the activity of one or more progestogen or estrogen substances
What are the requirements for sale of syringes or needles?
- no age limit - no quantity limit - no recordkeeping requirement - but must be under direct, immediate, or personal supervision of the pharmacist
In an applicant for pharmacy permit is an association, what are the requirements?
- no director or officer has pled guilty or nolo contendere related to practice of pharmacy or moral turpitude - no directed or officer has had a pharmacy or pharmacists license revoked or renewal refused for cause
If pharmacy permit applicant is a corporation what requirements must be met?
- no director or officer or person having a beneficial interest of more than 10% of the stock has pled guilty or nolo contendere related to practice of pharmacy or moral turpitude - no director or officer or person having beneficial interest amount of more than 10% of the stock has had a pharmacy or pharmacists license revoked or renewal refused for cause
Isotretinoin REMS program strives to ensure what?
- no female patient starts isotretinoin if pregnant - no female patient on isotretinoin becomes pregnant
In order to meet adequate directions for use requirements what needs to be included?
- normal dose for each intended use and doses for individuals of different ages - frequency and duration of administration or application - administration or application in reference to meals, onset of symptoms, etc. - route of method of administration or application - any required preparation for use
What are the requirements to be a pharmacy preceptor?
- not convicted of criminal offense related to the practice of pharmacy - shall hold a license to practice pharmacy without restriction and shall be engaged in active practice of pharmacy - shall be working on a full-time basis in a pharmacy approved for intern training - may not direct the training of more than two pharmacy interns at one time (unless approved by board) - shall notify the board whenever a new intern is accepted for training by the pharmacy as well as the anticipated period of internship - shall be responsible to ensure that the intern receives proper training - shall certify to the beginning and completion of respective internships and may make recommendations to the board on the competency of the intern
Pharmacist who is receiving a transferred prescription needs to record what?
- note that it is a transferred prescription on the script - date of issuance of original script - date of original filling - original number of refills authorized - complete refill record from original prescription - number of valid refills remaining - location and file number of the original prescription - name of the pharmacy and pharmacist from whom the prescription was tranferred
If records are kept centrally, what needs to be sent to DEA?
- notification that the records will be kept centrally - their exact location - name - address - DEA number - type of registration - and whether manual or computerized - and any access codes
What are the HIPAA requirements?
- notify patients about their privacy rights, and about how their information can be used by the pharmacy, which is detailed in the Notice of Privacy Practices - Ensure that pharmacy personnel comply with HIPAA by adopting and implementing procedures for its pharmacy practice and training employees - designating a privacy officer - securing patient records that contain individually identifiable health information and ensuring that they are only available to those who need access to them
Risk summary section in pregnancy/lactation provides what?
- one sentence statement that summarizes the potential of the medication to increase the risk of structural abnormalities, fetal and infant mortality, impaired physiologic function, alterations to growth - states if animal or human data was used - if human data provided goes into greater detail than if animal data provided
What are the computer requirements to be able to store CS refill information?
- online retrieval of original prescription order information - online retrieval of current refill history - documentation that any refill info entered in the computer is correct - capability of printing out refill information - auxillary procedure to document refills in the event of system downtime
Protocol for physician/pharmacist agreement to administer injectables must include what?
- participating pharmacist and prescriber or institution - medication, biological, or immunizations that may be administered - patient or groups of patients to receive the injectables - authorized routes and sites of administration allowed -course of action to follow in emergency situations (like adverse reactions) - length of time the pharmaicst shall observe the individual after injection - location at which pharmacist may administer - recordkeeping requirements and procedures for notification of administration - allowance for termination of the protocol upon request at any time
Information about a patient acquired under OBRA may only be revealed when?
- patient consent - if the Board requires the information - State or Federal law requires it - Court order
Pharmacists may query ABC-MAP for any patient they consider filling CS for, but they MUST check ABC-MAP before filling CS for opioid or benzo for which patients?
- patient is a new patient - patient pays cash when they have insurance - patient requests an early refill - patient is getting opioids or benzos from more than one prescriber
If making intervention through MTM, where does it need to be recorded?
- patient medical record - in pharmacists records - document notification to authorizing physician
What are the labeling requirements for a medication filled in an institution that is not in unit dose packaging?
- patient name - drug name - drug strength - dosing instructions - lot number
What is the required labeling for parenteral, enteral, or total parenteral nutrition products?
- patient name - name, strength, and quantity of each ingredient - diluent - expiration date - pharmacist initials
what are the requirements for giving a package insert when patient is in the hospital?
- patients can be given the insert with each prescription OR - patients can be given the insert with the first dose and then again every thirty days
Board has ability to refuse, revoke, or suspend pharmacy permit if what?
- permit procured through fraud, misrepresentation or deceit - holder or partner or officer has violated any of the provisions of pharmacy act or regulations of board applicable to CSDDCA or CSA or has ordered pharmacist to engage in aspect of pharmacy in contravention of any of the aforesaid acts - holder sold, dispensed, or caused or allowed to be sold any CS or non proprietary drug except by licensed pharmacist - holder fails to comply with all requirements after permit issued - upon suspension or revocation of a license of an employed pharmacist it is shown that the illegal acts of the pharmacist were within knowledge or should have been within knowledge of the permit holder, partner, or officer - pharmacist or pharmacy policy holder entered into agreement with medical practitioner who is licensed to diver patients to or from specific pharmacy - pharmacy's license, permit or registration to conduct a pharmacy or non-resident pharmacy issued by another licensing authority has been revoked or suspended or pharmacy was otherwise disciplined
Which pharmacies are exempt from the definition of online pharmacy?
- pharmacies registered with the DEA whose dispensing of controlled substances via the internet consist solely of refilling CS III, IV, or V - pharmacies filling new prescriptions for CS III-V where the pharmacy had previously filled a non-internet prescription for the same patient and at the patient's request contacts the prescriber for a new prescription
Written protocol for drug therapy management should outline what?
- pharmacist and physician authorized - require that drug therapy regimens be initiated by a licensed pharmacist for patients referred to a pharmacist for drug therapy - identify types of drug therapy management decisions that the pharmacist is authorized to make, including statement of the ailments or diseases involved within physician's scope of practice, types of drug therapy management authorized - describe functions and tasks pharmacist shall follow in course of exercising drug therapy management authority including method for documenting decisions made and plan for communication and feedback to the authorizing physician concerning specific decisions made - rules for providing for the execution of the agreement when any licensed physician or licensed pharmacist may be temporarily absent from a practice setting or temporarily unavailable to participate in its execution
May use an AMS to fill prescriptions or medication orders if what?
- pharmacist manager or pharmacist is under contract with a LTCF which doesn't have a pharmacy onsite, is responsible for the supervision of the operation of the system - if AMS is tested and validated by pharmacy and found to be accurate - if the pharmacy makes the AMS available to the board for the purpose of inspection so the board can validate accuracy
Pharmacy cannot process electronic prescriptions for controlled substances until what?
- pharmacy application provider obtains a third party audit or certification review that determines that the application complies with DEAs requirements - and application provider provides the audit/certification report to the pharmacy
If pharmacy is undergoing alterations, the only way they don't have to close is if what?
- pharmacy takes adequate precautions to protect the health and safety of individuals during the alteration period - plans for the alterations and precautions are submitted to the board at least 30 days prior to the beginning of alteration work and the board raises no objection during that time
Who is allowed to administer methadone in a clinic?
- physician - RN - LPN - RPh - any healthcare professional authorized by federal and state law to administer or dispense opioid drugs operating under the direction of the physician
What are the situations in which a PDR is not required under OBRA 90?
- physician dispenses a drug to a patient being treated in the emergency room - pharmacist dispenses a pharmaceutical to a physician who will administer it to a patient - a medical practitioner dispenses a drug - a pharmacist dispenses a drug to a medical practitioner which the practitioner will administer to a patient
What computer safe guards must be in place?
- those to prevent access by any person who is not authorized to obtain information from the system - identify any modification or manipulation of information concerning a prescription - prevent accidental erasure of information
Which practitioners are exempted from individual registration for CS under the DEA?
- physicians who are officials under the armed service, Public Health Service, and Bureau of Prisons who are also allowed to dispense, administer, and prescribe in the usual course of their official duties - other duly authorized law enforcement personnel who may possess controlled substances as part of their official duties
Written plan for recovery of AMS must include what?
- planning and preparation for a disaster - procedures for response to a disaster - procedures for the maintenance and testing of the written plan for recovery
For all dangerous drugs, what needs to be done in institutional setting?
- policies and procedures need to be developed regarding administration - automatic stop orders shall be established for dangerous drugs not specifically prescribed as to time or number of doses
Where must collaborative agreement be available?
- practice site of physician or pharmacist who is party to the agreement - to any patient whose drug therapy management is affected by the agreement - upon request to the bureau and DOH and filed with the bureau - on the premises of the pharmacy
What are the limits on prescribing of opiates for ER patients/urgent care patients/those in observation status in a hospital? What are the exceptions?
- practitioner may not prescribe more than 7 days supply of opioid and is not permitted to prescribe refills - exception if prescriber thinks it is necessary with professional judgement or is treating pain associated with a cancer diagnosis, palliative care - can issue quantity needed in these situations as long as documented in medical record and note that a non-opioid was inadequate treatment
Authorized agent of a prescriber may do what?
- prepare a controlled substance prescription for signature of prescriber - orally communicate a prescribers CIII-CV prescription to a pharmacist or via practitioner signed fax - transmit by fax a prescribers written CII prescription to a pharmacist for a patient in hospice or LTCF
Physical copy of emergency CII script needs to be delivered to the pharmacy within what time frame? What does it need to have on it? HOw does PA law differ on this issue?
- prescriber must deliver or postmark prescription to the pharmacy within 7 days - with the words "Authorization for emergency dispensing." - PA law says delivery of hard copy cover must be within 72 hours
What are the DEA requirements for TRANSMITTING pharmacies taking part in central filling?
- prescription can be transmitted electronically to central fill pharmacy - must write central fill pharmacy on face of prescription and record the name, address, and DEA number of the central fill pharmacy - record name of transmitting pharmacist - record date of transmission - transmitting pharmacy must keep record of receipt of the filled prescription, including date of receipt, method of delivery, name of employee accepting delivery
What drug products are subject to labeling requirements?
- prescription drug products that are sold to or used in hospitals - biological products - OTC drug products that are dispensed pursuant to an order and are packaged or labeled for hospital use or marketed, promoted, or sold to hospitals
In order for a prescription to be transferred, it must meet what requirements?
- prescription is for a drug that is lawfully refillable - drug is not a CII - an original or new script is not required from the prescriber by law
Medicaid prescriptions are required to be tamper resistant which means it must have what characteristics?
- prevent unauthorized copying of completed or blank prescription forms - prevent erasure or modification of information written on the prescription - prevent the use of counterfeit prescription forms
What are the unlawful acts under section 8 of Pharmacy Act?
- procure or attempt to procure license permit or certificate for himself or any other person under false representations - any person not duly licensed as a pharmacist to engage in practice of pharmacy - pharmacist that doesn't dispense emergency prescription proeprly - unlicensed person operating or conducting or taking charge or supervising pharmacy (owner liable as well) - any person representing themself to be licensed when they are not - any person knowingly preventing or refusing to permit any member of board or its agents from entering a pharmacy for inspection - any person who's license, permit, or certificate has been revoked, suspended, or refused renewal to fail to deliver same to board upon demand - any person to sell at auction drugs or devices unless sale has been approved in advance by board and and sale is under supervision of pharmacist - any person, firm, or corporation using the title "pharmacist" (or similar) or "pharmacy" (or similar) unless pharmacy duly issued a permit - buying, selling, or offering to sell sample or drug/device labeled as not for resale or investigational - any person using to own advantage or reselling trade secrets to anyone other than board, representatives, or courts - advertising or promoting prices for drugs and pharmaceutical services to public that don't conform to federal laws or regs - any person counterfeiting goods or keeping in possession with intent to defraud purchasers or manufacturers - any person by himself or another attempting to procure any drug by fraud, deceit, misrepresentation, forgery or alteration of script, concealment of material fact, use of false statement in any prescription order or report - any person to advertise filling or refilling of scripts if person is not licensed in PA or pharmacy not licensed by board - one or more medical practitioners having proprietary or beneficial interest to permit them to exercise supervision or control over pharmacist
Ability to refuse, revoke, or suspend pharmacist license if what?
- procured license through fraud, misrepresentation or deceit - found guilty, pleaded, guilty, entered plea of nolo contendere or has received probation without verdict, disposition in lieu of trail or an ARD in disposition of felony charges to any offense in connection with the practice of pharmacy or any offense involving moral turpitude - unfit to practice due to use of alcohol or drugs - unit to practice due to physical or mental disease or disability - has had license in any other state revoked or suspended - violated or knowingly permitted the violation of any provision of this act or regulation of the board - has knowingly allowed an unlicensed person to take charge of a pharmacy or engage in compounding or dispensing - compounding drug in amounts not specified by prescriber or brand or trade name different than what prescriber stated - has license to practice suspended, revoked, or refused, or received other disciplinary action by another state, territory, or county - presents immediate and clear danger to public health or safety - is guilty of incompetence, gross negligence, or other malpractice or failing to comply to acceptable practice, in which case don't need actual injury - is guilty of grossly unprofessional conduct
If pharmacy is to work with LTCF and medicare is to participate, what services must the pharmacist provide for the facility?
- provide consultation on aspects of the provision of pharmacy services in the facility - establish a system of records of receipt and disposition of all CS in sufficient detail to enable an accurate reconciliation - determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled
What are the requirements (REMS) for prescribing/dispensing transmucosal immediate release fentanyl?
- providers who prescribe TIRF for outpatient use need to be specially certified - pharmacies who dispense TIRF need to be specially certified
A computerized system for recording and maintaining information concerning prescriptions must be designed so that it is capable of what?
- providing immediate retrieval by means of monitor, hard copy printout, or transfer medium of patient information for all prescriptions filled within past 12 months - retrieval within 3 working days of all prescriptions dispensed from 12-24 months from the last activity date including information normally required to be on a prescription and identification of the pharmacist responsible for prescription information entered into the computer system
What needs to be entered in a SLCP logbook? What must be done during purchase of SLCP
- purchaser signature - purchaser name, address, date/time of sale - retailer checks photo ID - enters name of product and quantity
When considering whether CS theft or loss is significant, what factors need to be considered?
- quantity of CS missing - specific CS missing - whether loss can be associated with access to the CS by individuals or whether loss can be attributed to activities taking place involving those CS - pattern of losses over a specific time period, whether random or not, and the results of efforts taken to resolve the losses - if the CS is a candidate for theft or diversion - local trends and other indicators of the theft or diversion potential of the missing CS
in PA, what is the rule with prescription refills and therapeutic equivalence?
- refills shall be completed using identical product (same distributor and manufacturer) as dispensed on the original, unless the person presenting the prescription and the practitioner authorize in advance a different manufacturers generic equivalent product
What supplies are *required* in a pharmacy?
- refrigerator in prescription area used only for drugs, equipped with thermometer or temperature monitoring device - space for substantially constructed cabinet or safe for storage of CS, unless they are dispersed through stock - sink - at least one telephone (which has number that matches what's on prescription label) - prescription files kept in accordance with state and federal laws and regs - original prescription or image of the original prescription, which needs to be retained for 2 years from the date of the most recent filling - additional equipment and supplies necessary and consistent with the pharmacy's scope of practice - reference materials as enumerated
Non-resident pharmacies must meet what operational requirements?
- regular hours of operation but not less than 6 days per week and minimum 40 hours per week - provide toll-free telephone number to facilitate communication with patients in the commonwealth - toll-free number disclosed on label affixed to each container of drugs dispensed to patients in PA
What did the Prescription Drug Marketing Act do when it was enacted?
- regulate the handling of prescription drug samples - regulatesthe purchase and re-sales of drugs by hospitals, health care entities, and charitable institutions - requires licensing of all drug wholesalers
What are some examples of things that would need to be included in an accounting of disclosures?
- reporting to a vaccination database - information submitted to Workmen's Compensation - misdirected faxes or emails
Electronic order for controlled substances on CSOS may not be filled if what?
- required data fields not completed - order not signed using a digital signature issued by DEA - digital certificate has expired or been revoked prior to signature - purchaser's public key will not validate the digital certificate - validation of the order shows that the order is invalid for any reason
What did the Safe Medical Device Act of 1990 do?
- required device user facilities like hospitals to report deaths or serious injuries or illnesses caused by a device within 10 working days to the manufacturer or the FDA if the manufacturer is unknown (if death need to report to both FDA and manufacturer definitely)
What did Kefauver Harris Amendment do?
- required more carefully controlled clinical studies - imposed the additional requirement that drugs be effective in addition to safety requirement imposed by original FD&C Act - established good manufacturing practices - increased inspection authority of the FDA
If CS prescription is filled at a central fill pharmacy, what label must be attached?
- retail pharmacy name and address - unique identifier (like central fill pharmacy DEA number indicating that the prescription was filled at the central fill pharmacy
Pharmacist must supervise interns and techs, meaning what?
- review prescriptions or orders prior to dispensing - verify the final product - be immediately available on the premises to direct the work and respond to questions or problems
Patient's healthcare information can only be disclosed for what reasons?
- to provide health care to the patient - obtain payment for the health care services provided - or in connection with the day to day operations of the pharmacy
Minimum size of a prescription area must be how large?
250 square feet
Pharmacist manager or pharmacist under contract with LTCF is responsible for what in terms of AMS?
- reviewing and approving all policies and procedures for system operation, safety, security, accuracy, access, and patient confidentiality - assigning, discontinuing, or changing personnel access to AMS - ensuring AMS is stocked accurately and an accountability record is maintained in accordance with the written polices and procedures - ensuring compliance with applicable provisions of State and Federal law
Under HIPAA patients have what rights?
- right to access their PHI (individual prescriptions, cumulative Rx record, patient profile information) - right to request that their records be amended - right to accounting of disclosures
What are the three subsections now listed under pregnancy and breastfeeding?
- risk summary - clinical considerations - data section
Prescription drug resale (i.e. hospital buys and then sells) is only allowed in what situations?
- sales to non-profit affiliates, sales to/from other member hospitals of a group buying organization - emergency sales or transfers to a community pharmacy experiencing a temporary shortage of prescription drug - sales pursuant to an outpatient prescription in the hospital
What are the exceptions to needing the original Rx for faxed CII scripts?
- schedule II to be compounded for direct administration to a patient by parenteral, IV, IM, SC, or intra-spinal infusion - schedule II narcotic for hospice patient - schedule II substance for patient in LTCF
What are the specific functions of the P&T committee?
- serve as an advisory group to medical staff and pharmacists on the choice of drugs - develop and review periodically a formulary or drug list - recommend standards regarding the use and control of investigational drugs - recommend standards concerning research in the use of recognized drugs - evaluate clinical data concerning new drugs or preparations requested - make recommendations on drugs stocked on the nursing unit floors - establish procedures which will prevent unnecessary duplication in stocking drugs having identical amounts of the same therapeutic ingredients - make recommendations concerning drugs that need automatic stop orders - make recommendations regarding proper P&P on the administration of drugs
Satellite pharmacy does not include a pharmacy that does what?
- serves the public on the premises of the institution - which is located off premises from the centrally located pharmacy
In order for pharmacist to substitute biological products, need to display what at pharmacy?
- sign saying PA law permits pharmacists to substitute a less expensive interchangeable biological product - list of commonly used interchangeable biological products containing the generic names and brand names where applicable - pricing list of brand and interchangeable biological products
If pharmacy places emergency kit in LTCF and is approved, must have procedures that delineate what?
- source from which LTCF obtains CS for emergency kits and that the source is DEA registered hospital/clinic/pharmacy/practitioner - security safeguards for each emergency kit including who may have access to the kit and specific limitation on the type and quantity of CS permitted in the kit - responsibility for proper control and accountability including requirement that LTCF and registrant maintain accurate records of CS and inventories - emergency medical conditions under which the CS can be administered and requirement it be by authorized personnel only as expressly authorized by individual practitioner (through executed order) - prohibited acitivities that if violated could result in state revocation, denial, or suspension of the privelege to supply or possess emergency kits containing CS
What are the options for ETASU?
- special training and/or certification requirements for prescribers or dispensers of the drug - restricting distribution of the drug to particular care settings - dispensing a drug based on evidence or documentation of safe use conditions (like patient counseling and acknowledgement using informed consent form) - patient monitoring and follow-up (lab testing) - patient registries
Authorization for disclosure of PHI must be separately signed and dated and contain what other information?
- specific and meaningful description of the PHI to be used or disclosed - names or specific identification of the persons or entities to whom the PHI will be disclosed - description of each purpose for which PHI will be used or disclosed - expiration date or event after which the authorization will no longer be valid - patient's signature and the date signed
Under the CSA before an inspection, what is an inspector required to do?
- state the purpose of the inspection - present credentials - provide a written notice of inspection
Ryan Haight also requires that online pharmacies have what?
- statement that the pharmacy complies with the act - name, address, e-mail address, telephone number - name, professional degree, states of licensure for the pharmacist in charge and telephone number at which PIC can be contacted - list of states in which the pharmacy is licensed - certification that pharmacy is registered with DEA as online pharmacy - name, address, telephone #, professional degree, and states of licensure of any practitioner who has contractual relationship with the pharmacy - and additional online statement *all on home page*
What is the required content in an IND for individual patient use?
- statement that this is a request for an individual patient IND for treatment use - brief clinical history of the patient - proposed treatment plan - chemistry, manufacturing, controls information, pharmacology and toxicology info (can obtain by getting letter of authorization from the manufacturer based on what has previously been submitted to FDA under existing IND or NDA) - informed consent - approval of the use by appropriate institutional Review Board (IRB) will be obtained prior to treatment - investigator qualification statement that specifies the training, experience, and licensure of the treating physician (i.e. CV) - FDA form 1571 completed with the treating physician listed as the sponsor - contact telephone number and facsimile number
Sole pharmacist may take a 30 minute break as long as what?
- stay in immediate building - still be available for counseling emergencies - pharmacy can remain open during break to receive new scripts, prepare Rxs for final verifiation, deliver Rxs already verified
What are some typical uses of tax free alcohol in a hospital?
- sterilizing solutions - antiseptic - vehicle in compounding prescriptions - preparation of specimens
What is Phase I of clinical testing in humans?
- studies performed on small number of healthy persons (20-80) and used to determine the pharmacology of the drug and it's toxicology, NOT efficacy
Course used to meet education requirements for authorization to administer injectables must contain what?
- study material - hands on training and techniques for administration - testing with a passing score - minimum of 10 hours of instruction and experiential training - compliance with guidelines and recommendations from CDC, ACPE , or similar health authority or professional body
What is the application procedure for authorization to administer injectables?
- submit application and applicable fee - certification of having completed required education and training - certification of holding current CPR certificate
When transferring business activity to another person what must happen in regards to CS?
- submit proposal to DEA 14 days in advance and include name, address, DEA number of the registrant discontinuing the business and the same information for the registrant acquiring the business - include whether the business activities will continue at the current location or at another location
Policies and procedures on the operation of AMS created or adopted by pharmacy must contain what?
- tablet of contents - description of all procedures of operation - identification of the circumstances under which medications may be removed from the AMS by a licensed medical practitioner for distribution to a patient without prior order review by a licensed pharmacist
What is specifically listed as not allowed in a pharmacy?
- television within view of prescription area - no pets (except guard dog for security) - no storage in the prescription area of merchandise other than that used in the preparation, dispensing, or delivery of drugs and no access for unauthorized personnel
Authorization for disclosure of PHI must also include what statements?
- that it is the individual's right to revoke the authorization in writing - that the pharmacy is unable to condition filling the individuals prescriptions on the basis of whether they sign the authorization - that there is a potential for the information that is subject of the authorization to be re-disclosed if the receiving party is not subject to HIPAA requirements
What are the 4 nutritional support statements that the DSHEA allows?
- that the product will benefit a classical nutrient deficiency disease as long as it also discloses the prevalence of the disease in the US - description of the role of the dietary supplement in affecting the structure or function of the body - characterization of the documented mechanism by which a nutrient or dietary supplement acts to maintain structure or function - description of the general well-being from consumption of a nutrient or dietary supplement (like an energizer)
Central fill pharmacy may fulfill request to process, fill, or refill prescription from pharmacy or patient or prescriber and may deliver as long as what requirements are met?
- the central fill pharmacy has a contract with or has the same owner as the originating pharmacy and the delivering pharmacy (including confidentiality of patient information) - prescription container must show name, address, telephone number and DEA number of the delivering pharmacy - share common electronic file with the pharmacies engaging in centralized prescription processing - each pharmacy engaging in central filling will be jointly responsible for properly filling the prescription
If a patient requests a copy of an original prescription, what requirements apply?
- the copy shall clearly indicate on face of script that it is a copy and may not be used to obtain a new prescription or refill - person requesting copy shall show the pharmacist acceptable authorization and identification, like drivers license - pharmacist shall record in writing the date, to whom, and by whom the copy was given
Advertising of filling/refilling prescriptions is only permissible if what?
- the person is licensed in PA - or the prescription is filled or refilled in a pharmacy licensed by the Board
What are the potential drug therapy problems a PDR is used to catch?
- therapeutic duplication - drug-drug interactions - incorrect dosage - incorrect duration of treatment - drug-allergy interactions - clinical abuse or misuse
Which pharmacies are eligible to participate in the Cancer drug repository program?
- those that hold current unrestricted permit and are in good standing to operate as a pharmacy in the common wealth - delegates to pharmacist employed or under contract with the pharmacy the responsibility to receive delivery of donated cancer drugs - agrees to participate in the program in accordance with applicable laws and regulations
Therapeutically certified optometrists can prescribe what?
- topical anesthetics - topical ocular lubricants - topical ophthalmic dyes and stains - topical hyper-osmotic agents - topical autonomic drugs - topical NSAIDs - topical antimicrobials - topical and oral analgesics - topical anti-allergy (antihistamines and mast cell stabilizers) - topical steroids and oral steroids (prednisone and methylprednisolone) - topical immunomodulators
Practitioner may authorize additional refills on CIII-CV prescriptions provided what?
- total quantity authorized, including that on the original does not exceed 5 refills nor extend beyond 6 months from the date of issue - pharmacist initials and record the date, quantity authorized, and number of additional refills authorized on the reverse side of the original prescription - quantity of additional refill is equal to or less than the quantity authorized for the initial filling - new prescription is required for any refills beyond the 6 month, 5 refill limit
Once pharmacy requests help from Special Agent in Charge for destruction of CS, what may the special agent in charge instruct the pharmacy to do?
- transfer to a registrant authorized to transport or destroy the substances - delivery to an agent of the Administration or to the nearest office of the Administration - destruction in the presence of an agent in the administration or other authorized person
What requirements does pharmacist need to have under collaborative agreement?
- utilize area for in person, telephone, or other approved electronic consultations to ensure confidentiality - initiate management only upon written referral from physician, and referral needs to indicate minimum frequency of in-person management of drug therapy - verify that physicians license is active and unrestricted and that agreeement is within scope of practice at the time of signing the agreement
What must transferRING pharmacist record on prescription?
- void on face of prescription - name, address, and DEA of transferee pharmacy - name of the transferee pharmacist - date prescription was transferred - pharmacist that transferred the prescription
Besides registration, what are the other components of the No blood, no drug program?
- weekly testing - patient database - ongoing compliance monitoring and feedback
What constitutes grossly unprofessional conduct?
- willfully deceiving or attempting to deceive state board of pharmacy - advertising prices for drugs that doesn't conform to federal laws or regulations - public assertion or implication of professional superiority - engaging in untrue, false or misleading or deceptive advertising - paying rebates to any other persons or entering into any agreement with any other person for the payment or acceptance of compensation in any form for the recommending of the professional services of either party - entering into of any agreement with any licensed medical practitioner for the compounding, dispensing of secret formula (coded) prescriptions - misbranding or adulteration - engaging in the sale of samples of drugs - displaying or permitting the display of one's licensure and biennial registration document in a pharmacy of which he/she is not a proprietor or where not employed - any holder of biennial pocket registration card who fails to have the card available for inspection by authorized agent when he/she is practicing - acceptance back and redistribution of any unused drug after it has left the premises of any pharmacy unless sealed original - accepting employment as a pharmacist and receiving compensation from medical practitioner to allow them to have control over pharmacist - accepting employment and compensation from any person who order a pharamcist to engage in pharmacy practice in contravention to pharmacy act - entering into arrangement with medical practitioner who is listed to issue prescriptions for purpose of diverting patients to or from specified pharmacy or restricting patient's freedom of choice
LTCF needs to have what for emergency kit?
- written policies and procedures pertaining to use, content, storage, and refill of emergency kit
What did the Medical Device Amendments of 1976 do?
-established criteria for classifying devices into one of three categories and required various controls on devices based on evaluation of their function -required pre-marketing approval and classification of devices
Under the CSAT/SAMHSA program, what are the requirements?
-practitioners intending to treat opioid addiction must apply for certification by CSAT and applicable state methadone authority - certification determined by accreditation body that evaluates whether the OTP meets the required standards
There are how many forms required for documentation of the activities in cancer drug repository program?
1 form for all 4 Ds
How long must female be on 2 forms of contraception before receiving an initial isotretinoin prescription? How long after does she need to stay on these 2 forms of contraception?
1 month before use, during use of isotretinoin, and for one month after stopping isotretinoin
What is usual dosage of Ipecac syrup?
1 tablespoon (15 milliliters) in persons over 1 year of age
A prescription drug written for PRN or ad lib refills may be refilled how long from date of the prescription?
1 year
Prescriptions may be refilled how long from the date of the prescription if refills have been authorized?
1 year
How many tablets of Sudafed 30 mg (Pseudoephedrine HCl) can be purchased?
146
Buyer of a poisonous substance must be of what age?
16 or older
pharmacist may administer injectables, biologicals, or immunizations to persons who are of what age?
18 years old; only allowed to administer *flu vaccine* to children age 9 and older
When did Kefauver Harris Amendment go into effect?
1962
Upon written request from the DEA, the registrant must supply central records to the registered location within what time frame?
2 days
Prescribers writing prescriptions for controlled substances are required to use what to autheticate prescription?
2 factor authetication (DEA allows 2 of the following: knowledge factor like password, hard token stored separately from computer being accessed, or something you are (biometric information))
What is DEA number comprised of?
2 letters, 7 numbers
How many negative pregnancy tests must a female of childbearing potential have before receiving isotretinoin?
2 negative urine or blood pregnancy tests
All controlled substance records required to be maintained must be kept by the registrant for a period of how long?
2 years
Copies of records of all adverse drug reactions and drug sensitivities in the institutional setting will be kept in the pharmacy how long?
2 years
How long must inventory records of controlled substances be maintained?
2 years
If CII is dispensed in an institution and the patient received, how long do records of this need to be kept?
2 years
What is the required retention period for records associated with cancer drug repository program?
2 years
Original prescriptions need to be kept how long?
2 years (if refilled, need to keep 2 years from the date of last refill)
Patient profile needs to be maintained for how long?
2 years after last entry
Any amendments, additions, deletions, or other changes to policies and procedures of operation for AMS need to be retained how long?
2 years after then change is made
SLCP logbook entries must be maintained how long?
2 years following the date of entry
Records related to administration of immunizations/injectables needs to be maintained how long?
2 years minimum
How much base is in 25 mg ephedrine?
20.57 mg
How much base is in 30 mg pseudoephedrine SO4?
23.22 mg
How much base is in 30 mg pseudoephedrine HCl?
24.65 mg
Drug recalls are divided into what?
3 classes
Mouthwashes OTC must be in CRC if what amount?
3 grams or more of ethanol in a single package
Individuals applying for initial license need how many hours in child abuse recognition training and reporting requirements?
3 hours
What is the daily sales limit of SLCPs?
3.6 grams (base) per day per purchaser regardless of the number of transactions
Pharmacist must complete how many CE hours per renewal period?
30 CE hours
Online pharmacies need to be registered with the DEA how long before engaging in internet pharmacy involving CS?
30 days
If having trouble finding new pharmacy manager, can request extension of how long?
30 days; have to make request in writing
Currently, med guides are required for over how many products?
300
When was Ryan Haight Act effective?
4/13/2009
If injectable is given pursuant to an order, need to notify *PCP* within what time frame?
48 hours
What is the time frame in which printout of CS refill information must be retrieved from central storage and provided, if requested?
48 hours
Prescriber needs to be notified in what time frame if order is automatically stopped in institutional setting?
48 hours before order is stopped
Poisons are divided into what schedules?
A and B
For physician, what are the options for first letter in DEA number?
A, B, F, G
How soon do drug therapy management interventions need to be documented?
ASAP, but no later than 72 hours after
What act states that persons applying for licensure need to complete 3 hours of child abuse training? Who regulates this?
Act 31 of 2014; states that BPOA and DHS are required to ensure this happens
What is the other name for Orange book?
Approved Drug Products with Therapeutic Equivalence Evaluations
Who can deny registration to dispense CS if it is determined registration would not be in public interest?
Attorney General
Who has the authority to set the schedule of a medication?
Attorney General
If sales person violates sales, training, certification requirements when it comes to SLCPs, who can do what?
Attorney General can prohibit further selling by this individual
Who can revoke CS registration?
Attorney General, DEA
When did tramadol become CIV?
August 18, 2014
Retail pharmacies are typically inspected by who?
Board of Pharmacy
Upon request, pharmacy must provide written policies and procedures on AMS to who?
Board of pharmacy for inspection and review
If pharmacist is licensed in multiple states, must report this to who?
Board of pharmacy on biennial registration application
Midwife abbreviation?
C.N.M.
Certified Registered Nurse Practitioner abbreviation?
C.R.N.P.
Need to administer injectables/immunizations in accordance with guidelines from who?
CDC
Compounders cannot ask for exemptions from what if they are an outsourcing facility?
CGMPs
ABC-MAP contains information on CS in what schedules?
CII-CV
Subutex and Suboxone are what schedule CS?
CIII
Optometrists with therapeutic license can prescribe what CS?
CIII-CV
Any OTC drugs that were previously available by prescription must have what kind of packaging?
CRC
Which prescribers have limited authority to prescribe?
CRNP, PA, OD
Dangerous drugs include what?
CS, sedatives, anticoagulants, antibiotics, oxytocics, and corticosteroids
Inspections from State Board of pharmacy and DOH can or cannot be refused?
Cannot
Who determined it was in public interest for Ipecac syrup to be available without prescription?
Commissioner of the FDA
Who enforces the Poison Prevention Packaging Act?
Consumer Product Safety Commission (CPSC) NOT THE FDA
Minoxidil OTC preparations must be in CRC if what amount?
Containing more than 14 mg in a single retail package
Ketoprofen OTC preparations must be in CRC if what amount?
Containing more than 50 mg in a single package
Doctor of Dental Surgery abbreviation?
D.D.S.
Doctor of Dental Medicine abbreviation?
D.M.D.
Doctor of Osteopathy abbreviation?
D.O.
Doctor of Podiatric Medicine abbreviation?
D.P.M.
Doctor of Veterinary Medicine abbreviation?
D.V.M.
Individuals who prescribe CS should also register with who?
DEA
What is Ryzodeg?
Degludec + aspart insulin
Hospital pharmacies are primarily inspected by who?
Dept of Health (but may be inspected by the Board of Pharmacy)
Hospital pharmacies are insepected by who? Who can this agency report to and what could it mean?
Dept of Health; DOH can report findings to state board who can follow up with their own inspection
Must document what in regards to cancer drug repository program (4 Ds)?
Donation, Dispensing, Distribution, Destruction
Waxman Hatch Amendment is also known as what?
Drug Price Competition and Patent Term Restoration Act of 1984
What was passed by congress in response to NECC disaster?
Drug Quality and Security Act
Who has authority over compounded medications now after FDAMA?
FDA
Who regulates the advertising of prescription drugs?
FDA
Are USP recommendations on unit dose packaging supported by FDA in law?
FDA issued policy guide to reflect USP stance on unit dose packaging, but never finalized
What is the OTC monograph process?
FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs (like antidiarrheals, analgesics, antacids) instead of individual drug products and for each category and monograph is developed and published in the Federal Register
Controlled Substance Registration Protection Act mandates what?
Federal investigation must occur if - replacement cost of CS taken is $500 or greater - registrant or other person is killed or suffers significant injury - Interstate or foreign commerce is involved in the planning or execution of the crime
Compounding provisions were included in what act? When did it take effect?
Food & Drug Administration Modernization Act (FDAMA); 1998
Loperamide OTC must be in CRC if what amount?
Greater than 0.045 mg/single package of an oral dosage form
HIPAA stands for what?
Health Insurance Portability and Accountability Act
Which insulins are available without a prescription
Humulin and Novolin
If a manufacturer cannot make a drug to comply with an OTC monograph then they need what?
IND application and approved NDA is necessary before the manufacturer can market the drug product
What is the only exception to the time the Attorney General doesn't have to consult the Secretary of the Dept of HHS on scheduling a drug?
If the drug must be placed into schedule I to avoid an "imminent hazard to public safety"
What is an example of interstate/foreign commerce being involved in a crime?
If the robbery was planned in NJ and carried out in PA or if robbery was carried out in PA and perpetrators fled across state lines to NJ
How are prescriptions deemed "readily retrievable"?
If when they are initially filled - the face of the script is stamped in red ink in the lower right corner with the letter C no less than 1 inch high - filed in the prescription file for controlled substances listed in schedule II - in the usual consecutively numbered prescription file for non-controlled substances
When was carisoprodol made a schedule IV?
January 2012
Final rule on electronic prescriptions for controlled substances became effective when?
June 1, 2010
When did governor wolf sign into legislature that pharmacists could give flu shots to kids age 9 and older?
June 2015
When was biosimilar substitution bill (act 95) signed into effect?
June 2016
Prescription Monitoring Law was signed into law and became effective when?
June 30, 2015 effective and was operational August 2016
Authorized hospitals/clinics and retail pharmacies may maintain collection receptacles where?
LTC Facilities
CS Collection events are reserved only for who?
Law enforcement (but pharmacy may partner with law enforcement to hold take back event)
What does the Secure and Responsible Drug Disposal Act of 2010 do?
Legal provisions for patients to dispose of unwanted pharmaceutical controlled substances (prior to this could only give them to law enforcement and pharmacies, doctor's offices, and hospitals were not allowed to accept them)
Mid level practitioner DEA numbers begin with what letter?
M
Doctor of Medicine abbreviation?
M.D.
Methylprednisolone tablets are exempt from PPPA in what amount?
NMT 84 mg of drug per package
FDA has adopted what as the preferred method of communicating information about a drug to a patient?
Medication Guide
Mebendazole tablets are exempt from PPPA in what quantity?
NMT 600 mg of drug per package
Lidocaine must be in CRC if what amount OTC?
More than 5.0 mg in a single package
Erythromycin ethyl succinate granules for oral suspension and oral suspensions are exempt from PPPA in what amount?
NMT 8 grams of the equivalent of erythromycin per package
What is the wording required on a prescription about brand necessary requirements?
Must say "IN ORDER FOR A BRAND NAME PRODUCT TO BE DISPENSED, THE PRESCRIBER MUST HANDWRITE "BRAND NECESSARY" OR "BRAND MEDICALLY NECESSARY" IN THE SPACE BELOW" in 8 point, upper case print
After completion of internship, foreign graduates are subject to what examination?
NAPLEX and MPJE same as american grads
If a product is marketed as a drug (i.e. with intent to diagnose, cure, treat, or prevent disease) then the FDA considers it a drug and it is subject to what?
NDA requirements; etc
Prednisone tablets are exempt from PPPA in what amount?
NMT 105 mg per package
Sodium fluoride products are exempt from PPPA in what amount?
NMT 110 mg of sodium fluoride per package (equivalent of 50 mg of elemental fluoride per package)
Betamethasone tablets are exempt from PPPA in what amount?
NMT 12.6 mg of the drug per package
Erythromycin ethyl succinate tablets are exempt from PPPA in what amount?
NMT 16 grams of drug per package
Conjugated estrogen tablets when dispensed in mnemonic dispenser packages are exempt from PPPA in what amount?
NMT 32 mg of the drug
Potassium supplements in unit dose form including effervescent tablets, unit dose vials of liquid potassium, and powdered potassium in unit dose packets are exempt from PPPA in what amount?
NMT 50 mEq per unit dose
Norethindrone acetate tablets in mnemonic dispenser packages are exempt from PPPA in what amount?
NMT 50 mg of the drug
Are optometrists allowed to prescribe CIIs?
NO
Are pharmacists required to register individually for controlled substance activity?
NO
Are there requirements for counter length if multiple technicians or interns present?
NO
Can FDA order drug recalls?
NO
Can an Administrative Inspection Warrant be refused?
NO
Can cancer drugs donated under the Cancer Drug Repository program be resold?
NO
Do you need to log sale of schedule A poison if it is pursuant to a prescription?
NO
Does a compounded product need need to be a copy of a commercially available product?
NO
Does allowance for emergency dispensing apply to CS as well?
NO
Does supervising pharmacist in a pharmacy college internship program need to be a preceptor?
NO
IF regular FDA inspection is given can the pharmacy owner refuse the inspector access to the pharmacy?
NO
If you complete excess hours of CE will they carry over to the next renewal period?
NO
Is promoting the sale of CS okay?
NO
Under federal law are there any quantity limits on CS prescriptions?
NO
Under federal law is there a time limit during which a CII must be filled?
NO
Is NDC number required on bulk prescription container labels?
NO (suprisingly); but it is requested on all prescription and OTC drug labels and labeling
Is a pharmacist required to counsel on refill prescriptions?
NO (surprisingly)
Under DQSA, do traditional compounding pharmacies (those that compound based on individual prescriptions) need to comply with GMPs? Need to seek FDA approval of their products they compound? What is the only requirement they must meet?
NO to both; must only put physician specified directions on the label to comply with adequate directions for use requirement
If there is an error on made on DEA 222 form, what does the purchaser have to do?
NO white out, alterations, erasures are permitted; need to write VOID on all copies and keep stored; use new order form
Are pharmacy owners required to submit plans for changing location of a pharmacy to the Board?
NO, but either way the new pharmacy will require inspection and approval by the board prior to opening for business
If it is an emergency does the pharmacist have to obtain advanced authorization to substitute different manufacturer/distributor drug from the original?
NO, but should notify physician as soon as possible thereafter
Does a hospital registered with the DEA have to have separate DEA registrations for decentralized pharmacy services or satellite pharmacies?
NO; as long as they are all part of the same physical structure
Currently, do Plan B and generic equivalents have an age requirement?
NO; available OTC with no age restriction
Do all manufacturers of clozapine have the same registry program?
NO; but all are similar
Is it a federal or state law to lock up schedule II drugs?
NO; but is legitimate precaution
Are requests for e-z open containers required to be in writing?
NO; but strongly encouraged by CPSC
Does the FDA have the authority to issue a drug recall? What can they do?
NO; but they will either ask a company to initiate one in lieu of injunctive relief or seizure, which the FDA can undertake if a company does not respond to their request
If a search warrant is issued do the "reasonable" limits on inspections apply?
NO; can be served any time of day or night
If pharmacist fills electronic controlled script, do they have to print out and notate on the script if it is required?
NO; can make the notation electronically and retain annotation electronically in the prescription record or linked to files
Can drugs that were picked up be returned to stock?
NO; grossly unprofessional conduct
If prescriber is deceased are scripts previously written under them allowed to be filled?
NO; not knowingly (if pharmacist does not know then cannot fault them, but should pay attention to deceased prescribers; "doc is dead, so is the script")
Is it required to record the signature of those taking inventory?
NO; not required, but recommended
Is orange book federal law?
NO; only used as a guide to states as they enact their own substitution laws and regulations
If license, certificate, or registration of a person to practice pharmacy has been revoked, can the board reverse this? What is allowed to happen?
NO; person may apply for reinstatement after a period of at least 5 years, but must meet all licensing qualifications, including examination requirement
Can pharmacist delegate the administration of injectables to another person?
NO; pharmacist is the only one who can administer
Do patients pay for drugs during an investigational study?
NO; sponsor needs to get special approval from FDA if they want to charge a patient for the investigational drug
If physician orders alcoholic drink at bedtime for a patient, what alcohol can be used?
NOT tax free alcohol; must use alcohol supplied by the family or traditional alcohol supplied by a liquor store
Pharmacists need to look for what before dispensing Lotronex prescription? How can prescriptions be accepted?
Need to look for PPL sticker which provides verification to the pharmacist that the prescription is written by a certified prescriber enrolled in PPL; Cannot accept telephone, fax, or computerized scripts for Lotronex, NEEDS TO BE HARD COPY
Does a certain method have to be utilized for destruction of CS under the Final Rule on Destruction of CS?
No, but must be rendered non-retrievable (unavailable, unusable, not capable of being transformed into a CS)
Is a pedigree required under FDA?
No; PDMA now doesn't allow because a court ruled it had an unfair economic impact on secondary wholesalers
Per PA regulations are there quantity limits on CII scripts?
No; but pharmacist is responsible as part of corresponding responsibility to ensure any quantity written for is reasonable
Are electronic orders on the DEA CSOS mandatory?
No; optional, registrants may continue to use paper DEA form 222
Do pharmacy supplies in institutional setting differ from those described for retail settings? How about space and sanitary requirements
No; outlined in PA pharmacy regulations
Are there age requirements for purchasing SLCP products?
Not federally; some states impose an age requirement
When did DQSA become effecive?
November 27, 2013
Optometrist abbreviation?
O.D.
Residents of LTCF need written physician order for each medication received including what?
OTC meds
When did hydrocodone products change from schedule III to schedule II?
October 6, 2014
HIPPA is enforced by who?
Office of civil rights
Wholesaler DEA numbers begin with what letter?
P or R
Staff involved in administration of resident care in LTCF need to be knowledgeable in what?
P&P regarding pharmacy services including med administration
Physician Assistant abbreviation?
P.A. or PA-C
What agency is responsible for Pharmacy Act? What regulation is this under?
PA Board of Pharmacy; Title 49, Chapter 27
What agency is responsible for Controlled Substances Drug Device and Cosmetic Act? What regulation is this under?
PA Dept of Health; Title 28, Chapter 25
Who signed standing order for prescription naloxone? Under what Act? When?
Physician General of PA; Act 139; October 28, 2015
What is the REMS program for Lotronex (Alosetron) called?
Prescribing Program for Lotronex (PPL)
Under OBRA 90 a pharmacist shall perform what before filling, delivering, or sending a new prescription or drug order
Prospective drug review (PDR)
What schedule drug is methadone (dolophine)?
Schedule II
DEA CSOS uses what technology? What does this mean?
Public Key Infrastructure (PKI) which means users need to obtain CSOS digital certificate for electronic ordering
Clinicians who wish to prescribe thalidomide have to register with what?
STEPS Prescriber Registry
What schedule drug is GHB (Gamma hydroxybutyric acid)?
Schedule I
What schedule drug is LSD?
Schedule I
What schedule drug is THC?
Schedule I
What schedule drug is heroin?
Schedule I
What schedule drug is marijuana?
Schedule I
What schedule drug is mescaline?
Schedule I
What schedule drug is methaqualone?
Schedule I
What schedule drug is peyote?
Schedule I
What schedule drug is Hycodan?
Schedule II
What schedule drug is Hydrocodone/ibuprofen (Vicoprofen)?
Schedule II
What schedule drug is MS Contin?
Schedule II
What schedule drug is Oxycontin?
Schedule II
What schedule drug is Tussionex?
Schedule II
What schedule drug is amobarbital?
Schedule II
What schedule drug is amphetamines (Dexedrine, Adderall)
Schedule II
What schedule drug is cocaine?
Schedule II
What schedule drug is codeine (by itself)?
Schedule II
What schedule drug is diphenoxylate?
Schedule II
What schedule drug is fentanyl (Duragesic, Actiq, Fentora, Lazanda)?
Schedule II
What schedule drug is hydrocodone/APAP (Vicodin, Lorcet)?
Schedule II
What schedule drug is hydromorphone (Dilaudid)?
Schedule II
What schedule drug is meperidine (Demerol)?
Schedule II
when was the Final Rule for Disposal of CS published? When was it implemented?
September 8, 2014; October 9, 2014
If partially filling CII script, what needs to be done?
note amount dispensed on the face of the prescription
Hospital regulations for pharmacy services are located where?
Title 28, Chapter 113
What is the REMS program for Tracleer (bosentan) called?
Tracleer Access Program (TAP)
If a practitioner writes a script for GHB, they must do what?
note the medical need of the prescription for the patient
Compounding needs to be done in compliance with what?
USP chapters on compounding, using substances that comply with monograph standards
In contrast with traditional compunding pharmacies, large batch sterile compounders must follow what rules?
Under DQSA should become outsourcing facilities and are under more FDA scrutiny to allow for hospital pharmacies and doctors offices to legally buy sterile compounded products from outsourcing facilities
Pharmacy may use what to keep track of telephone prescriptions, refills, counseling, etc?
computerized recordkeeping system
Are electronic prescriptions allowed to be written for CIIs?
YES
Are faxed CIII-CV scripts (and non-controls) allowed to serve as original prescriptions?
YES
Can CII scripts be faxed?
YES
Can CII scripts be partially filled?
YES
Can refill information for CS be stored centrally?
YES
Does iPLEDGE system still have to be used for male patients?
YES
Does the age requirement for purchasing plan B apply to males as well?
YES
If CSA Notice of Inspection is issued can the pharmacy owner refuse?
YES
If pharmacy has retail pharmacy operating out of it, do they need a separate DEA registration for CS activity for this pharmacy?
YES
Are veterinarians allowed to prescribe CS to animals?
YES as long as in good faith in the course of his/her professional practice and not for use by human being
Is faxing of CII scripts allowed?
YES, but generally before dispensing a faxed CII order pharmacist must receive the original signed Rx for review
Do practitioners need to be registered individually with the DEA to prescribe controlled substances? Exception?
YES; but if individual practitioner is agent or employee of hospital or other institution the practitioner may, while in the normal course of business administer, dispense, and prescribe controlled substances under the registration of the hospital or institution
Can FDA require drug device recalls?
YES; can require manufacturer to recall
Can a brick and mortar pharmacy still have website and not be considered online pharmacy?
YES; if only do refills of CIII-V or request and fill new CIII-CV if patient has previously had CIII-CV filled
Is it legal for a practitioner to write a script for a drug for an off-label use and for a pharmacist to fill it?
YES; just must use professional judgement (manufacturer may distribute peer reviewed literature that describes off label use)
Is PA law in agreement with USP guidelines on beyond use date for multiple use containers?
YES; use manufacturers expiration date if it is less than 1 year, otherwise use 1 year
Does DEA permit centrally filling of CS?
Yes if certain requirements are met
Are drugs/devices that are prone to degradation from heat, cold fermentation, or prolonged agitation allowed to be mailed?
Yes if shipped in a manner which would preserve the integrity of the drug
Can any DEA CS registration be transferred?
Yes, but need DEA's approval after submitting written request (don't confuse with transfer of business if pharmacy goes out of business)
Are cancer drugs allowed to be distributed to other health care providers? If so, who?
Yes; can distribute to physicians office, pharmacy, hospital, health care facility, or health clinic for dispensing by pharmacist as allowed by federal or state law
Can pharmacist refuse inspection or withdraw consent during an inspection if only a Notice of Inspection is served?
Yes; only search warrant or AIW can't be refused
Are LTCF residents allowed to purchase medications from pharmacy of choice?
Yes; resident must be notified at admission and through stay of right to use pharmacy of choice and of responsibility to comply with facility's policies and state and federal law regarding packaging and labeling
Prior to performing any services in connection with AMS, pharmacy manager must ensure what?
all licensed practitioners and supportive personnel are trained in pharmacy's SOP in regard to AMS as set forth in the written policies and procedures; training needs to be documented and available for inspection
Under medicare, who is responsible for developing, supervising, and coordinating all the activities of pharmacy services?
a full time, part time, or consulting pharmacist
What is an example of an exception where two different activities do not need to be registered separately for CS activity?
a manufacturer doesn't need to register as a distributor to distribute their product to a wholesaler
Under medicare, all compounding, packaging, and dispensing of drugs and biologicals in the hospital setting must be under the supervision of who? All of this must be performed according to what?
a pharmacist; state and federal laws
OTC drug monographs can be like what? In what way?
a recipe; manufacturer adheres to the acceptable ingredients, doses, formulations, and labeling in the OTC monograph
By 11/2023 what is required in terms of track and trace under PDMA?
all partnerns (mfg, wholesaler, repackager) required to electronically track and trace all products using standardized numerical identification (SNI) NDC + 20 digit serial number
How are devices classified?
according to function, premarket approval of certain devices, performance standards, conformance with cGMP regulations, and adherence to record/reporting requirements
The AMS must electronically record what?
acitivity of each pharmacist, tech, or other authorized personnel with the time, date, and initials or other identifier so that a clear, readily retrievable audit trail is established
What is the definition of health care operations under HIPAA?
activities required for the day to day operations of the pharmacy, including record keeping, preparation, and review of quality assurance reports and risk management activities, etc.
Generally, separate registration is needed for each CS __________
activity (i.e. manufacturing, dispensing, etc.)
Clinical considerations section in pregnancy/lactation provides what?
addresses situations in which a woman was inadvertently exposed to the drug, any effects of the medication will have in labor and delivery, and decisions that clinicians may have to make while prescribing these meds to pregnant women including dosing adjustments, adverse reactions, interventions required
If strength, quality, or purity of a drug is affected it may be considered what?
adulteration AND misbranding
What are the two major violations of the FD&C Act recognized by the FDA?
adulteration and misbranding
it is unlawful for nonresident pharmacy that has not been issued a registration to do what?
advertise its services in PA or for person who is resident of commonwealth to advertise on behalf of the nonresident pharmacy that doesn't have registration from board with the knowledge that the advertisement will or is likely to induce members of the public to use the non-resident pharmacy
Drugs and biologicals not specifically prescribed as to time or number of doses must be stopped when?
after a reasonable time that is predetermined by the medical staff
If license suspended under felony conviction with CSDDCA, when can it be reinstated?
after at least 10 years from date of conviction or board may reinstate if they are satisfied the person has made significant progress in personal rehabilitation, if reinstatement would not cause substantial risk of harm to others or public, and if person meets all other licensing qualifications of pharmacy act
Clozapine poses high risk of what?
agranulocytosis
All patients on thalidomide must do what?
agree to complete a confidential survey about their compliance with contraception, testing, and drug therapy
Which products need to have tamper evident packaging?
all OTC human drug products and cosmetic liquid oral hygiene products, vaginal products, and contact lens solutions and tablets
Data section in pregnancy/lactation provides what?
all available data for the medication and it's use in pregnant women (human data takes precedence over animal data) - includes type of study, which animals used, dosage, types of adverse events, and relationship between drugs exposure in animals vs humans
What is the definition of payment for HIPAA purposes?
all communications required to obtain payment or reimbursement for the dispensing activities, including obtaining prior authorization from third party payers, claims submissions, and providing information to payers concerning the patient's diagnosis and the use of the drug or the need for drug therapy
Before granting pharmacy authorization to fill and dispense isotretinoin what does the iPLEDGE system check?
all criteria are met by prescriber, patient, and pharmacy
What locations does USP <800> cover?
all healthcare entities that store, prepare, transport, or administer hazardous drugs (including pharmacies, hospitals, other healthcare institutions, patient treatment clinics, physicians practice facilities, and vet offices)
Who does USP <800> apply to?
all healthcare personnel who handle hazardous preparations (pharmacists, pharmacy techs, nurses, physicians, PAs, home healthcare workers, veterinarians, and et techs)
How often does training need to be updated for sale of SLCP?
annually
Manufacturers and distributors must register how often for CS activity?
annually
If pharmacy uses AMS, how often to policies and procedures for this need to be reviewed?
annually at least
Under standing order, who is allowed to dispense/prescribe naloxone? what forms? to who?
any authorized medical professional; intranasal, auto injector, nasal spray; to any one at risk of opioid related overdose, family members, friends or any other person who may be in a position to assist such a person
Any person or facility who reports suspection of addiction or diversion by a professional shall be exempt from what?
any civil or criminal liability arising from such report
What is under Section 503B in FDCA
any compounder who compounds sterile products can become an outsourcing facility which will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use
What is a hazardous drug?
any drug identified as hazardous or potentially hazardous by the National Institute for Occupational Safety and Health (NIOSH) on the basis of carcinogenicity, teratogenicity, developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity
Pharmacist may not provide what to physician for the purpose of entering into a collaborative agreement?
any economic incentives
Pharmacist or pharmacy may not in any way provide what to prescriber for purpose of transmitting prescriptions?
any electronic equipment
Who would be considered a business associate of a covered entity under HIPAA?
any entity that creates, receives, maintains, or transmits PHI (like billing services, prescription software vendors, data archive companies, and companies that destroy labeled prescription vials)
How is dietary supplement defined under FD&C Act?
any product that is intended for ingestion, intended to supplement the diet and that contains vitamins, minerals, herbs or other botanicals, amino acids, concentrate, metabolite, constitutent, extract, or combination of the above; or dietary substance for use by man to supplement the diet by increasing the dietary intake
Impairment program does not apply to who?
any professional convicted of, pleaded guilty to, or entered a plea of nolo contendere to a felonious act prohibited by the CSDDCA or the conviction of a felony relating to a CS in another jurisdiction
What precautions may retailers take to guard against employing individuals who may present a risk with respect to the theft and diversion of SLCP products?
any reasonable measures including asking job applicants whether they have been convicted of any crime involving or related to SLCP products or CS
Who may order on the DEA CSOS?
any registrant permitted to order schedule II controlled substances
Once Board is notified of a new pharmacy manager, how is approval from board made?
approval is assumed if the Board doesn't notify the permit holder within 30 days
To receive donations from cancer drug repository program, pharmacy must designate what?
area within pharmacy for donations
Can prescription vials be re-used? Why?
as a general rule no because the wear on a plastic vial could compromise the effectiveness specifications
Pharmacies electronically sharing a real time, online database may transfer CS prescriptions how many time?
as many times as needed up to the maximum refills allowed by law
If computer is down and information from prescriptions cannot be entered in, it must be entered into computerized record keeping system when?
as soon as it is available for use
In the event a patient experiences an adverse event or reaction under order or protocol, pharmacist must notify physician when?
as soon as practicable and in NO EVENT later than 24 hours after learning of the adverse event or reaction
Notification to the authorizing physician of changes in dose, duration, or frequency of medication prescribed in non-institutional setting must be in what time frame?
as soon as practicable but no later than 72 hours after change
documentation of pharmacist interventions during non-institutional MTM must occur when?
as soon as practicable, but no later than 72 hours after the intervention
When administration of injectable occurs under written protocol, pharmacist shall notify physician when? Notify PCP in what time frame?
as soon as practicable, but no longer than 72 hours after administation; notify PCP within 48 hours
When administration of injectable occurs under an order, pharmacist needs to notify prescriber within what time frame?
as soon as practicable, but no longer than 72 hours after administration
What does the P&T committee do (broadly)?
assist in formulation of broad professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use and safety procedures relating to the use of drugs in the hospital
MTM agreement may be terminated when? By who?
at any time at the request of any party to it
What can reverse distributor do?
at any time return CS to manufacturer or dispose of them
A hard copy of a prescription that is transmitted electronically needs to be stored how long?
at least 2 years from date of most recent filling
Meds in AMS should be inspected how often? For what?
at least monthly for expiration date, misbranding, physical integrity
AMS itself should be inspected how often? For what?
at least monthly for security and accountability
Under medicare requirements how often must drug regimen of each resident in a LTCF be reviewed by a pharmacist? What must the pharmacist do as part of this?
at least once a month; need to report any irregularities to the attending physician and the director of nursing and these reports must be acted upon
How often does P&T committee need to meet? What should be done at these meetings?
at least quarterly; record its proceedings and report to the medical staff
If barcode is required for a drug product must contain what?
at minimum the NDC number in a linear bar code which must be included on the drug label
When must NOPP be provided to all patients?
at the time that the pharmacy service is first provided to the patient
Once hard copy of emergency CII script obtained, pharmacist needs to do what with it?
attach it to the oral emergency written prescription that has been reduced to writing
Medications in LTCF need to be administered under written orders of who?
attending physician
Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to who?
attending physician and if appropriate to the hospital wide quality assurance program
What is clozapine?
atypical antipsychotic used to treat schizophrenia
ABC-MAP is operated under who?
auspices of the PA Dept of Health
Any renumeration from a drug company beyond the cost of providing refill reminders would require what?
authorization for release of PHI
Who may have access to locked areas in hospital pharmacy where CS are stored?
authorized personnel
Medications shall be administered to LTCF patient by who?
authorized personnel including doctor, dentist, RN, LPN, CRNP, PA, etc.
Prescription sent electronically must have what protection?
be electronically encrypted or transmitted by other technological means designed to protect and prevent access, alteration, manipulation, or use by any unauthorized person
Inventory must be taken at what time of the day?
beginning or close of business and the time must be recorded in the inventory record
Where do all SLCP products need to be placed?
behind a counter that is not accessible to purchasing consumers or in a locked display case that is located on the selling floor
Again, treatment with CIII-CV written by optometrist may not last longer than what?
beyond 6 weeks, unless the prescribing optometrist documents consultation with licensed physician
What is the inventory requirement for controlled substances?
biennial (every 2 years); must be within that two year period
Recommendation from the Secretary of Dept of HHS is ______________ on the Attorney General
binding
Practitioners wishing to prescribe and dispense methadone in an OPIATE treatment program (OTP, new one) must have what?
both registration from DEA as narcotic treatment program and certification from CSAT and the applicable state authority
Not only are covered entities responsible for PHI violations, who may also be subject to the rules of PHI?
business associates of covered entities
licensee engaging in MTM under protocol must certify compliance with liability insurance requirement how?
by completing from Board and upon request provide the Board a certificate of insurance regarding the licensee's maintenance of professional liability insurance
Initial written orders and countersignature for LTCF may be received how?
by fax which includes the practitioner's signature
Cancer drugs shall only be dispensed by who? Pursuant to what?
by licensed pharmacist pursuant to prescription issued by prescribing practitioner
How does one need to certify compliance of liability insurance for collaborative agreement?
certify on form available from board of pharmacy and submit the form along with the collaborative agreement and upon request make certificate of insurance available to the board regarding the the licensees maintenance of professional liability insurance
Inventory must also be taken of controlled substances when?
change in ownership
If pharmacist dispenses drug that has been recalled, what can happen?
charged with violation of the Food Drug and Cosmetic Act
If substituting less expensive interchangeable biological, need to ensure that what?
charging regular and customary retail price for the interchangeable product; and recording the substitution
What is the only way to know for sure if a DEA number is genuine?
check DEA database
If pharmacist receives paper copy of a script that indicates it was previously sent electronically, the pharmacist must do what?
check records to ensure the electronic version was not received and the prescription dispensed; if both received, need to mark one as void
If pharmacist receives paper prescription that indicates electronic script was previously sent to different pharmacy, what should pharmacist do?
check with that pharmacy to determine whether prescription was received and dispensed - if not then other pharmacy must mark electronic copy void - if was filled, then pharmacist should make paper copy void and not dispense
If non compliant with HIPAA federal government is permitted to impose both _______ and ___________ penalties
civil and criminal
Besides criminal penalties, board may also (by majority vote) levy what penalty? For what? This can only be levied when?
civil penalty of up to $1000 on any licensee who violates any provision of pharmacy act who practices without being properly licensed to do so; can only be levied after opportunity for a hearing
MTM requirements in non-institutional setting are similar to institutional, but instead of protocol, MTM in non-instutional setting is pursuant to what?
collaborative agreement
CRNP ability to prescribe is based on what?
collaborative agreement between CRNP and physician
Midwife prescribing is based on what?
collaborative agreement with a physician
Pharmacies may only participate in what kind of CS disposal programs?
collection receptacles
Pharmacy needs to be classified as what to perform on site destruction of CS?
collector (and be DEA registered)
Advertising shall be done for a _________________ __________________ ____________
commercially reasonable quantity
Electronic transmission of a prescription means what?
communication of original prescription or refill authorization by electronic means to include computer to computer, computer to fax, or email transmission
If there was a confirmed theft or loss of CS, pharmacist should do what?
complete DEA form 106 related to the theft or loss
Inventory must contain what?
complete and accurate count of all controlled substances "on hand" (i.e. in the possession of or under the control of the registrant
Education requirements for authorization to administer injectables need to be administered in what time frame and using what?
complete within 2 years prior to application; complete using an evidence-based course
For pharmacists just initially getting their license, what is the requirement for opioid related CE?
compliance within 12 months of obtaining a license by completing 2 hours of education in pain management or ID of addition and 2 hours in prescribing or dispensing of opioids (this requirement may be part of the professional degree education)
If pharmacist has license suspended or revoked, need to still do what if they want to have their license reinstated?
comply with CE requirements during period of suspension or revocation
What is the exception to the red C rule if filing controlled scripts? Does PA law follow this?
federal law says can go without red C if pharmacy employs a computer system for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled - YES PA law follows for electronic CS scripts, but silent on paper prescriptions
What must prescriber enter into the iPLEDGE program each month?
female patient's pregnancy results and the 2 forms of contraception she has been using
What is Onsolis?
fentanyl buccal soluble film
What is Fentora?
fentanyl citrate buccal tablets
What is Actiq?
fentanyl citrate oral transmucosal lozenge and generic equivalents
What is Lazanda?
fentanyl nasal spray
What is Subsys?
fentanyl sublingual spray
What is Abstral?
fentanyl sublingual tablets
Mailing of prescriptions is permitted how?
first class or common carrier unless patient agrees to slower means
What is the second letter in a DEA number?
first letter of physician's last name
One can apply for a a pharmacy internship when?
following completion of at least 2 years of college and if enrolled or accepted as a student of pharmacy in an ACPE accredited pharmacy degree program
The offer to counsel shall be made to each patient when?
for each NEW retail or outpatient prescription
Pharmacist requirements, drug regimen reviews, labeling of drugs and biologics, and storage of drugs and biologicals are all requirements for what?
for medicare to participate
Standing order for naloxone strongly encourages what?
for those obtaining naloxone to complete a training program and provide link to approved program
In order for foreign college grad to show knowledge of American Pharmacy and the ability to communicate in engihs they must have what?
foreign pharmacy graduate examination committee certification (FPGEC)
A _____________ ___________ must be establised by the medical staff to assure quality pharmaceuticals at reasonable costs
formulary system2
For each electronic order on DEA CSOS filled, supplier must forward copy to who, and in what time frame?
forward copy of electronic order or an electronic report of the order in a format that DEA specifies to DEA within 2 business days
In 2009 the age for purchasing Plan B changed to what?
from 18 to 17
In PA what is a distinction to keep in mind in regards to substitution of therapeutically equivalent drugs?
generally follows rules of orange book; BUT if drug is A rated it cannot be substituted if it has a narrow therapeutic range since the law states that narrow therapeutic range drugs are not considered generically equivalent
Under Waxman Hatch what was not required for generic drug approval? What does generic manufacturer have to do?
generic manufacturer was not required to prove safety and efficacy of the drug through clinical studies, but only had to show the drug was bioavailable and bioequivalent to innovator drug
Pharmacy is required to make a _________ ___________ effort to obtain a patient's written acknoledgement of receipt of NOPP
good faith
FDA Amendments Act signed into law in 2007 did what?
granted FDA broad new authority related to safety of new and already approved drugs including power to require REMS programs
If pharmacist wishes to dispense/order clozaril, what must they do?
have facility/store registered with clozaril national registry in order to purchase Clozaril from a wholesaler
All schedule V quantity limitations come with what stipulation?
have to be with one or more active non narcotic active medicinal ingredients in sufficient portion to confer upon the mixture or compound valuable medicinal qualities other than possessed by the narcotic alone
What is the rule under HIPAA?
have to keep a patient's health care information confidential
How is tamper evident packaging defined?
having one or more indicators or barriers to entry, which if breached or missing, can reasonably be expected to provide visible evidence that tampering has occurred
If compounders register with the FDA as outsourcing facilities, hospitals and other health care providers can do what with the outsourcing facility?
hospitals and other health care providers can provide their patients with drugs that were compounded in outsourcing facilities that are subject to CGMP requirements and federal oversight
What is the isotretinoin REMS computer program?
iPLEDGE
For prescription refills, need to make sure that refills are dispensed with __________ ____________ unless what?
identical product (to first fills; same distributor and manufacturer); unless person presenting script and practitioner authorize in advance a different manufacturers generic equivalent product
What needs to be done with outdated, deteriorated, or recalled medications in LTCF?
identify and return to dispensing pharmacy for disposal at least quarterly and document disposition
Again, Red C does not need to be used if what method of filing is used?
if CIII-CV scripts are not comingled with other scripts (i.e. if they are filed separately)
When may testing on human begins after IND is submitted?
if FDA doesn't reject IND in 30 days then clinical testing on humans may begin
When would treatment related communications that aren't usually considered marketing be considered marketing?
if any financial renumeration occurs
Unit dose test failure occurs if what?
if child can access more than 8 individual doses or a toxic amount, whichever is less
Physician can delegate prescribing, dispensing, and administration of drugs and therapeutic devices to the physician assistant if what?
if drug/device is permitted under the written agreement
In PA, pharmacy would be required to be licensed as a wholesaler if what?
if sales to licensed practitioners exceeded 5% of the retail pharmacy's total annual prescription drug sales
Audit report on pharmacy application for electronic prescribing of Controlled substances will indicate what?
if the application is capable of importing, displaying, and storing DEA required prescription information accurately and consistently
Re-use of prescription vials may be allowed if what? Why?
if the container is glass due to negligible wear/damage and provided a new child-resistant closure is used (this also can apply to any other package type that is not prone to wear)
Criminal sanctions can be imposed for HIPAAA if what occurs?
if the disclosure was done intentionally or with knowledge that the information was protected, but was nevertheless disclosed.
When is the only time medications that were picked up can be returned to stock?
if the drug is in the original sealed container with the name, lot number, and expiration date on the original intact manufacturers label
Pharmacist may only accept electronically transmitted prescription if what requirements are met?
if the prescription includes - information required under state and federal law - prescriber's telephone number - date of transmission - name of pharmacy intended to receive the transmission - signature or the electronic equivalent of a signature of the prescriber
If pharmacist is licensed in multiple states/territories board will also notify these other states/territories if what?
if there is disciplinary actions taken against the pharmacist in PA
When are OTC drugs exempt from expiration dating?
if they are stable for at least 3 years and their labeling does not bear dosage limitations
If prescription order is given verbally, how is it distinguished if prescriber wants brand name medication dispensed?
if they don't expressly say dispense brand, then dispense generic
Previously breaches only needed to be reported if what?
if they posed risk of financial, reputational, or other harm to the affected individuals
If emergency CII script, the script be reduced to writing within what time frame?
immediately
Person receiving order from prescriber in LTCF needs to do what after receiving order?
immediately record the order in the patient's clinical record and sign and date the entry
If any used or unused DEA 222 order form is lost or stolen (other than in the course of transit) what should be done?
immediately upon discovery of theft or loss report the same day to the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located, stating the serial number of each form stolen or lost
Act 95 also grants what kind of immunity?
immunity from civil liability for pharmacists or prescribers for dispensing interchangeable biological product unless it was incorrectly substituted
Adulteration act also prohibits what?
interstate commerce of drugs and devices with impurities, poisons, and decomposed ingredients
What was the NECC compounding disaster?
in 2012 massachusetts pharmacy, North East Compounding Center (NECC) compounded and shipped large batches of contaminated sterile injectables to hospital pharmacies, doctors offices, and other entities which killed 64 individuals and injured more than 700 others
Prescriptions for CIII-CV substances shall be maintained how?
in a separate file or in such form that they are readily retrievable from other prescriptions in the pharmacy
Prescriptions for CII substances shall be maintained where?
in a separate prescription file
For medicare to participate drugs and biologics used in a LTCF must be labeled how?
in accordance with currently accepted professional principles and include appropriate accessory and cautionary instructions and expiration date
If use different distributor/manufacturer drug to fill refill medication and it is not identical to first fill, when does prescriber need to be notified?
in advance, but if not possible to do in advance then do ASAP thereafter
If doing mail order and pharmacist substitutes generic drug for brand name, how is communication made?
in communications to mail order customer should include statement saying "PA LAW PERMITS PHARMACISTS TO SUBSTITUTE LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG OR AN INTERCHANGEABLE BIOLOGICAL PRODUCT FOR A BRAND NAME DRUG UNLESS YOU OR YOUR PHYSICIAN DIRECT OTHERWISE. CHECK HERE IF YOU DO NOT WISH A LESS EXPENSIVE BRAND OR GENERIC DRUG PRODUCT"
For medicare to participate, how do drugs and biologics need to be stored in LTCF?
in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys
drug may be eligible for donation if it comes how?
in original unopened, sealed, tamper evident unit dose packaging or the drug is packaged in single unit doses when the outside packaging is opened, but the single unit dose packaging is unopened
Documentation of completion of maintenance on AMS should be kept on file where and how long?
in pharmacy for at least 2 years
Pharmacy may not contribute in any way to the installation of a fax machine where?
in prescriber office or institution
Where do drugs and biologicals need to be kept in hospital setting (under medicare)? Where do CS need to be stored?
in secure area and locked when appropriate; CS need to be locked within secure areas
For medicare to participate, how must CS be stored in LTCF?
in separately locked, permanently affixed compartments for storage of controlled drugs listed in schedule II and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected
The only setting where tax free alcohol can be used is where?
in the hospital setting; may not be used in retail setting
Records for drugs dispensed from the pharmacy should be maintained where?
in the pharmacy
Copy of written policies and procedures on AMS needs to be kept where?
in the pharmacy and at the long term care facility where the automated medication system is utilized
Syringes and needles for sale must be kept where?
in the prescription area
If pharmacy manager is lost, must notify Board how and in what time frame?
in writing with name f new pharmacist manager within 15 days
Personal Address change form on board website requires what?
include both old address and new address, license number, SSN, date of birth
If more than two pharmacists are on duty at one time then what are the requirements for counter length?
increase by 5 linear feet for an additional pharmacist (ie 15 feet for 3 pharmacists, 20 feet for 4 pharmacists)
Prior to dispensing donated cancer drug, need to do what?
inform the patient that the drug was previously dispensed, but was unused and then donated in original, unopened, sealed, and tamper evident unit dose packaging to be restocked and redistributed
All professional staff in hospital setting must have access to what?
information related to drug interactions, drug therapy, side effects, toxicology, dosage, indications, and routes of administration
Before patients can begin in investigational drug trials they need to sign what?
informed consent
If using a manual system, pharmacist must record what when refilling CIII-CV presciptions?
initial and date the back of the prescription for each refill
Before a pharmacy commences business an _____________ _________________ must be taken
initial inventory (even if it is zero)
If a pharmacist objects to dispensing certain medications they cannot do what?
interfere with another pharmacist responding to the needs of a patient, or engage in any judgmental or confrontational behavior with the patient
If issuing multiple CII prescriptions at once they must be issued for a _____________ ______________ ________________ by a individual practitioner acting in the course of ______________ ____________
legitimate medical purpose; professional practice
Prescription for CS must be issued for ___________ _____________ ________________ by a practitioner acting in ______________ ______________ __ __________ __________________ ______________
legitimate medical purpose; usual course of higher professional practice
If a graduate of a foreign college has experience in pharmacy practice and can demonstrate knowledge of American pharmacy and proficient in communcation of English language, board may approve what for internship?
less than 1500 hours, but no less than 500 hours
Therapeutically Ceritifed Optometrists will have what in license number?
letter "T"
What medication is in emergency contraception (Plan B/generics)?
levonorgestrel
When there is a pharmacy in institution, who directs the pharmacy? If no pharmacy, what happens?
licensed pharmacist; if no pharmacy or full-time pharmacist then part time pharmacist shall have responsibility for control and dispensing of drugs shall have responsibility for pharmaceutical functions of nursing stations
Access to AMS for stocking and removal of medications should be limited to who?
licensed pharmacists or the pharmacist's designee acting under the supervision of the licensed pharmacist
Pharmacist needs to enter into collaborative agreement with who in order to do MTM?
licensed physician who authorizes the management of drug therapy for a disease or for condition or symptom of a disease
Protocol for MTM needs to be signed by who?
licensed physicians and pharmacists who are entering into the protocol and the dates signed
Access to records of medications and other medical information of patients maintained by pharmacy (subsequently used in AMS) is limited to who?
licensed practitioners or personnel approved to have access to the records
Schedule IV drugs have what physical and psychological dependence?
limited physical dependence, limited psychological dependence
Physicians prescribing buprenorphine are initially limited how? When are these limitations lifted (and what are the new regulations)?
limited to 30 patients initially; can request to treat up to 100 patients after 1 year; and new regs say if physician has prescribed buprenorphine to 100 patients for at least 1 year they can now apply to increase their patient limits to 275
In the absence of pharmacist, dispensing of drugs in an institution is limited to what?
limited to emergencies and shall be performed only under the direct supervision of a practitioner licensed under the state to prescribe and dispense drugs
In addition to notification that generic substitution is allowed, also need to post what outside pharmacy?
list of commonly used generically equivalent drugs and interchangeable biological products containing brand names, list of manufacturers, and generic names, alphabetized and in boldface type
What should be listed on the DEA form 41?
list the controlled substance or substances which the registrant desires to dispose
How can pharmacies limit who has access to PHI?
locked prescription files, shredding paper PHI records that are being discarded
If license, certificate, or registration has been suspended or revoked due to felony conviction under CSDDCA, what may happen?
loss of license for mandatory 10 years
Schedule V drugs have what physical and psychological dependence?
low physical, limited psychological
Waxman Hatch Amendment did what?
made it easier for generic drugs to get FDA approval
What are the options for disposal programs allowed under the Final Rule on CS?
mail back, collection receptacles, collection events
Again, who submits IND?
manufacturer
Prior to Durham Humphrey who determined if drug was prescription or OTC?
manufacturer
*Online pharmacies* have to report what to the DEA and how often?
monthly report of quantity of each CS dispensed and NDC if during the month in question the pharmacy has dispensed at least 100 prescriptions or at least 5000 dosage units
All permit applicants must be of good _______ and _______________ _________________
moral and professional character
Dibucaine OTC must be in CRC if what amount?
more than 0.5 mg in a single package
What is central filling?
more than one pharmacy fills a prescription; i.e. pharmacy #1 receives a script and then forwards it to central fill pharmacy (pharmacy #2) which fills the script and then returns it to the pharmacy that originally accepted the prescription (pharmacy #1)
In general what prescriptions are required to be dispensed in CRC?
most prescription medications
All schedule III quantity limitations also come with what stipulation?
must also be with one or more active, non-narcotic ingredients in recognized therapeutic amounts
Within a prescription area, what are the requirements for prescription counter?
must be at least 10 linear feet in length and 2 linear feet in width
What is the requirement for obtaining pharmacy permit if the applicant (individual or partnership) is a pharmacist?
must be licensed by the Board
If pharmacist fails to renew license in time, what must happen?
must cease practice until renewal is obtained
Under collaborative agreement, what is the requirement for liability coverage?
must have coverage in minimum amount of $1,000,000 per occurrence or claims made
Women of childbearing potential must undergo what before using thalidomide? What must they use?
must have pregnancy testing done prior and on a regular schedule during therapy and must use contraception (including emergency contraception)
If third party auditor finds that pharmacy application does not accurately and consistently import, store, and display other information required for prescriptions, the pharmacy must not do what?
must not accept electronic prescriptions that only include subset of the information (i.e. if only hospital DEA on script, application needs to be able to import, store, and display hospital DEA and individual practitioners DEA extension) *pharmacy can continue to process other controlled prescriptions if pharmacy application meets all other requirements*
If med guide is required, what must authorized dispenser of a drug do?
must provide the Med guide directly to each patient or each patient's agent when the product is dispensed, unless an exemption applies
Pharmacies must submit what to PDMP if they did not dispense any CS on a given business days? What is the exception?
must submit zero-report; can request waiver from submitting zero reports if the pharmacy never dispenses CS or dispenses less than 5 CS per month
Each month a patient is on isotretinoin they must have what type of pregnancy testing done?
must test negative on urine or blood test conducted by CLIA certified laboratory prior to receiving the prescription
If patient presents with new script for clozaril (and is new to the pharmacy), what must the pharmacist do?
must verify the patietn is eligible and registered with CNR before dispensing
What must patient package insert contain?
name of the drug, summary of effectiveness, contraindications, risks and benefits, etc.
All pharmacists renewing license after January 1, 2015 need to have what specific CE requirement under Act 31?
need 2 hours of board approved CE in child abuse recognition and reporting
What should happen with discontinued or unused medications of discharged or deceased residents?
need to be handled by facility policy which should be developed in cooperation with consultant pharmacist, method of disposition and quantity should be documented in respective resident's chart; disposition procedures shall be done at least quarterly
What are the requirements for personnel who will be selling SLCP?
need to be trained by retailer and understand the requirements and submit self certifications to the Attorney General; retailer needs to maintain certifications/records
Expedited approval of investigational drugs by FDA is conditional on what?
need to complete Phase IV post marketing studies
Any applicant that intends to take the NAPLEX and MPJE needs to complete what? Also needs to provide what as part of this?
need to complete application and provide proof of graduation with BS or advanced degree in pharmacy from ACPE accredited school or college and affidavits of internship (proper hours)
If a pharmacy is staffed by only one licensed pharmacist and the pharmacist has objections to dispensing certain medications what needs to happen?
need to ensure protocols are in place to avoid harm to patient
What is the usual and customary pricing signage requirement?
need to have available a list of usual and customary retail prices of that pharmacy for brand name and generic equivalent drug products and interchangeable biological products with the name of the manufacturer, available for selection by the person presenting the prescription
Reciprocally licensed pharmacists need to start accumulating contact hours when? How many?
need to start at the beginning of the next quarter following licensure and will be required to earn 3.75 contact hours each quarter thereafter until the end of the licensure period
iPLEDGE designed to create link between what?
negative pregnancy test and the dispensing of the prescription for the female patient of childbearing potential
Med guides are applicable to both ____ and ____________ prescriptions
new and refill
Personal Name change form on board website requires what?
new name, former name, and official documentation that legalized the name change (like marriage license, or court document), license number, SSN, date of birth
In May 2001, what happened with the Narcotic Addict Treatment Act (what regulations were changed)?
new regulation repealed FDA regulations - transferred enforcement to Center for Substance Abuse Treatment (CSAT) within the Substance Abuse and Mental Health Services Administration (SAMHSA) - changed the name of the treatment programs from narcotic to opioid treatment programs (OTPs)
Is name of collaborating physician required on a prescription from nurse midwife?
no
What absolutely has to be discussed during counseling?
no absolute guidelines; it is at discretion of the pharmacist
Do manufacturers need to get FDA pre-approval to make drug if a drug monograph is available?
no as long as they simply follow the "recipe"
Are there specific timelines required to notify board if change in name or email (personal)??
no but should be reported promptly
Are refill reminders considered marketing?
no if financial renumeration received is reasonably related to costs of making a refill reminder
What are the USP guidelines on beyond use dates for multiple unit containers (typical prescription vial)?
no later than the expiration date on the manufacturers container or one year from the date the drug is dispensed, whichever is earlier
If pharmacist is changing dosing, duration, or frequency of medication prescribed during drug therapy management, how soon does physician need to be notified?
no longer than 72 hours after the change
Registrant can renew CS registration application when? WHat form needs to be completed?
no more than 60 days prior to current expiration date; complete DEA 224a appication
What are the mail order limits on SLCPs? Mail order sales are also not subject to what?
no more than 7.5 grams within a 30 day period; not subject to logbook, training, or certification requirements (only have to request identification)
What is the 30 day purchase limit on SLCPs?
no more than 9 grams in 30 day period
IF DEA CSOS order is defective can it be corrected?
no neither purchase or supplier can correct, will need to issue new order to be filled
If you are newly licensed pharmacist do you have to meet CE credits right away?
no, exempt from completing CE hours for the license renewal immediately following licensure
Is it mandatory to use 222 forms in sequential order?
no; but makes sense to do so considering reporting requirements for lost/stolen forms
If pharmacists have access to the same database, what are teh recording requirements?
none provided that both pharmacists have access to the same computerized prescription system which contains the prescription and refill records and incorporate procedures to prevent unauthorized refills
Treatment initiated by a therapeutically certified optometrist may continue how long?
not beyond 6 weeks unless consultation with a licensed physician
What are the exceptions for marketing under HIPAA?
not considered marketing if it is for the treatment of the individual, face to face communications, for case management or care coordination, direction or recommendation on alternative treatments, therapies, health care providers, or settings of care, health related services offered by pharmacy or health plan
Are interns currently allowed to administer injectables under supervision of a pharmacist?
not currently, but regulations are being developed
Pharmacist may enter into written protocol with physician or medical staff to administer injectables for period of how long?
not to exceed 2 years
Written protocol for MTM must be effective for what time period?
not to exceed 2 years from the date of execution
Handling fee may be charged for drugs in cancer repository program, but what are the limits on the handling fee?
not to exceed 250% of the Medical Assistance dispensing fee
Can pharmacist manager serve as manager for more than one pharmacy?
not usually, but can make a request in writing that the Board waive the rule
If pharmacist substitutes less expensive generic for brand name drug, need to do what?
notify the patient or person presenting the prescription or have intern or other person under supervision of pharmacist do it (just need to notify them that generic substitution is possible, advise on price, and informing that they may refuse the substitution either orally or in written statement
If a pharmacist has objections to dispensing a medication due to his/her beliefs or beliefs will limit drugs dispensed what should they do? What should be done then?
notify the pharmacist manager at the beginning of practice; owner and pharmacist manager should devise reasonable accomodations that will respect the pharmacist's wishes while assuring the delivery of services to patients in need (i.e. have another pharmacist on duty or a collaborative agreement with a neighboring pharmacy)
Supplier may void part or all of an order on a DEA 222 form how?
notify the purchaser in writing, indicate the voiding on copies 1 and 2 by drawing a line through the cancelled items and printing void in the space provided for the number of items shipped
How can a purchaser cancel part of a 222 order?
notify the supplier in writing; supplier can then indicate the cancellation on copies 1 and 2 by drawing a line and marking the item cancelled
Pharmacist may allow license to lapse by doing what?
notifying the board via the renewal form and surrendering pocket license and display license
It is very important that the purchaser record what on copy 3 of the DEA 222 form?
number of containers received and the date received
Seller of dietary supplements must have substantiation that what?
nutritional support statements are truthful and not misleading
Long term care facilities may also dispose of CS how?
on behalf of ultimate user residing in or previously residing at the facility in the collection receptacle maintained by the hospital, clinic, or retail pharmacy
What are the requirements on sealing of CS?
on each commercial container of CS there shall be securely affixed to the stopper, cap, lid, covering, or wrapper, a seal to disclose upon inspection any tampering or opening of the container
Where is the form available to make changes to pharmacist name, address, or email?
on the Board of Pharmacy website
If poison not sold pursuant to a prescription, must have what label affixed?
one that says "poison" on the label with name of place of business of seller both printed in red ink and name of poison must also be on label
Transfer of CS prescriptions is generally permissible how many times?
one time only
For non-sterile solid and liquid pharmaceutical products repackaged into unit dose or single unit containers, what is the beyond use dating per USP?
one year or less (unless stability data or the manufacturers labeling indicates otherwise)
Methadone may only be dispensed in retail setting for what? Methadone cannot be dispensed in retail setting for what use?
only dispense for analgesia; cannot dispense for detoxification or maintenance of detox
Oral orders for CII drugs in LTCF are permitted when?
only in bona fide emergency
When a pharmacist is not available to, drugs and biologics must be removed from storage area by who?
only personnel designated in the policies of the medical staff and pharmaceutical service in accordance with Federal and State law
Pharmacy also needs to take steps to ensure that PHI is limited to which persons?
only those who have a right to access PHI
Oral orders for medications in LTCF are only accepted when?
only under circumstances where it is impractical for the orders to be given in a written manner by the responsible practitioner
What is a situation where a search warrant would be issued for a pharmacist?
only when a law enforcement official convinces a judge that a crime has been or will be committed and that relevant evidence exists at the site to be inspected
Pharmacies that utilize or act as central fill pharmacy or central processing center myst have what?
operating policies and procedures to include audit trail that records and documents the central prescription process and the individuals accountable at each step in the process for complying with applicable law and regulations including those applicable to recordkeeping
What is naloxone?
opioid antagonist used for patients that overdose and restore breathing by blocking the effects of opioids on the brain
Patient package inserts are required for which drugs?
oral contraceptives and estrogens
Any loss or disappearance of a SLCP must be reported to DEA how?
orally ASAP and then followed up with a written report within 15 days
Pharmacist may only administer injectables, immunizations, or biologicals under what?
order or written protocol
If OTC meds are maintained in LTCF they need to have what?
original label and name of the resident on the label
Who creates and maintains protocol for pharmacy technician? What do protocols say and who needs to sign?
pharmacy manager creates and maintains written protocol for each tech to specify techs individual duties; pharmacist manager and tech shall both sign and date protocol and each amendment
If permit holder in pharmacy fails to renew in time, what must happen?
pharmacy must cease operation until renewal is obtained
If there are substantial alterations to layouts or fixtures in an existing pharmacy then what?
pharmacy must close
If patient refuses to sign acknowledgement of NOPP, what must the pharmacy do?
pharmacy must make record of this fact and maintain that record for a period of 6 years
If third party auditor finds that pharmacy application doesn't meet requirements for electronic prescribing of controlled substances, then what?
pharmacy must not accept electronic prescriptions for controlled substances that are subject to the additional information requirements
Under the LTC patient access to pharmaceuticals act, what kind of immunity is described?
pharmacy serving the LTCF is immune from civil liability arising from dispensation of repackaged drugs as long as pharmacy properly repackages and relabels the drug
If DEA CS registration renewal form is not received by 30th day before expiration date of current registration, what happens?
pharmacy should contact the local DEA registration specialist or DEA headquarters
How does VA patient in LTCF get their meds? What rules does this have to be in compliance with?
pharmacy within LTCF or who is contracted with LTCF receives the drugs directly from VA drug benefit program in the patient's name and repackage and relabel those drugs so they may be dispensed in unit doses in compliance with the FDA, USP and LTCF policies and procedures
What is a central processing center?
pharmacy, but no drugs are dispensed from it; used to help with obtaining prior authorizations, refill authorizations, etc.
Who may donate legally obtained cancer drugs to a participating pharmacy as part of the cancer drug repository program?
pharmacy, healthcare facility, manufacturer, or wholesale drug distributor
In conjunction with logbook, retailers are required to ask for what during sale of SLCP?
photo ID issued by either state or federal government or other appropriate ID (list of forms of ID available in CFR; even report card is listed as acceptable ID)
PDMA requires that requests for drug samples be initiated by who? How is request initiated? And where do drug samples need to be stored?
physician must request in writing; have to store in hospital pharmacy, NOT retail and receipt must be issued
Who can request non child-resistant packaging? How may the request be made?
physician or patient; oral or written
If going to do drug therapy management need to identify who?
physician responsible for authorizing drug therapy and pharmacist authorized to perform the drug therapy management
Who is in the P&T committee?
physicians, nurses, pharmacists
Who has to register as part of No blood, no drug program?
physicians, pharmacists, patients
Pharmacy that uses AMS to fill prescriptions or med orders needs to have what in case of emergency?
plan for recovery of disaster that interrupts the ability of the pharmacy to provide services
Emergency kits should be under control of who?
practitioner authorized to dispense or prescribe medications under the pharmacy act
Medications in LTCF shall be administered by the same licensed person who did what? When does it need to be given?
prepared the dose for administration;l ASAP after dose is prepared
In order for LTCF resident to receive medications that he/she is eligible to receive from the VA, what needs to happen? (who needs to sign what?)
prescriber needs to sign Prescriber consent form and patient, parent, guardian, or authorized family member or someone with POA needs to sign Authorization to administer repackaged and relabeled medications
Responsibility for proper prescribing and dispensing of CS is upon who?
prescribing practitioner
under durham humphrey drugs that are safe only under the direction of physician require what?
prescription
In order to dispense schedule V cough preparations containing codeine, dilaudid, or other narcotic, need what?
prescription (unless in institution)
Practitioners cannot use what to obtain CS for supplying the individual practitioner for general dispensing to patients? What do they need to use to obtain CS?
prescription; need to use DEA 222 form for CII, or invoice for CIII-CV
What records cannot be kept centrally?
prescriptions, inventory records, and executed 222 order forms (centrally kept records may include unexecuted 222 form)
No DEA registrant may employ an individual who has access to CS if that individual has previously had what?
previous conviction of felony offense related to CS or who at any time had an application for CS registration denied, revoked, or surrendered for any cause (individuals who find themselves in this situation can request a waiver from the DEA from this prohibition)
What is an automated medication system?
process that performs operations or activities related to storage, packaging, dispensing and distribution of medications and which collects, controls, and maintains all transaction information (DOES NOT include automated counting device or unit based dispensing cabinet)
If manufacturer produces multiple sizes of an OTC drug that require CRC they are allowed to do what?
produce one of the package sizes in a non-CRC packaging, provided it has the statement "This package for households without young children" or "package not child-resistant"
For Impairment program, board will appoint what?
professional consultant who is a licensee of the board with education and experience in identification, treatment, and rehabilitation of persons with physical or mental impairments to act as liason between board and treatment programs (like drug and alcohol)
Symbol with CS schedule has to be printed how on bottle?
prominently located on the label or the labeling of the commercial container and shall be large enough to afford easy identification of the schedule of the CS upon inspection without removal from the dispenser's shelf (there were formerly height requirements for the lettering, but now as long as it can be seen when walking by its okay)
What claims does the DSHEA allow manufacturers of dietary supplements to make?
promote substantiated structure/function claims which would normally classify the product as a drug (this is one of the claims under the FD&C Act definition of drug)
Pharmacies will be expected to do what if there is probability that PHI was compromised?
provide documentation for how they handled the situation and how they evaluated the probability that PHI was compromised
What do pharmacies have to do as part of ER/LA Opioid REMS program?
provide updated one-page med guide with prescription including info on safe disposal of ER/LA opioids and instructions for when to contact the prescriber before changing dose, signs of potential overdose, and emergency instructions, and safe storage to prevent exposure to family members
Midwives may only prescribe what medications after consulting with a physician?
psychotropic drugs
Who completes DEA 222 order form?
purchaser
If purchaser executes a new order in DEA CSOS to replace lost order, what needs to happen?
purchaser must electronically link an electronic record of the second order and a copy of the statement with the record of the first order and retain them both
If a DEA CSOS is determined to be lost before or after receipt by the purchaser, what must happen?
purchaser must provide a signed statement including unique tracking number and date of the lost order and state that the goods covered by the first order were not received through loss of that order
If purchaser has already signed for ordered controlled substances from online pharmacy and then reports they are lost or stolen, who is responsible for reporting the loss? What form must be submitted?
purchaser or whoever has signed/taken custody of the shipment; submit DEA form 106
Logbook requirements for SLCPs do not apply to what?
purchases of single sales packages that contain no more than 60 mg
Who can write prescriptions for Subutex or Suboxone?
qualified physicians with an X DEA number
Oversight of pharmaceutical services in LTCF will be responsibility of who? What needs to be developed?
quality assurance committee; will develop written polices and procedures for drug therapy, distribution, administration, control, and accountability and use with input from pharmacist
emergency kits should be available how? How should they be secured?
readily available to staff and have breakaway lock which shall be replaced after each use
In institutional setting, secure emergency medical kit needs to be available how? Who controls the kit?
readily available; under control of either the pharmacy, practitioner licensed by law to prescribe or dispense drugs or during an emergency periods, a staff member designated by the chief executive officer, or his/her designee
Inventory records for CIII-CV must be ____________ _______________
readily retrievable
DEA requires what kind of computer updating if pharmacy is going to partially fill CII scripts?
real time updating of computer info and ability to readily retrieve original Rx info and listing of all partial fills
Pharmacist should ensure what if getting emergency CII script?
reasonable effort must be made to ascertain that the oral authorization came from a registered individual practitioner
Mailing of what prescription drugs is prohibited?
reconstituted antibiotics (presumably the mailing of unreconstituted antibiotics is permissible)
Besides request for help in destruction of CS, what else does form 41 cover?
record destruction of all controlled substance inventories as well as destruction of controlled substances that are collected from ultimate users
When a purchaser receives a shipment after ordering on DEA CSOS what do they have to do?
record the quantity of each item received and the date received; record must be electronically linked to the original order and archived
What does emergency prescription mean?
refill of a prescription which is essential to the continuation of therapy in a chronic condition for which the refill has not been authorized and for which the pharmacist notifies the prescriber within 72 hours that an emergency prescription has been dispensed
What does the Matters of Conscience Statement of policy state?
reflects a common sense approach by the board to balance the religious, moral, or ethical objections of a pharmacist with the needs of the patient
Patient should be given a right to do what when it comes to drug therapy management?
refuse the DTM/MTM
Pharmacies who want to dispense thalidomide have to do what?
register and comply with patient identification and monitoring criteria
Who may sign the DEA 222 order form?
registrant or by someone who has been given the power of attorney to execute the form
Who must appoint a CSOS coordinator? What does CSOS coordinator do?
registrant; coordinatory will serve as the registrant's agent regarding issues pertaining to issuance of, revocation of, and changes to digital certificates issued under that registrant's DEA registration
Who can sign orders on the DEA CSOS?
registrants and individuals granted power of attorney who have digital certificates to sign orders
What does the S.T.E.P.S program entail?
registration of thalidomide prescribers and pharmacies, extenstive patient education about the risks associated with thalidomide, registry of all patients receiving thalidomide
Compounding Quality Act does what?
reinstated the compounding provisions included in FDAMA and removed unconstitutional provisions related to compound advertising
IF registrant has not renewed DEA CS registration approximately 50 days before expiration, what will happen?
renewal application is sent to the registrant at the mailing address listed on the current registration
Manufacturers have to do what if a device causes deaths or serious injuries?
report it the FDA
If pharmacist holds license in another state, and has disciplinary action taken in another state, need to do what?
report this on biennial registration, application, or within 90 days of final disposition, whichever is sooner
Must record dispensing of cancer drug on what?
repository dispensing form
Must record receipt of cancer drug on what?
repository donor form
What does the attorney general have to do before setting the schedule of a medication?
request a scientific and medical evaluation of the drug from the Secretary of the Department of Health and Human Services
What did the Narcotic Addict Treatment Act of 1974 do?
required practitioners who wished to conduct maintenance or detoxification treatment for addicts using controlled substances to do so only by being separately registered by the DEA as narcotic treatment programs (NTPs)
When Act 43 was signed in (october 7, 2015) what did this do for non-resident pharmacies?
required that nonresident pharmacies register with PA state board of pharmacy prior to shipping medications into the commonwealth
Patients who may take TIRF need to do what?
required to sign patient-prescriber agreement form
What is the National Precursor Log Exchange (NPLEx)? What act is it in compliance with?
requires that all retailers that sell PSE over the counter must submit electronic transactions to NPLEx by April 5th 2014; HB 602 Act 53
When are ETASU used?
reserved for drugs associated with a serious risk of adverse drug experiences that would otherwise be denied approval or withdrawn
What ETASU does the isotretinoin REMS program employ?
restricted distribution
If retail pharmacy contracts with private, common, or contract carriers to retrieve filled prescriptions from central fill pharmacy, who is responsible for reporting if loss occurs? Using what form?
retail pharmacy; DEA form 106
When a registrant wishes to discontinue a business and not transfer it to another person, what must happen in regards to CS?
return certificate of registration together with any unused 222 forms to the DEA at the Washington DC office and complete DEA form 41 and wait for response of how to destroy CS
Once license or registration is revoked, board requires that individual do what with it?
return it in the manner as board directs
A pharmacy can at any time forward CS for destruction to who?
reverse distributor
OTC monographs also define what?
safety, effectiveness, and labeling of all marketing OTC active ingredients
A pharmacy does not need to register as a distributor (if they distribute to another pharmacy or physician) of CS as long as what?
sales amount to less than 5% of all controlled substances dispensed and distributed in a year
Tax free alcohol can be used for what?
scientific, medicinal and mechanical purposes, and in the treatment of patients
What is Phase IV of clinical testing in humans?
studies performed after a drug has been granted FDA approval
If executing another order form after losing filled out DEA 222 order form, what info must be on the order form?
serial number, date of the lost form, statement stating that the goods covered by the first order form were not received through loss of that order form
What are Good Manufacturing Practices?
set of regulations that establish minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product
Title II of drug Quality and Security Act of 2013 does what? Who does it apply to?
sets a timeline for implementation of a "track and trace" pedigree program, beginning 1/1/2015, manufacturers must pass transaction data to subsequent purchasers. Wholesalers, and repackagers must also pass transaction data along (under any method, paper or electronic); applies to manufacturers, wholesalers, repackagers, dispensers
The Final Rule for Disposal of CS does what?
sets requirements for DEA registrants that voluntarily decide to establish disposal programs to collect unwanted CS from ultimate users; allows numerous DEA registrants to become authorized to establish disposal programs including manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics, and retail pharmacies
If impaired professional enrolls into approved treatment program and enters into an agreement with the board, what can happen to license?
shall be suspended or revoked but enforcement of suspension or revocation shall be stayed for the length of time the professional remains in the program and makes satisfactory progress, complies with terms of agreement and adheres to any limitations on his practice imposed by the board to protect the public
If dispensing emergency CII, quantity dispensed should be how much?
should only be enough to get the patient through the emergency period
If you are going to advertise 20% of sales of drugs, myst do what?
show a price list from which derived
If pharmacist allows license to lapse for 1 year or more and wishes to reactivate, what must they do?
show current proficiency to practice pharmacy (can be through full-time practice of pharmacy in another state)
If computer does not have capability to print out each day's CS prescription refill data, what must pharmacist do each day to document any refill information entered into the computer is correct?
sign a logbook or separate file each day, verifying the accuracy of the refill information by the pharmacist
Physician telephone and oral orders for medications in LTCF need to be dated and signed when?
sign by prescribing practitioner within 48 hours
Cannot dispense cancer drug to a patient who does not have what?
signed cancer drug repository informed consent form
Each change to AMS policy/procedure needs to be what?
signed or initialed by the registered pharmacist manager and include the date on which the registered pharmacist manager approved the change
What is an Administrative Inspection Warrant?
similar to search warrant, but judge will issue AIW given probable cause of serving a valid public interest (much easier to get AIW than search warrant)
What is iPLEDGE?
single pregnancy risk management program for prescribing and dispensing of all isotretinoin products
What is a blanket waiver request for non-CRC?
single request that all subsequent prescriptions be in non-CPC
What is microprinting?
small print which will be shown with magnification, but not upon copying
Persons who wish to dispense controlled substances using an electronic prescription must have what?
software that meets requirements of the rule
Failure to comply with central record keeping requirements can result in what?
special agent in charge of the Administration may cancel the central record keeping authorization without a hearing
How does institution need to meet storage of CS, alcohol and other prescribed drugs
special locked storage space
Institutional Medical staff by laws need to specify what?
staff who are qualified to accept oral orders, to include the ability of pharmacists to accept and transcribe oral orders pertaining to drugs
What is it called when pharmacist has protocol with physician to administer injectables?
standing order
Who dictates which health professionals are allowed to have prescriptive power?
state (this includes for CS prescribing)
What is a pedigree under PDMA?
statement of origin that identifies each prior sale, purchase, or trade of a drug, including dates of transactions, and names and addresses of all parties to them
What must CS prescription have on label?
statement saying "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
For chain pharmacies, it may be more feasible to do what with controlled substance records? Is this allowed?
store them at a central location; is allowed by DEA if they are notified 14 days in advance, in triplicate by registered or certified mail, return receipt requested
Any state law or regulation can be ____________ than it's federal counterpart as long as what?
stricter; as long as it doesn't conflict
If non resident pharmacies had application into commonwealth before march 1, 2016, what did this allow to happen?
they could continue shipping medications to their PA patients during the application approval process (which took place over 120 days)
Class III medical device definition? Examples?
those devices requiring pre-market approval because they are life supporting, life sustaining, or they present a potential unreasonable risk of illness or injury; Ex: pacemaker, heart valves, or soft or hard contact lenses for extended use
acceptable return to stock of undelivered medications refers to what?
those drugs that are still in possession of the pharmacy (i.e. in the pick up bin that were never picked up by a patient)
Class II medical device definition? Examples?
those for which general controls are insufficient to ensure safety and effectiveness, must meet specific performance standards established by the FDA; Ex: insulin syringes, thermometers, diagnostic reagents, soft or hard contact lenses for daily use, electric heating pads
Which types of pharmacy applications are okay to use for accepting electronic CII scripts?
those that comply with all of the DEAs requirements as set forth in 21 CFR 1311
Class I medical device definition? Example?
those that require the least regulation; general controls are adequate to insure safety and efficacy; Ex: needles, scissors, stethoscopes, toothbrushes
Where are regulations for pharmaceutical services for LTCF?
title 28, chapter 211.9
What is the purpose of USP <800>?
to describe practice and quality standards for handling hazardous drugs in healthcare settings and help promote patient safety, worker safety, and environmental protection and ways to minimize exposure to hazardous drugs in healthcare settings
Why are REMS programs created?
to ensure benefit of drug outweighs risks
What is the purpose of a PDR?
to help assure that a drug dispensed is not likely to have an adverse medical result; used as an attempt to identify potential drug therapy problems
In the context of HIPAA regulations, what is marketing defined as?
to make a communication about a product or service that encourages recipients to purchase or use the product or service
Prescription monitoring program laws also have liability built in for what? However, also notes what?
to protect pharmacists for submitting information or not seeking information from the program prior to dispensing (however criminal and civil penalties are built in if one is using database for fraudulent or criminal purposes)
Abuses and losses of CS must be reported to who?
to the individual responsible for the pharmaceutical service and to the chief executive officer as appropriate, and to all parties in accordance with federal and state law
Section 503A of CQA under the DQSA (FDCA) deals with what?
traditional compounding and describes conditions under which certain compounded human drug products are entitled to exemptions from compliance with GMPs, labeling with adequate directions for use, and FDA approval prior to marketing
Glaucoma certified optometrists require what?
training beyond already acquired therapeutic certification
If DEA doesn't say no to transfer of business to another individual, what can occur on the day of transfer?
transfer can occur as long as they don't say no, must complete CS inventory on day of transfer (transfer of CIIs through DEA 222 form) and CS records must be transferred
DEA form 41 should NOT be used to record what?
transfer of CS between pharmacy and reverse distributor who is disposing of drugs
What is short term detoxification treatment?
treatment for a period not in excess of 30 days
what is long term detoxification treatment?
treatment for period more than 30 days, but not in excess of 180 days
Females of childbearing potential need to use what when using isotretinoin?
two forms of effective contraception simultaneously
Transfer of scripts must be communicated between who?
two pharmacists
What is a breach of PHI?
unauthorized acquisition, access, use or disclosure of PHI, including electronic PHI
What is the status of General chapter <800> and when will it become official?
was published Feb 1, 2016 in teh First Supplement to USP 39-NF34 and delayed official implementation date of July 1, 2018 to allow entities additional time to implement the standard
In 2013, what happened with Plan B sales?
were allowed to be OTC; generics were allowed OTC shortly thereafter with NO AGE REQUIREMENT
What is cancer drug repository program?
where unused cancer drugs may be re-dispensed to cancer patients by pharmacies approved by the Board for the purpose of dispensing unused cancer drugs to PA residents who are indigent (poor/needy)
What is another important consideration in determining OTC vs prescription status? What is an example?
whether it meets adequate directions for use requirement; Ex: meclizine sold OTC for motion sickness, but if for vertigo is considered prescription item because adequate directions for use requirement cannot be met on the OTC label; also ibuprofen can be OTC for mild pain, but when used for RA or OA it is a prescription item
Thus, if central fill pharmacy is filling scripts for retail location and then scripts are shipped, who is responsible for reporting if lost/stolen?
whoever contracts with the shipper
Out of the two parties exchanging CII drugs, which party completes the DEA 222 form?
whoever is RECEIVING the CS
iPLEDGE requires registration of who?
wholesalers distributing isotretinoin, healthcare professionals prescribing isotretinoin, pharmacies dispensing isotretinoin and all male and female patients prescribed isotretinoin
Board of pharmacy has _____ ____________ to impose penalties on either pharmacist or permit holder. What does this mean?
wide latitude; means no automatic link between specific infarction and specific penalty
Spilled or damaged controlled substances that are NON-recoverable are required to be destroyed how and reported how?
will already be non-recoverable (duh); simply record in CS records (with 2 witnesses needed), but NO DEA 41 form
In institutional setting, what label requirements apply?
will comply with label requirements under CSDDCA and PA pharmacy regs (same as retail)
If DEA approves modifications to CS registration, what will happen?
will issue a new certificate, which must be maintained with the old certificate
An approved provider who makes a disclosure on treatment of an impaired professional will or will not be subject to civil liability for disclosure?
will not
How soon before change in personal address does the pharmacy need to notify the board? Why is this limited?
within 10 days of the change; because address on file is the official address for serving notices to you (i.e. if board has to notify you that a complaint has been lodged against you and you have limited time frame to respond and don't board will consider it failure to respond if it is due to an address change)
When patient requests access to or a copy of his or her pharmacy records, the pharmacy is required to respond in what time frame? what does this involve?
within 30 days; involves literal access to copies of your prescriptions or your printout of prescription activity
Need to notify PCP if injectable is given within what time frame?
within 48 hours upon administration (for any age)
If patient requests amendment to their records, pharmacy must respond in what time frame? Example?
within 60 days; Ex: if pharmacist inadvertently put someone else's prescription information on your patient profile and once you become aware of it, and you ask the pharmacist to change the records
A prescription written for a CS for an animal would not list what? What would it list on the script?
won't list animal's name; will list species of animal and name and address of the owner
If prescriber wishes pharmacy to dispense brand name medication, what do they need to do?
write "brand necessary" or "brand medically necessary" on prescription
Once received donation of cancer drug must provide donor or designee with what?
written acknowledgement of any donation of cancer drug
Retailers must maintain a ______________________________________ of information on transactions involving SLCP products
written or electronic log book
Order from a prescriber for injectable can come in what format?
written, oral, or electronic
If intern hours are acquired in another state can they be transferred to PA?
yes if the experience gained is shown to be substantially equivalent to that required in PA
Can narcotic controlled substances be mailed?
yes; law previously stated only non-narcotics, but has since been amended
Can supplier choose not to accept DEA CSOS order? What are the requirements with this?
yes; need to make statement that the order is not accepted and link the statement of nonacceptance to the original order and it must be retained 2 years
Can the DEA show up unannounced to inspect central records?
yes; without warrant of any kind
