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181 Cards in this Set
- Front
- Back
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what is required on all electronic rx
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NPI number. National Provider Identifier
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what is required on all controlled substance rx but not required on dangerous drugs rx
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DEA number
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TF: electronic transmitted scripts for controlled substances are now allowed
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true. slides say federal law can allow it.
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TF: electronic rx doesn't need date and time of transmission
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false, needs both.
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encryption of the prescriber's system for electronic CS rx requires 2 of what
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something you know - password
something you have - hard token something you are - biometric, fingerprint/iris scan |
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TF: even if a CS rx was transmitted via SureScript, RPh must still call to verify
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false. RPh can assume it has been appropriately verified. burden is on prescriber
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what is an important difference in GA between what is acceptable for an electronic rx vs a fax rx
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electronic - electronic signature is ok
fax - electronic signature is NOT ok |
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TF: any SureScript rx that gets converted to a fax rx cannot be used
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false, you can use it if it originated from SureScript
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TF: for a CS, a signature stamp can be used for a physical copy rx
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false, must be physician's handwriting and must be on security paper if not an electronic rx
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what are some important requirements for an oral rx
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date, time, and name of person making transmission
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TF: institutional oral rx doesn't need the name of the individual who transmitted it
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true, institutional is exempt from the name requirement
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what are 2 differences between a law and a regulation
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law = legislative process, hard to change
regulation =administrative process(the board); easy to change |
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what are 2 things needed for a PA prescription
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delegating physician's name and phone number. these can be preprinted on the rx, doesn't have to be by hand
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what is the maximum time that a PA and APRN's rx is valid?
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12 months
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TF: a PA or APRN can write a rx for a C3-5 without a co-signature if it's included in the job description or nurse protocol and if the PA or APRN has DEA registration
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true
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what is specifically required on an rx from a PA and an APRN in the state of GA
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NPI number
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an APRN rx is only valid for 12 months. what are the 3 exceptions that make this 24 months
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1. oral contraceptives
2. hormone replacement therapy 3. prenatal vitamins |
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TF: in georgia, you can accept rxs from PA or APRNs that are from other states
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false
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what are 2 restrictions placed on physicians for when they prescribe controlled substances
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they must be acting in the usual course of his or her professional practice.
the order must be for a legitimate medical purpose |
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TF: physican should not prescribe for family(it is discouraged) or for someone who is not that physican's patient
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true
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TF: it is legal for a physician to self-prescribe, except for controlled substances
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true
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TF: physician can prescribe controlled substance for a family member in an emergency situation
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true
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TF: it is not ok to use either a dangerous drug or controlled substances for office use
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false. it's ok to use dangerous drugs with an invoice sale. but not ok for CS
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TF: in georgia, it is allowed for an RPh to not fill a script if it is against their ethical or moral beliefs
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true
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as an RPh, what do you do with an illegal rx if the pt wants it back
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does not have to return. give to law enforcement
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who owns an rx before and after it's filled
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before - pt
after - RPh should keep it for filing |
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what are the refill expiration dates for C3-5
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lesser of 6 months or 5 refills
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what is it called when a patient no longer is seeing their physician, and is given 6 months to find a new physician to get their refills for their dangerous drugs
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continuity
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what happens if a pt needs a refill but they're out and you are unable to contact the practitioner
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can give a 72 hr supply, but need to document it as a new non-refill script. also document on pt's record and the new document the circumstances which warrant such dispensing
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what do the state laws say about how long you keep a rx on file
what about a patient profile |
2 years. also still need to keep 2 years even if you close a pharmacy.
5 years for patient profile |
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what is the caution label that goes on CS
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Caution: Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed
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what is the max beyond use date per USP/NF guidelines
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12 months.
or 25% of time remaining on original container product |
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TF: homeopathic products are not exempt from the USP/NF beyond use date guidelines
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false. homeopathic products ARE exempt
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TF: there exists special procedures for destroying controlled substances
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true
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TF: wholesalers are bound by law to take back drugs a certain number of months before the expiration date
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true
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what act protects children under 5 years old by making Child Resistant Packaging (CRP)
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Poison Prevention Packaging Act
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what does the Poison Prevention Packaging Act entail
what are the 3 exceptions for this |
All new and refill RX must be in CRP. Exceptions:
1. prescriber request (1 rx) 2. patient request (1 rx or blanket waiver) 3. container to be used in hospital |
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what does the 95% label claim mean for expiration dates
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after the expiration date, the drug is still 95% potent
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what must be on the label if there is no child resistant packaging
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"not for households with small children"
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TF: CRP is required in LTCF
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true
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what happens if a pt requests it once not to use the safety cap
what about if a doctor requests it |
patient - document it one time and it's good for the rest
physician - only good for that 1 rx |
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TF: reversible closures are encouraged by the Child Protection Safety Commission
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false - May use reversible closures, though NOT recommended by CPSC
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what act came about from the tylenol scare.
what does it say |
Federal Anti-Tampering Act 1982
requires instructions on how to determine tampering for the consumer |
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what type of drugs require that you give a medguide with it
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drugs with a narrow therapeutic index
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medguides are required when FDA determines if the following 3 apply:
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1. information could reduce serious adverse effects
2. product - serious risks vs benefits 3. patient adherence to directions, crucial |
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REMS include what 2 things
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1. Medguides
2. PPI - Patient Package Inserts |
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TF: REMS means that drug companies have to communicate with patient and physician to ensure safe use
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true
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what does georgia law say about generic substitution for RPhs?
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you can do generic substitution
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TF: patients or physicians can request brand only over a generic substitution
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true
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what's the difference between pharmaceutically equivalent and therapeutic equivalent
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pharmaceutically equivalent - NOT tested for bioequivalence
therapeutic equivalent - IS bioequivalent |
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define pharmaceutical equivalence
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1. Same active ingredients, strength, etc
2. May contain different excipients 3. Not tested for bioequivalence |
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define therapeutic equivalence
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everything pharmaceutically equivalent but ALSO bioequivalence
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what is a single source product
what is a multisource product |
single source - patent protected product that comes from 1 source
multisource - more than 1 manufacturer |
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what is the orange book
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list of generic equivalents for drug products
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where can you get equivalency codes and ratings
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orange book
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from the orange book. define:
A rated B rated AB rated |
A rated - therapeutically equivalent
B rated - NOT bioequivalent AB rated - may have issues but has shown to be bioequivalent and GA law says it's ok to substitute |
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TF: nothing in the georgia law that says you can't substitute narrow therapeutic index drugs like warfarin, digoxin, theophylline
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true
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the only remaining state that does not recognize Mail-Order Pharmacy
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georgia
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TF: georgia law affects the mail-ordering operations of VA
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false. VA is a federal system
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what is the exception to the mail order rule in ga
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specialty pharmacy - they are allowed to mail prescription meds, but don't label it to make it obvious you have meds in the mail
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TF: closed HMOs can do mailing of prescription drugs
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true
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what are some restrictions for georgia HMO mail-order
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1. no C2 or refrigerated drugs
2. mechanism of determining receipt 3. offer counseling unless refused 4. notice it says nothing about C3-5 5. use FDA and USP guidelines to assure integrity of the drug products |
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when mailing drugs, what is used to determine if the drug's tampered and make sure the temperature is ok
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temperature indicators
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in terms of ranks from the orange book, how does AB1 relate to AB2
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AB1 is not equivalent to AB2, but AB1 is equivalent to other AB1
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TF: for the orange book ranks, AB1 is a better product because of bioavailability than AB2 or AB3 or etc.
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false. the numbers only mean to group products together, neither group is better than the other
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how does HIPAA affect places that provide patient care
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must post Notice of Privacy Practices
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TF: when you make a reasonable effort to not broadcast information about a patient's drugs in a public area, that covers you for liability
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true
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TF: HIPAA allows for non-relatives to pick up drugs for a patient
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true
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TF: it's ok if in a physician group practice, one physician faxes an rx to the main office, which then faxes it to the pharmacy
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false - faxes have to be transmitted directly from the source to the pharmacy
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TF: like the GDNA and the board, law enforcement can come in and take a look at any and all of your records
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false, GDNA and board can, but a law enforcement official needs a subpoena. and then u make a copy of rx, make the officer sign, then file everything including the subpoena
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TF: RPh can release info if (s)he receive a letter from an attorney requesting it
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false, they need a subpoena
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what is the requirement for filling foreign country rxs for some states (GA has no problem with this since we're not on a boarder)
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needs to be a practitioner-patient relationship - important for internet pharmacies
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what does the law say about importing drugs from other countries for personal use
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90 day limit and u have to prove that it's for your personal use. and can't sell them
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what is the failed act that dealt with allowing importing of drugs from specific foreign countries
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Pharmaceutical Marketing Access Act 2005
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what is the Haight Act
what are the 3 components |
deals with controlling internet pharmacies
1. internet pharmacies are required to say where they are physically located, who their pharmacists are, and info that allows you to see if it is a legit type of pharmacy practice 2. makes it easier for attorneys general to prosecute violations of the act committed outside of their state. 3. prohibits dispensing of controlled substances without a "valid prescription". validity means doctor must have seen pt in at least one in-person medical evaluation |
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TF: internet pharmacies all are required to go through certification opportunities
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false, not a requirement
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what is the definition of an addict
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1. lost power of self-control
2. NOT a person who becomes habituated while using a prescribed narcotic |
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TF: anabolic steroids are now a CS
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true
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TF: any physician can treat someone for an addictive disorder
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false, need additional training
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define short term and long term detox in terms of time
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short term - <30
long term - >30 AND not to exceed 180 days |
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what is the difference between list I and list II chemicals
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list I - has legitimate use and is important in manufacturing a violating substance
list II - used in the manufacturing of a violating substance, but not active ingredient |
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what was the purpose of the red C
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to separate out controlled substances in reasonable time
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what is established by the Controlled Substances Act
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DEA
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how long is a DEA registration valid for
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36 months
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if you're the PIC, how does a DEA license relapsing affect you?
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can't sell CS anymore
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TF: FDA says that you have to know whether a drug is a controlled substance by the time you've picked the bottle off the shelf
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false - CS have to have indicated on the label to be seen without taking the bottle off the shelf
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how are drugs ranked as CS
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by their abuse potential. C1 is highest potential, and goes down from there
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what is the definition of a C1 and what are some examples
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definition - 1. high potential for abuse
2. no currently accepted medical use 3. unsafe? even with medical supervision ex: heroin, marijuana, LSD, methaqualone |
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TF: georgia has marijuana laws for medical use
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true... but none have been activated. not a single patient has gotten it for medical use
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what is the only difference between a C1 and C2
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C2 have a currently accepted medical use
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TF: C2 drugs are mostly single entity drugs
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true - exception: percocet is an example of a C2 that is combo
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definition of C2 drugs have 3 components, list them and list examples
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1. high potential for abuse
2. currently accepted medical use 3. addiction potential ex: meperidine, methylphenidate, barbituates |
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TF: C3s contain combination products of C2s
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true
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TF: C2s can be used for a diagnosis of weight loss
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false, illegal to rx as weight loss
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where do all hydrocodones with different combinations with APAP fall under in the ranking of C1-5
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C3
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list some drugs that are specifically classified as C3 in georgia
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sodium oxybate and ketamine
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how is sodium oxybate abused as
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date rape drug that is a C3 if used therapeutically, but prosecuted as C1 if abused
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TF: The Anabolic Steroids Control Act also includes steroid use in cattle
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false
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TF: tramadol is a CS in ga
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false
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what are some examples of C4 drugs
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alprazolam
carisoprodol benzodiazepines zolpidem phenobarbital pentazocine |
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what are some examples of C5 drugs
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cough preps - robitussin AC, novahistine DH
lomotil - for it's atropine APAP with codeine |
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TF: selling of a C5 requires a prescription
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false - only for some
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what are the requirements for a non-prescription sale of a C5
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1. purchaser sign log - DOB, Name, address (complete)
2. dispense only a 48 hour use quantity - 4oz or 32 units max |
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what are the restrictions for sale of psuedoephedrine
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max 3.6g for 24 hrs, 9g in 30 days
need ID RPh approval |
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how often can a CS be transferred
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once only
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how long can you refill a CS and what is the limit
also, who can transfer a CS |
6 months starting from date of rx issuance, not the filing of the prescription
5 times in 6 months between 2 RPh or intern/extern only (GA does not allow techs to transfer) |
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what steps must you take to transfer a CS
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1. the word "VOID" written on the face
2. on the back: name, address, DEA number of pharmacy 3. date of transfer and name of RPh transferring on back of the drug order |
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what steps must you take to receive a CS transfer
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1.write TRANSFER on the face.
2. date and # of refills on original order. 3. # of valid refills and dates of previous refills (what the law says, but mostly see original and last fill dates) 4. pharmacy's name, address, tele, DEA, and rx serial number from which the script info was transferred 5. name of RPh who transferred the order |
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what does the law say about documenting the date of every past refill on a CS transfer
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it says you need to get the date of each past refill, but in practice you don't see this. see only original date and last refill date.
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TF: turning over logs of psuedoephedrine sales to law enforcements for investigation is a violation of HIPAA
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false
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GA law says you can't have more than X number of pseudopehedrine dosage units
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300
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what are the 3 things that require a log book for sale
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1. poisons
2. C5 psuedoephedrine 3. C5 non-PSE products |
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differentiate between schedule A and schedule B
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A = poisons that have no medical purpose
B = poisons that do (digitalis, belladonna) |
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what form do you need for the destruction of controlled substances
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form 41
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what form do you need to purchase C2s from distributor to pharmacy
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form 222
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TF: even State Drug Inspectors need to document and authorize with a DEA
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false - Special circumstance if State Drug inspector is involved…they can document and authorize w/o DEA
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what type of writing utensil must you use for filling out form 222
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must be indelible. so typewriter, pen, or indelible pencil
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how do you fill out form 222 in regards to lines
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one item per line
state the final # of lines to prevent illicit addons |
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TF: each form 222 is serially numbered and preprinted with name, address, and reg number
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true
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who can sign form 222
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PIC, but can add more people if u get power of attorney for other RPhs.
POA can be revoked by executing a Notice of Revocation |
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when you partial fill a form 222 order, how long do you have to finish the order
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60 days, after that it's no longer valid
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what are 2 things that force a form 222 to not be filed
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1. incomplete (i.e. signature)
2. erasures or alterations |
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what happens if someone stole a form 222
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report to DEA and document the serial numbers stolen (each form has a serial)
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what is CSOS and how has it helped
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Controlled Substances Order System - used in place of form 222. it's an online version. no line limits and decreased paperwork
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how is CSOS used
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uses encryption key technology
may authorize additional people, techs to make orders but need power of attorney most suppliers require 2 forms of photo ID |
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how do you deal with a lost CSOS order
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1. purchaser (that's us) most provide signed statement with tracking #, etc. of shipment lost
2. a new order must be linked to that statement, as well as a record of the first 3. if order is "found", mark it as not accepted and returned to supplier 4. purchaser and supplier must retain linked records for 2 years |
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who must retain copies of voided CSOS orders
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purchaser
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what does cancelling a CSOS order entail
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1. if entire - VOID is marked on a copy and sent to purchaser
2. if partial - indicate voided items on electronic record 3. purchaser must retain copies of voided orders |
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how do you dispose of CSs
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1. return to manufacturer
2. destroy yourself with DEA or GDNA supervision (DEA form 41) 3. use reverse distributor |
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what is a reverse distributor and what is unique about using it for C2
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a company that receives CS for destruction/disposal.
if C2 - must use order form to document transfer |
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for compounding with a CS, what do the guidelines say
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1. compound for physician office use only, pt can't go home on it
2. no more than 20% CS 3. cannot resale 4. only give to practitioner who is authorized to use it |
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TF: GA law makes an exemption for pseudoephedrine containing pediatric products <12 yrs
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true
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what are 2 requirements for issuing a CS prescription
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must be within the "usual course" of prescriber's practice
must be for a legit medical purpose responsibility is on the prescriber |
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what is corresponding liability
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when RPh is also liable if they KNOWINGLY fills a CS script that isn't for a legit medical purpose or know it came from a pill mill
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TF: A prescription may NOT be used to obtain CS dosage forms for general dispensing to patients
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true
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what are some exempted practitioners that can write CS scripts without needing a DEA registration
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hospital employee (need DEA # of hospital and code # of individual)
military or public health service physician (need service ID#) |
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TF: pharmacists are usually not individually DEA registered, just the pharmacy
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true
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TF: is a methadone rx from a family physician valid?
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false - only physicians who are board certified in addiction psychiatry can prescribe detox or maintenance therapy for a drug dependent person
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what does it mean if you see a DEA number starting with N, PRST, U, X
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narcotic treatment program DEA registrant
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what does it mean if you get a DEA number starting with B or F
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type A practitioner
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break down the DEA number for me
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2 letters - code for type, first letter of last name
7 letters - check digit system |
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TF: there exists a manner to check for DEA accuracy (like adding digits)
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true
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for a DEA number like AB1234563-010, what does the -010 mean
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DEA number is from a hospital institution, the -010 is the individual practitioner
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what are the 2 options for storage of inventory of CS
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1. locked in a secured cabinet
2. dispersed through stock of drugs |
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what is the employment requirement for pharmacies to sell CS
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no one must have a felony conviction, nor be on OIG list, and not have their license denied/revoked
but a waiver system exists for some conditions |
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what do you do if someone steals some CS
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1. notify local law enforcement
2. notify GDNA and DEA within 3 days 3. fill out form 106, the report of loss form, within 10 days |
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TF: practitioners have to keep records for all CS they prescribe and dispense
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false - just dispense.
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what is PMP/PDMP/RxSentry
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monitoring program for tracking prescribing of CS
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how do you manage record keeping for CS in a pharmacy
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We must maintain purchase and prescription records, and both of these need to be balanced so you know input and output of CS
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how do you file C2s in a pharmacy
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CII – separate file, RPh SIGN and date
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what are the 3 prescription filing options for CSs and which is not an option in GA
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1. 3 parts. C2, C3-5, and rest
2. 2 parts. C2 and rest, but with red C for C3-5 3. 2 parts. C2 with C3-5, but 3-5 have red C, and rest. 3 is not an option in GA |
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for prescription record keeping, what sorting options are available for online records
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practitioner
patient drug date of dispensing |
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how often does the fed say you have to do physical inventory of all your CSs
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every 2 years
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TF: for inventory requirements, you can use central records so long as you get a notification statement for verifying central records
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true
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how do you deal with open containers of CSs, specifically C2 and C3-5
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C2 = need to know exact count
C3-5 = need to know exact count if container has over 1000 units |
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when do you have to re-do/re-start the bi-annual CS inventory
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if DEA registration changes. so if there's a change in PIC or if the pharmacy moves
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what happens to the bi-annual CS inventory if a non-CS drug becomes CS
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redo inventory for that drug only, don't need to do an entirely new bi-annual inventory
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so what are the records you need to keep in a pharmacy that he talked about
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order forms (form 222)
purchase records (if other than 222) inventory records - bi-annual CS inventory dispensing records - rxs and logs reporting theft/loss - form 106 surrender/disposal - form 41 |
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what established the state board of pharmacy in GA
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Official Code of Georgia Annotated
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the 8 member board of pharmacy... what are the requirements to be a member
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1 consumer member
5 year terms (or until successor appointed) appointed by governor diversity of practice - but no absolute requirement for chain RPh, hospital RPh, etc. geographic dispersion |
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TF: you need a chain pharmacist and a hospital pharmacist to be on the 8 member board of pharmacy
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false. just need "diversity of practice"
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TF: members of the board of pharmacy should be elected from all areas of the state
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true - called geographic dispersion
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TF: pharmacists on the board don't need to be actively practicing if they have 5 years of in-state experience
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false. need to be actively practicing, have 5 years of in-state experience, and must have lived in the state for 6 months prior to being elected to the board
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what member of the board handles case summaries and is the hardest working member of the board
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cognizant member. they're usually the vice pres
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TF: all GDNA agents are law enforcement officers and pharmacists
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true
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what are 2 important duties of the GDNA
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report to the board
each year - update dangerous drugs |
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what is the FPGEE
how does it relate to the NAPLEX |
Foreign Pharmacy Graduate Eqivalency Exam.
it matches the accredited phamacy program we have. you still have to take the NAPLEX after |
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what is the board required # of times the board exam can be given
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2x per year. but usually is given 3x
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how many times can you fail the board exam
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3x. you have to get board approval to even try again, and your intern license is revoked
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how long after passing the board exam can you wait before u complete the licensing process
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results of the exam expire 2 years afterwards, so finish getting your license within this time
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what are the components of the board examination process
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NAPLEX
MPJE practical exam - wet lab completed internship |
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what does reciprocate mean for licensing.
what do you need to keep to reciprocate |
reciprocate = another state gives you a license without an exam based on your current "license by exam"
you need to keep your original "license by exam" active |
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what is the florida "license by endorsement" system
|
same thing as reciprocity in GA. can get a florida license if u have an active "license by exam" from another state
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what state doesn't do reciprocity
how do they handle NAPLEX score transfers |
california
they will accept your NAPLEX scores from another state, but they have their own law component |
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TF: if you practice in the federal pharmacy system (US public health and VA system), you can use any state license to practice anywhere
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true. but try to make it the "license by exam" so if you leave the fed system, can still get other state licenses
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when do pharmacists renew their licenses
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on even years (2012, 2014, etc.)
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what does deactivating your license mean
what happens if you wait too long |
you can deactivate your license for 4 years if you don't plan to practice
if over 4 - need to go through internship hours again and take MPJE again, and make up the CE you missed |
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what happens if you let your license expire
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$500 fine
automatic inclusion in the CE audit may be invited to the board for questioning |
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in georgia, how is CE handled
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30 hours bi-annually. can get them at any time in the 2 years.
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for CE, how does the bi-annual system handle new pharmacists entering at different times of the years
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if entering in...
1st 6 months – 30 hours Last 6 months – none In between – 15 hours |
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TF: the board can ask for your CE records from the last bi-annual cycle
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true. so keep CE records for 2 years after your renewal year
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