Jurisprudence questions
If you get an e-script or telephone prescription and the MD says the brand is medically necessary, may you then dispense the brand drug?
Yes, if it is electronic or oral they can just say its medically necessary. If its written it must say DAW or dispense as written on it.
When the mediset is sent to the patient and one of the drugs within the set is discontinued this pack is now considered what?
adulterated
A black boxed warning is required when use may lead to death, ___________________, or ______________________________________________________
serious injury, or collateral measures need to be taken for safe use
How many controlled substances may be on the same prescription?
1
Adulterated drugs shall be stored no longer than _________ from date of adulteration or expiration by those holding a TDDD license
1 year
How long must a patient profile be maintained at the pharmacy after the patient stops filling prescriptions there?
1 year You still have to maintain a list of everything you've filled for them but you don't technically have to keep their profile information after 1 year
When you repackage tablets into unit dose packaging, what should the expiration date be?
1 year from the repackaging date or the original expiration date on the stock bottle, whichever is shorter.
What are the CE requirements for OH pharmacists?
1. 60 contact hours (= 6 C.E.Us) every 3 years 2. Three of those hours in law 3. Two of those hours in Pt or med safety
May anyone other than a pharmacist dispense medication in the state of OH?
No. Dr's may however "personally furnish" drugs to their pts but only a pharmacist may "dispense"
New intern Gracie answers the phone and it is Walgreens wanting to transfer a prescription for tramadol. May she take the transfer?
No. Only a pharmacist can take a transfer for a controlled substance.
Do prescriptions written by advance practice nurses need to be countersigned by their collaborating physicians?
No. The collaborating physicians name doesn't even have to be on the prescription
If the executive director, the president of the BOP, the public representative, and 3 other pharmacist members are present, can the BOP vote?
No. The executive director is not a member, the president does not vote unless there is a tie, and that leaves only 4 voting members. You need 5 to vote
Is anything required if a patient (or caregiver) refuses counseling?
The refusal must be documented in the presence of the patient or caregiver
May a practitioner prescribe a controlled substance to a family member?
Yes, but only in an emergency after they have performed an adequate examination and documented it in the patients record.
Can an OARRS delegate run report?
Yes, but pharmacist MUST interpret it
May prescribers switch the controlled medication in the middle of treatment?
Yes, but still cannot exceed 12 weeks therapy
How often must data be submitted to OARRS?
Daily for pharmacies and prescribers Monthly for wholesalers
What are the two reasons pharmacists should utilize PMPs?
1. Legally required to in most states (Ohio) 2. Pharmacists share a corresponding responsibility with prescribers to ensure that prescriptions are for legitimate medical purpose
What patient information is required on a written prescription?
1. Name 2. Address
The FDA regulates human & veterinary drugs, biological products (vaccines/inj), medical devices and 3 other categories. What are they?
1. Nation's food supply (except meat/poultry bc thats USDA) 2. Cosmetics 3. Products that emit radiation (Xray/Microwave)
What are the two options as of right now to "qualify" technicians?
1. National Pharmacy Technician Certification Board Exam 2. Examination provided by employer after being approved by the board
The FDA requires certain manufacturers of certain medications to supply patients with a patient package insert (PPI) as part of the medications required labeling. What 2 groups of drugs falls under this requirement?
1. Oral contraceptives (estrogen and progestin based) 2. Estrogen containing drugs (conjugated estrogens, diethylstilbestrol, etc.)
What gets reported to OARRS?
1. Outpatient dispensing 2. Personal furnishing (MD offices) 3. Wholesale Sales
What are the requirements an optometrist must follow in order to prescribe controlled substances?
1. must have DEA license 2. must be codeine or hydrocodone containing combo product (≤ 60 mg of codeine per dosage unit./ ≤ 7.5 mg of hydrocodone per dosage unit.) 3. Max 4 day supply
What are the exam criteria for employer based exams?
1. passing >75% 2. supervised while taking 3. ensure security of exam questions
What drugs are included in SLCP?
1. psuedoephedrine 2. ephedrine 3. phenylpropanolamine (not used anymore)
A national drug code number (NDC) is a unique identifier for human drugs made up of 3 segments (i.e. 0069-1540-68). Which segment (1st, 2nd, or 3rd) is given by the FDA? What do the other segments signify?
1st segment- given by the FDA to the manufacturer, all products from the same manufacturer will have the same first segment of digits 2nd segment- product code, sometimes used as the imprint on the tablets/capsules 3rd segment- package code/size
What is the maximum monthly "personal furnishing" a practitioner can provide?
2,500 dosage units for ALL patients of practitioner **** They may only furnish enough control medication for a 72 hour period ****
Which DEA form is used for registration with the DEA?
224
What happens if you override a "stop" due to the patient being over the limit of SLCPs?
2nd degree misdemeanor
How many non controlled substances may be on the same prescription?
3
How long must you keep records of disposals?
3 years
Pharmacist Gracie has accidentally let her license expire/lapse. How long does she have before she'll have to retake her board exams in order to reinstate her license?
3 years. After 3 years you must retake the exam to get your license back
What is the daily sales limit of SLCPs?
3.6g
How many days do pharmacists and interns have to notify the BOP if they change their address?
30
How many days do pharmacists and interns have to notify the BOP if they change their place of employment?
30
JC calls a physician and this is the first year she has been a DATA qualifying prescriber. How many patients can she take?
30
What is the maximum day supply allowed in "medisets"?
31 days
After dispensing a biologic for which an interchangeable product is available, regardless of whether a substitution is made, the pharmacist (or an individual designated by the pharmacist) shall communicate to the prescriber information identifying the specific biological product that was dispensed, including the name of the biological product and its manufacturer. How many days do they have to complete this task?
5 days
You own a chain of 4 pharmacies. All 4 stock and dispense controlled substances. 1 of these 4 provides meds to local nursing homes as well as sells drugs to area physicians group practices at wholesale. How many DEA registrations do you need?
5. 1 for each pharmacy = then 1 additional for the 4th pharmacy that operates as a wholesaler as well
Once a patient has used diet medication how long must they wait until using controlled diet medication again?
6 months
How many days do pharmacists and interns have to notify the BOP if they change their name?
60
How many semesters hours of college must you complete before you can be a pharmacy intern?
60. (90 quarter hours)
What task must occur on the effective date of the change over to the new responsible pharmacist?
A complete inventory of the controlled substances in the pharmacy
If an ambulance wanted to have single dose IV drugs on board but also some pain meds, what kind of TDDD license would they need?
A limited category 3
The board of pharmacy requires pharmacists to conduct a DUR with each new and refill prescription. Which of the following may may be imposed by the board of pharmacy if you fail to conduct a DUR: (select all the apply) A. Extra CE B. A monetary fine C. Suspend your license D. Jail time
A, B, & C. The board of pharmacy can not give you jail time because it is an administrative agency. They right 'rules' which are laws but are not enforceable to the extent of a 'statute'. (You can go to jail if you break a statute)
How long are the following prescriptions good for from the date written? A. Non-controlled B. C-V C. C-II, III, or IV
A. 1 year B. 1 year C. 6 months
How many refills may a prescription for the following medications have? A. Soma B. Adderall C. Diazepam D. Lyrica E. Phenobarbital F. Cyclobenzaprine
A. Soma- 5 refills (CIV) B. Adderall- 0 refills (CII) C. Diazepam- 5 refills (CIV) D. Lyrica- up to a year (CV) E. Phenobarbital- 5 refills (CIV) F. Cyclobenzaprine- up to a year (noncontrolled)
Fast forward 20+ years from the date the patent for RZ43 was originally filed. A competitor company would like to manufacturer a generic version of RZ43. What type of application must they file with the FDA? What must they prove in this application?
Abbreviated new drug application (ANDA), only have to prove bioequivalence to innovator drug
To be pharmaceutically equivalent what aspects must be the same as the innovator drug?
Active ingredient, strength, dosage form, & route of administration (color, shape, and inactive ingredients can be different)
damages is split into 2 categories, actual and punitive. The purpose of actual damages is ____________ while the purpose of punitive damages is _____________.
Actual --> compensation Punitive --> punishment/make an example of the defendant
What are the CIV drugs approved for weight loss?
Adipex-P Tenuate (diethylpropion) Qsymia (phentermine/topiramate XR) Belviq (lorcaserin)
When must the following prescriptions be filled *for the first time* from the date written? A. Non-controlled B. C-V C. C-II, III, or IV D. Opioid containing product
All are 6 months except for opioid containing products must be filled within 14 days from date written or 'do not fill before' date
What medications are included on OARRS?
All controlled substances (II-V) and gabapentin
Which of the following could be an element of a REMS program? (Select all the apply) A. Medication guide B. Communication from manufacturer to healthcare providers about associated risks of the medication C. Elements to assure safety use, for example a registry for clozapine prescriptions with mandatory ANC to fill prescription D. An implementation system where the manufacturer is responsible for monitoring and evaluating if healthcare providers are implementing the registry system mentioned above.
All of the above may be elements of a REMS program
How often must "self certification" to sell SLCPs be renewed?
Annually
What immunizations can you administer as an intern?
Any that a pharmacist can give (we must stay CPR certified)
Annual TDDD license is renewed on:
April 1st
Up until recently your company has not worried about competition from generic companies, however in 2010 the Affordable Care Act created an abbreviated licensure pathway for biological products that are demonstrated to be "biosimilar" to or "interchangeable" with an FDA-licensed biological product. What was this act?
Biologics Price Competition and Innovation Act of 2009 (BPCI Act)
Who in Ohio is in charge of regulating medical marijuana?
Board of Pharmacy
What are the CIII drugs currently approved for weight loss?
Bontril (phendimetrazine) Didrex (benzphetamine)
To be considered a dietary supplement what route of administration must it be through?
By mouth
How does Ohio classify ephedrine containing products?
CV
What class of recall is this: A food says its pre-cooked but isnt.
Class 1
What class of recall is this: Coumadin tablets may have more than the 5mg it says in some tablets
Class 1
Which class or classes of recalls require written notices from manufacturers to wholesalers and pharmacies?
Class 1 & 2
What class of recall is this: A bottle has thin walls that may allow light in and alter product
Class 2
What class of recall is this: Drug lacks an english label
Class 3
What class of recall is this: drug bottle has no desiccant pack
Class 3
If you voluntarily seek help with PRO is it confidential and anonymous?
Confidential but NOT anonymous. must provide a name and reason why you think an impairment exists
Would you fill it?: A physician's assistant (PA) who prescribes Ritalin®
Depends. No if its out of a convenience care clinic but yes if its at the normal practice site and the physician already initiated it or the PA consulted with the physician first
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: Body fortress Whey protein powder
Dietary supplement
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic, or something else: Vitamin B12 injection
Drug
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: FeverFew herbal supplement --"for prevention of migraines"
Drug -- only bc it says it prevents migraines. if it said something like "minimizes neurologic discomfort" it'd be a dietary supplement
While the food, drug, cosmetic act of 1938 only applied to drugs after 1938, the Kefauver-harris amendment was retrospective. What project went back and looked at prescription drugs from 1938-1962 to check for efficacy?
Drug efficacy study implementation (DESI) project. **Drugs before 1938 were also grandfathered in as being effective**
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: Under arm deodorant/Antiperspirant
Drug. will have a drug facts label on it bc aluminum in products stops sweating --> alters the body
True/False: A controlled substance may be e-prescribed from a prescriber's computer to the pharmacy's computer system or fax machine as long as both transmission systems are DEA certified
False, *electronic prescriptions* for controlled substances may only be sent directly from the prescribers computer to a pharmacy's computer system, not faxed. *CIIs may never be faxed*(ok to send electronic noncontrolled prescriptions to the pharmacies fax machine though)
True/False: You may substitute an AB1 product for an AB2 or AB3 product because they still have the same AB rating, just with different number categories.
False, If they have a number after the AB rating that must match as well to be generically equivalent
True/False: Pharmacist only have to conduct a prospective drug utilization review (DUR) on new prescriptions.
False, new and refill prescriptions require a DUR
Name this act: 1. regulated the production, importation, and distribution of opiates and coca products 2. required licensure for manufacturers, importers, pharmacists, and physicians prescribing narcotics 3. in 1924, prohibited the importation of heroin
Harrison Narcotic Act of 1914
"Doctrine of negligence per se" means what?
If a pharmacist violates a statute or regulation, the violation in itself could establish negligence
A pt brings you a Rx for methadone. May you dispense this?
If it is for pain, yes. If for addiction, no, must got to OTP.
Name this act: 1. first federal statute to protect us from harmful drugs 2. prohibited importation of adulterated drugs 3. CAUSE: adulterated quinine (anti malaria) with all active quinine taken out of the bark was sold to american troops
Import drug act of 1848
Who owns a prescription?
Information on a prescription is the property of the patient and is intended to authorize the dispensing of a specific amount of medication for use by the patient. The pharmacy owns the hard copy after it is filled
Our R&D team recently completed several studies using compound RZ43 that revealed beneficial effects on blood pressure in rats. What is the next legal step in order to perform testing in humans?
Investigational new drug (IND) application
How does comparative negligence differ from contributory negligence?
It is now possible to reduce a plaintiff's recovery by the percentage that corresponds with the percentage of fault attributed to the plaintiff. Thus, assume that a plaintiff was harmed and the dollar value of the harm was determined to be $100,000. If the plaintiff was assigned 20% of the fault, and the defendant was assigned 80% of the fault, the plaintiff's recovery would be reduced by $20,000
What is the requirements for eRx to be DAW since the prescriber can't write DAW or dispense as written on it as they normally would?
It must require positive action. The transmission system cannot default to DAW on its own, it has to be a manual change
Your company ultimately wins the patent infringement trial because the generic company did not wait until the patent on your tablet coating process expired. Your company wants to maximize RZ43's time on the market so it produces an "authorized generic" of RZ43 under a private label. What is the benefit of doing this?
Its the brand name company making their own generic, dont have to file an ANDA because its the same drug
Who is exempt from the 14 day rule for filling CIIs?
LTCF
May a practitioner self-prescribe or self-administer noncontrolled substances?
Legally yes, but the board of medicine sees this as unethical.
May an advance practice nurse (APN) write a prescription for hydrocodone with the directions 'take 2 tablets by mouth every 6 hours as needed' with a quantity of 240 tablets. (30 day supply)
Maybe. If it is the initial visit, they cannot write for more than a 14 day supply but there is no limit on the quantity they can prescribe after the initial visit.
Would you fill it?: A dentist (DMD) who prescribes Allegra-D®
Maybe. It may be that the pt has bad congestion in the sinuses causing referred tooth pain. He said its a stretch but maybe.
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: Foltx tablets (B12/folic acid/b6) -- "for dietary management of hyperhomocysteinemia"
Medical food -- bc it manages a disease state, usually one that is from a deficiency of something
What is the only oral corticosteroid an optometrist may prescribe? (if the patient is over 18 and is being treated for an individual allergic episode)
Medrol dose pack
What is the CII drug approved for weight loss?
Methamphetamine (Ohio does not allow it to be used)
If you dispense an oral contraceptive or estrogen containing product without a patient package insert, what are you guilty of?
Misbranding
What is MED?
Morphine Equivalent Dosing
What must be the same for a drug to be considered generically (bioequivalent) equivalent?
Must be pharmaceutically equivalent AND virtually the same rate and extent of absorption
What is the certificate requirement for an optometrist (OD) to prescribe in Ohio?
Must have a 'therapeutic pharmaceutical agent certificate' (Does NOT have to be listed on a Rx like a CTP#)
The federal anti-tampering act made what a packaging requirement for OTC drugs, cosmetics, and devices?
Must have tamper evident packaging (not the same as tamper proof)
If a pt calls the number on a dietary supplement or OTC drug and reports a significant event, what must the manufacturer do with that information?
Must submit the information within 15 days to the secretary of health and human services (runs the FDA)
Are MedGuides required for patients in an institution?
No, because a healthcare provider is administering the medication and they know about the risks and what to look for. *but* remember that patient package inserts (PPIs) still are required
A police officer comes into your pharmacy requesting a hard copy of a person's OARRS report, do you give it to him?
NO
Can a pharmacist be a responsible person for more than 1 pharmacy at a time?
NO
May you give your lead technician your OARRS log in information if their password isn't working?
NO
Is OARRS data considered evidence if needed?
NO NO NO!! Have every reason to believe it is accurate, but there are mistakes made by users entering information
May pharmacists provide copies of the OARRS report to patients?
NO. NOT TO ANYONE. No police officers, doctors, patients, NOBODY.
Who can be in the physical confines of the pharmacy when there is not personal supervision by a pharmacist?
NOBODY
What are some drugs that do not have to follow the child-resistant containers rule?
NTG, topicals, blisterpacks
What must be approved by the FDA before we may legally distribute the "new drug" in interstate commerce for patient use?
New drug application (NDA)
Are qualified technicians certified by the board of pharmacy?
No
Do SLCPs have to be kept in a pharmacy?
No
Do cosmetics required FDA approval?
No
You receive a prescription in the pharmacy written by a PA. You do not have the PA listed in your computer system. May you place his supervising physician's name as the prescriber on the patient's prescription bottle?
No, you have to use the name of who prescribed it
Does the BOP have contacts or agents within PRO?
No.
May a pharmacist generically substitute for a brand name drug if the generic costs more than the brand?
No.
The executive director is not a BOP member. Do they have to be a pharmacist though?
No.
Would you fill it?: A podiatrist (DPM) who prescribes oral contraceptives
No.
May providing a MedGuide or patient information sheet substitute for counseling?
No. Other forms of drug therapy information may be used when appropriate to supplement counseling, but it cannot replace counseling
What does OARRS stand for?
Ohio Automated Rx Reporting System
What is required on the label for Mrs. McCormick's dog prescription?
Owner's full name + indication of animal (K9)
The pharmacist must inform the patient they have the right to refuse the generic except for in what patient population?
Patients insured through any agency of Ohio or if they are patients of hospital, nursing home, or similar care facility
The grandfather clause allowed drugs already marketed before 1938 to bypass the new food, drug, and cosmetic act. Name some of these drugs.
Phenobarbital, nitroglycerin, digoxin, aspirin, and Azo
What is one way still get multiple CII prescriptions written at a time, but still follow the 14 day rule?
Prescribers may write do not fill until dates on prescriptions and 14 day rules apply to those dates
The kefauver-harris amendment gave FDA authority to regulate _______________ advertising
Prescription
What does PMP stand for?
Prescription Monitoring Program
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: Drug eluting stent
Primarily a device but also a drug -- always look at primary mechanism for combined products
Pharmacy intern licenses must be renewed annually on ____________ (date)
September 15th
When are CE hour documentations due by in order to count?
September 15th
When must the medical marijuana bill be operational?
September 2018
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: Infant formula
Special dietary food -- supplies dietary need but doesnt manage disease state
A pharmacist that is the responsible person at a pharmacy must sign what license?
TDDD
Name this law: 1. est. first distinction between OTC and Rx only 2. legalized verbal prescriptions 3. legalized refills on prescriptions
The Durham-Humphrey Amendment of 1951
Name the amendment: 1. CAUSE: thalidamide tragedy in europe 2. approval process now requires drugs to prove safety AND efficacy (aka the drug efficacy amendment)
The Kefauver-Harris amendment of 1962
The DESI project looked at prescription drugs between 1938-1962 for efficacy, what looked at OTC drugs?
The OTC drug review
misbranding pertains to representations made on the label or labeling. What is the difference?
The label refers to what is immediately on the container. The labeling includes the label as well as other written, printed, or graphic material upon the article or any of its containers, wrappers, or accompanying material
Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) requires the manufacturers to put what on the label of dietary supplements and OTC drug labels?
The manufacturer or retailers domestic address or phone number so they can report serious adverse events that occur while taking that supplement/drug
What reference book do pharmacists use to determine if products are "generically equivalent"?
The orange book
Scenario: Gabapentin dispensed at VA outpatient pharmacy. Submit to OARRS?
They are not required by law, but most typically do.
Can a plaintiff sue both the employer and also the employee? or do they have to pick one?
They can sue jointly or just pick one to sue
May pharmacists discuss the information on the OARRS report with physicians?
They may discuss the information with prescribers and law officials if they have a relation with the patient/criminal.
What is the goal of OARRS?
To serve as a tool to help health care practitioners combat prescription drug diversion and abuse
As a defense against negligence, what is contributory negligence?
Tort law requires that a plaintiff must act as a reasonable, prudent person in the same or similar circumstance. If the plaintiff could have avoided the consequences of the defendant's negligence by ordinary care, then there is no malpractice under the defense of contributory negligence.
True/False: Federally, at least one in person evaluation is only required for controlled substance prescribing, but in Ohio, this rule applies for noncontrolled substances as well.
True
True/False: If a computer system is DEA "certified" to send or receive electronic prescriptions, it is automatically determined to be approved by the Ohio Board of Pharmacy.
True
True/False: If a patient refuses counseling on their prescription, but no documentation of this occurs, it is assumed that the counseling did occur
True
True/False: In Ohio, bioequivalent drugs are also referred to as generically equivalent drugs.
True
True/False: The pharmacist must inform the patient that a generic is available and they have the right to refuse the generic.
True
True/False: when a pharmacist takes a verbal prescription they must reduce it to writing immediately and include the full name of the prescriber, full name of the prescriber's agent/caller, and positive identification of the pharmacist who took the order
True
True/False: An advance practice nurse may prescribe C-II stimulants approved for ADHD
True, as long as they have a formal established diagnosis from the MD or the APN talked to the MD first before prescribing it
True/False: Preprinted prescriptions still require a manual signature from the prescriber.
True, prescribers signature can't be preprinted or stamped with the rest of the script
True/False: Rx drugs approved after 2001 will be required to remove the pregnancy letter category next year
True, will be replaced with risk summaries/chapters of information in different sections
True/False: A noncontrolled substance may be e-prescribed from a prescriber's computer to the pharmacy's computer system or fax machine
True.
True/False: if you have been convicted of a felony related to controlled substances you may not work in a pharmacy that has controlled substances.
True. Also not if you have had a DEA registration denied, revoked, or suspended
True/False: A written prescription is required to have a phone number printed on it where a prescriber can be reached during normal business hours
True. Must also have the prescribers full name, professional title, and clinic/office address on it.
How long is the data kept in OARRS?
Two years
If a SLCP drug is a solid dosage form how must it be packaged?
Unit dose or two unit blister pack
How many delegates may one pharmacy have?
Unlimited
May a non-qualified pharmacy technician enter new prescriptions in the computer?
YES!
May a non-qualified pharmacy technician put away an order?
YES!
May a non-qualified pharmacy technician run a cash register?
YES!
May a non-qualified pharmacy technician select a unit dose medication and associate it with a label but not label the medication?
YES!
Starting March 1st may you partial fill a CII prescription?
YES! You may partial fill a prescription.
If a pain management clinic does not keep any drugs on site and doesnt personally furnish any meds to their patients, do they need a TDDD license?
YES. pain mgmt clinics are required to have a TDDD license even if no drugs are on site and the license must be signed by a physician.
Are MedGuides required for new prescriptions AND refills?
Yes
Must dispensaries report to OARRS?
Yes
Must psuedoephedrine and ephedrine sales be monitored?
Yes
Scenario: Mail order pharmacy located in Arizona, shipping Ambien to a patient in Ohio. Submit to OARRS?
Yes
A patient calls you because they forgot to pick up their child's Adderall prescription before they left for vacation. She would like to have it transferred to a pharmacy near her hotel. What do you tell her about this request?
You cant transfer a CII prescription. She would need her doctor to send a new prescription electronically to a pharmacy that is DEA certified if she wants to get it while she's on vacation.
There are 3 copies of the 222 form you fill out. Which copy do you keep and what happens to the others?
You keep copy 3 --> blue copy Copy 1 (green)& 2(brown) go to the wholesaler who then forwards copy 2(brown) to the DEA
What do you do if you do not receive the written "authorization of emergency dispensing" from the prescriber within 7 days of allowing them to call in an emergency supply of a C-II?
You must notify the nearest DEA field office
What is the 9th member of the BOP that is not a pharmacist?
a public representative that is at least 60 years old
You sign the DEA registration application for 4 locations but dont always want to be the one submitting the C2 order. Who may you grant power of attorney authority to?
any pharmacist (or ANY other person even not in the pharmacy)
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: Metamucil used as a laxative vs. used as dietary fiber
as laxative --> drug as dietary fiber --> supplement
How old do you have to be to be a pharmacist?
at least 18
How often must the patient meet face to face with the prescriber of diet medication?
every 30 days
For chronic weight management patients must meet face to face with their prescribers how often?
every 30 days for the first three months
JC is addicted to heroin and decides her wants to join an opioid treatment program (OTP). How often must he go there?
everyday. The longer you go and follow the rules the better your chances are of getting extended to week long supplies or stuff like that
A 222 form has 10 lines. What do you do if you need more than 10 items?
fill out another 222 form
What DEA form must you also fill out if there is theft or loss of a controlled substance?
form 106
If you run out of 222 forms what form do you need to fill out to order more?
form 222A
What form do you use if you need to report that you disposed of the spilled roxanol solution?
form 41
When are out of state TDDD required to obtain a TDDD license from the ohio BOP?
if at anytime they plan to deliver in ohio, even if it only 1 bottle
What constitutes a practice being considered a pain management clinic?
if more than 50% of the patients come in for pain mgmt. others ways to say this is that a majority of pts are being treated for pain or that a primary component of practice is treatment of pain
In what setting are pharmacists not required to offer counseling to patients?
in an institutional facility
Under the statute of limitations rule in negligence defenses, what is the statute of repose?
it limits the amount of time the pt has to "discover" an injury/damage caused by negligence. So the discovery rule protects the pt & after a while the statute of repose protects the pharmacist
2 important determinants of duty?
relationship & forseeability
If you dispense a medication that requires a med guide without one, you are guilty of __________
misbranding
If you sell drug samples (which say "not for sale" on them) you are guilty of ______________
misbranding
What are you guilty of if you sell a RX only medical device without a Rx?
misbranding
How does a dispensing pharmacy know the physician is DATA qualified?
must put an X number on Rx AND DEA #. (even though the X number is the DEA # with an X in front)
How many boxes may be checked on a preprinted prescription pad containing multiple noncontrolled substance options?
only 1 box and strength may be checked
What are the exceptions to the 7 day lapse period rule?
patient had an injury, prescriber is unavailable, patient was unavailable for valid reason, physician believes there was a valid reason they patient did not take it
Who may request for easy open caps?
patient's can request, prescribers can also but have to specifically request on every single prescription
May practitioners prescribe controlled substances to patients they interact with via the internet?
practitioners must have conducted at least one in person evaluation of the patient to prescribe a controlled substance. (Ryan Haight Online Pharmacy Consumer Protection Act of 2008)
The 5 members the BOP needs to vote is also called a ____________.
quorum
Under the statute of limitations rule in negligence defenses, what is the discovery rule?
stated that a cause of action time period that the plaintiff has to sue the defendant doesnt start to accrue until they have discovered the injury/damage. B/c many drugs effects may take months or years to notice.
What is vicarious liability under the doctrine of respondeat superior?
the employer is responsible for the negligent act of the employee
Rx only or OTC is determined by the FDA now but prior to the Durham-Humphrey amendment of 1951 it was determined by _______________________.
the manufacturer
The pharmacist in full and actual charge at all times at a pharmacy is know as what (in OH)?
the responsible person
As an intern, who determines what intern tasks you are allowed/competent enough to do during a shift?
the supervising pharmacist, so you may be allowed to do different tasks depending on what pharmacist is working
what is the purpose of vicarious liability under the doctrine of respondeat superior?
to cause employers to hire and train competent employees
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: E-cig solution containing nicotine
tobacco product, regulated by the FDA but not "drugs" so dont have to show safety and efficacy
It is now a physicians second year as a DATA qualifying physician and she managed 30pts last year. How many can she have this year?
up to 100
The DATA qualifying physician has now treated 100 pts for an entire year and is in her 3rd year of being DATA qualified. How many pts may she see?
up to 275
After the first three months of therapy how many refills may the physician provide the patient?
up to 5 refills in 6 months
When doesn't have to fill out a logbook or show identification for SLCPSs?
when a prescriptions written
What do you do if you make an error/typo while filling out your 222 form?
write VOID on form and keep on record
How do you document that you received the ordered C2 medications from the wholesaler?
write the date received on the 222 form in the "package shipped" line for every item you received
May a pharmacy disperse their C2's throughout the stock of non-controlled substances?
yes, they can disperse them or keep C2-C5s securely locked in "substantially constructed cabinet" (safe)
May a preceptor serve as a preceptor for more than 1 intern at a time?
yes, up to 2
Category 3 TDDD license means:
you can have any dangerous drug INCLUDING controlled substances
What is the maximum day supply allowed of medical marijuana to be dispensed?
90 day supply
What is the monthly sales limit of SLCPs?
9g
What expiration date is required for "medisets"?
< 60 days
How often does the responsible person have to be on site to be allowed to be the responsible person?
"a sufficient amount of time" to provide supervision and control of drugs, maintain all drug records required by state and federal law, & be responsible for the practice of pharmacy
There can be Class 1,2, or 3 recalls. What is a class 1 recall? do you have to get drug back from the pt?
"consumer level" -- most significant reasonable probability that the product will cause serious AE or death *must get drug back from the patient*
What is the "eggshell plaintiff" rule?
"requires defendants to accept whatever underlying condition the plaintiff had before the defendant's negligent act. A patient who is peculiarly susceptible to harm will not be penalized for that susceptibility. If the patient had a condition that predisposed the patient to harm from the pharmacist's conduct, the plaintiff is still compensated for the harm (even if most other people would not have been harmed in similar circumstances)"
There can be Class 1,2, or 3 recalls. What is a class 2 recall? do you have to get drug back from the pt?
"retail/Pharmacy level" may cause temporary or medically reversible AE's *do not have to get drug back from pt but must take it off your shelves
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: Duct tape -- marketed as adhesive but pt is using it to remove wart
"somehting else". Not marketed to be used to manage anything
There can be Class 1,2, or 3 recalls. What is a class 3 recall?
"wholesale level" product not likely to cause AE
A C-II prescription may not be faxed unless the patient falls under what 3 categories?
1. A resident of a long term care facility. (Not the same as assisted living facility) 2. A narcotic substance for a patient enrolled in hospice. 3. A compounded sterile product prescription for a narcotic substance.
What are the agreements called that let the prescribers lay out what the APNs and PAs may prescribe for them?
1. APN- standard care agreement 2. PA- supervision agreement
If there is any theft or significant loss of any dangerous drug or controlled substance it must be reported immediately to what 3 entities
1. BOP 2. Law enforcement authorities 3. the DEA **only if its a controlled substance**
Where must SLCPs be stored?
1. Behind the counter 2. In a locked cabinet
You receive a written prescription for a patient and they would like you to submit it to Ohio Medicaid for payment. It is not on a tamper-resistant prescription blank. What must you do?
1. Call prescriber and get confirmation that they did write it and document on prescription OR 2. Fill the prescription and obtain verbal confirmation within 72 hours
What are the 4 elements of negligence?
1. Duty 2. Breach of Duty 3. Causation 4. Damages
What 2 ways may a product recall be initiated?
1. FDA may require it 2. manufacturers may voluntarily self-initiate product recalls
What 4 entities does the BOP license?
1. Pharmacists 2. Pharmacy interns 3. TDDD (in and out of state) 4. Manufacturers and wholesalers of controlled substances
Starting in 2018 what are the categories pharmacy technicians will fall into when registering with the board of pharmacy?
1. Pharmacy Technician 2. Certified Pharmacy Technician 3. Pharmacy Technician Trainee
Which health care providers may obtain an OARRS report?
1. Prescriber or prescriber's delegate relating to a CURRENT patient 2. Pharmacist or pharmacist delegate relating to the practice of pharmacy involving the patient Also, law enforcement officers if warrant, grand jury pursuant to subpoena, coroners
What are the exceptions to the CV ephedrine classification?
1. Primatene 2. Bronkotabs 3. Dietary supplements that contain ephedrine
When you repackage tablets into unit dose packaging, what are the 2 acceptable way to note the place of business on the package?
1. The pharmacy name 2. The last 7 digits of pharmacy's TDDD license
What are the 6 required times an OARRS report must be run?
1. a patient adds a different or new controlled substance to their therapy 2. OARRS has not been reviewed for the patient in the preceding 12 months 3. A prescriber is located outside the usual pharmacy geographical area 4. A patient is from outside the usual pharmacy geographical area 5. A pharmacist has the reason to believe that the patient has received Rx for reported drugs for from more than one prescriber in the preceding three months (unless prescribers are in the same practice) 6. patient exhibits signs of potential drug abuse or diversion ** DOCUMENT THAT YOU REVIEWED THE OARRS REPORT **
What are the new activities technicians will be certified to do in 2018?
1. accept or request refill authorizations (not controls)
What are the 4 groups of exemptions from the federal anti-tampering act?
1. dermatologics (creams, sprays) 2. dentifrices (toothpaste) 3. Insulin 4. Lozenge type products
What 2 groups of prescribers are exempt from DEA registration to prescribe controlled substances?
1. employees of a hospital acting in the usual course of business. They use the hospitals DEA 2. officials of the US armed forces, public health service, or bureau of prisons. They use military ID as DEA
What are the technical functions that "qualified pharmacy technicians" may perform?
1. engage in compounding drugs 2. package or label drugs 3. prepare or mix IV drugs
5 facilities that are exempt from being classified as a "pain management clinic":
1. hospitals (or affiliated facility) 2. an educational institution (or affiliate) 3. facility affiliated with a medical or dental school 4. Hospice programs 5. Ambulatory surgical facilities
What 2 pieces of information must be placed on the package if it is too small to have a complete label on it?
1. prescription number 2. patient name
What type of sanctions will the board be able to do against certified technicians?
1. revoke/suspend licenses 2. place on probation 3. impose fine up to $500
What 3 things are you not allowed to change on a C-II prescription?
1. the drug prescribed 2. the patient name 3. the prescribers signature
What 2 ways may an impaired pharmacist seek help through PRO?
1. voluntarily seek help -- PRO wont tell BOP 2. ordered by BOP to seek help
What is the conversion from contact hours to C.E.Us?
10 contact hours = 1 C.E.U
If the responsible person changes to a new person, how many days does the new responsible person have to tell the BOP?
10 days
If a pharmacist provides a 30 day supply of a drug to a pt who is out of refills but has been filling it at their pharmacy regularly, this may only occur once in any ____________ time period per drug.
12 month
How long may a technician work before they are certified?
12 months
The total course of treatment with diet medication must not exceed how long?
12 weeks
How many days do patient's have to fill an opioid-containing drug prescription?
14 days
How old must the patient be to purchase SLCPs?
18 years old
How old must you be to be a technician?
18 years old
A bioequivalent generic must have a rate and extent of absorption within _____ to _____ % of the innovator drug
80 to 125%
How many members make up the BOP?
9
What is the mail-order limit of SLCPs?
30 day limit of 7.5g of SLCPs
Mrs. McCormick is out of refills and needs an emergency supply of Lantus, how many days can you legally give her?
30 day supply
Mrs. McCormick is out of refills and needs an emergency supply of metoprolol, how many days can you give her?
30 day supply
How many days do you have to send a copy of the form 106 to the BOP after submitting it to the DEA online?
30 days
How many days does a pharmacy intern have to file a statement of preceptor form with the BOP after beginning training?
30 days
What is the maximum day supply allowed on diet medication?
30 days
If a CII is partially filled how many days does the patient have to come back in a fill the remainder?
30 days (LTCF has 60 days)
An emergency C-II prescription is called into your pharmacy, you must receive a written authorization from the prescriber within how many days?
7 days
What is the maximum allowed interruption in therapy before the pharmacy can not fill and prescriber can not prescribe controlled weight loss medication?
7 days
What is the maximum days supply a PA may write a CII analgesics prescription for on an initial visit? What about subsequent visits?
7 days for initial visit. (Different from APNs who can write up to 14 days) No max after this initial visit (same as APNs)
If an adult other than the parent/guardian signs the consent form, what is the maximum days supply the prescriber may write for?
72 hours
How many of the members of the BOP are pharmacists?
8
How many years can you be a BOP member?
8, 4 year term but can be re-elected by the governor one time
What is the MED cut off considered for an increase risk of overdose?
>80 MED
In a pharmacy there must be personal supervision of the dangerous drugs by a pharmacist at all times. What must be in place whenever personal supervision is not provided by the pharmacist?
A physical or electronic barrier approved by the BOP (must be floor to true ceiling)
What are the two diet drugs FDA approved for CHRONIC weight management?
Belviq, Qsymia
Which of the following would require tamper evident packaging under the federal anti-tampering act? (select all that apply) a. Benedryl cream b. Halls menthol cough drops c. NyQuil liquicaps d. Hydrocortisone 1% spray e. Echinacea capsules f. Mouthwash
C & F only. C is an OTC drug. F would be considered a drug if it makes claims to fight gingivitis or cavities or would be a cosmetic if it is simply to freshen breath, either way it would be covered and require tamper evident packaging. A, B, & D are exemptions to the act and E is a dietary supplement which is not covered under the anti-tampering act.
What was the problem with contributory negligence that lead it to being replaced with comparative negligence defense stance in most jurisdictions?
Contributory negligent defenses if accepted were a complete bar to any recovery for the plaintiff. So the slightest negligence by that pt would make them lose the case even if the negligence by the pharmacist was much greater. Wasn't fair to the patients
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic, or something else: Under arm deodorant
Cosmetic (promotes attractiveness)
TRue/False: An APN may prescribe a 14 day supply for a C-II medication from a convenience care clinic, like a minute clinic/little clinic as long as the patient follows up with their doctor.
False, an APN cannot prescribe C-IIs from a convenience care clinic in any quantity.
True/False: The intern receiving a verbal prescription order is the only one responsible for initialing (positive identification) the prescription after they reduce it to writing from the phone call.
False, both the intern taking the order and the supervising pharmacist must have positive identification on the prescription because it is ultimately the pharmacists responsibility to assure validity and accuracy of the Rx
True/False: In Ohio, pharmacists cannot substitute interchangeable biosimilar products without prescriber intervention
False, law passed last December allows pharmacists to substitute interchangeable products (even though we hardly ever do this)
True/False: Biosimilar products means they are interchangeable
False, must be biosimilar to an approved FDA reference product AND meet additional standards for interchangeability.
True/False: If a prescriber retires but has already written prescriptions or refills for patients, those prescriptions and refills are still valid.
False, new Rx and refills on Rx's that you have on file are invalid if the prescriber retires
True/False: Unlike APNs, PAs must have their prescriptions cosigned by their supervising physician.
False, same as APNs, the supervising physicians name doesnt even need to be on the prescription
True/False: The supervising physician must be present in the office for their PA to see patients and prescribe for them
False, the PA must practice in the same office that their supervising physician practices in BUT the supervising physician does not have to present in the office at the same time.
True/False: All Rx drugs, OTCs, and dietary supplements are required by federal law to be uniquely identifiable with some sort of imprint so that along with shape, size, and color the active ingredients, strength, and manufacturer can be identified.
False, this regulation is only required for prescription drugs and OTCs, not dietary supplements
True/False: All RX and OTC drugs have to have an NDC number and it must be present on the label/package.
False. All Rx and OTC drugs must have an NDC number assigned to them but they are not required to be on the label/package
True/False: Pharmacists must provide counseling to patients whenever any prescription, new or refill, is dispensed
False. We must *offer* counseling but it is not required that we actually conduct the counseling.
Drugs are regulated from their production to dispensing to the patient. Federal laws primarily regulate __________ while state laws primarily regulate ______________________________.
Federal --> drug products State --> the practice of pharmacy
Name this act: 1. prohibited adulteration and misbranding of foods and drugs in interstate commerce 2. drugs must meet professed minimal standards of strength, quality, and purity 3. CAUSE: investigative reports from The Jungle & The Great American Fraud exposed food and drug adulteration problems
Federal Pure Food and Drug Act of 1906
Who regulates OTC advertising?
Federal trade commission (FTC)
Name this act: 1. Framework for todays Food, drug, cosmetic act 2. CAUSE: sulfanilamide elixir tragedy of 1937 3. No new drug can be marketed until proven safe by FDA, began approval process for drugs in USA
Food, Drug, and Cosmetic act of 1938
Do lapse in therapy rules apply to chronic weight management?
No
Does the BOP license pharmacy technicians?
No
Is the patient's BMI required to be on the prescription to be filled by the pharmacy?
No
May you diet medications in pregnant patients?
No
May you grow medical marijuana at home?
No
May you return medications to a central fill pharmacy once they have been delivered to the retail pharmacy?
No
May you smoke medical marijuana?
No
Must dispensaries employ a pharmacist?
No
Scenario: Fentanyl Patch filled for a nursing home patient. Submit to OARRS?
No
Do diet drug laws apply to OTC medications?
No (Alli)
Do diet drug laws apply to non-controlled medications?
No (Xenical, Contrave, Saxenda)
If the prescriber forgets to write the patient's name on a C-II prescription may you call the prescriber for verification and add the patient's name to the Rx?
No the patient must take it back to the prescriber
May a non-qualified pharmacy technician count 30 tablets to place in a vial?
No!
A pharmacy would like to open a clinic where patients may receive medical care for common, acute conditions. Could the pharmacy employee a PA to run the clinic?
No, a PA must practice in the same office as their supervising physician. (The clinic could employ an APN instead though)
If a pt has controlled substances that they no longer need, may a pharmacist allow the pt to return them?
No, a pharmacists or any DEA registrant may not physically take back/touch dangerous drugs/controlled substances from a pt bc it is now considered adulterated once the pt has it
Does a preceptor have to be a pharmacist to be a preceptor for a pharmacy intern?
No, as long as the board approves it first
If you spill half a bottle of roxanol solution on the floor do you need to report it as a loss?
No, bc you know what happened to it so it is not a loss. You must document it in the inventory records and dispose of it properly
RZ43 was approved by the FDA for hypertension. Further rat studies show that the drug also shows promise in lowering cholesterol. Can we add this as an indication?
No, because a new indication makes it a new drug.
Is an electronic alarm system on controlled substance storing systems required?
No, but it is recommended
May a practitioner self-prescribe or self-administer controlled substances?
No, it is illegal. You must have detached professional judgement to prescribe a controlled substance
does a prescriber need a TDDD license to legally prescribe medication in OH?
No. BUT if he plans to personally furnish pts with samples or give vaccines then yes
Is it illegal to prescribe or dispense against a black box warning?
No, its not breaking a law but can increase your chance of getting sued because you broke your duty to the patient because you should've known not to dispense against the BBW.
Do cosmetics have to list the amount of each ingredient in their product?
No, just lists them in order of prominence
Can a pharmacy have a drug take back day/program?
No, law enforcement agencies may though
In the state of Ohio, may a prescriber indicate that they do not want a drug substituted by writing "Do not substitute" on the prescription?
No, must hand write DAW or dispense as written
In the state of Ohio, may a prescriber indicate that they do not want a drug substituted by having 2 signature lines printed on their Rx pads - one line for substitution permissible and one line that indicates "dispense as written"?
No, must write DAW or dispense as written
Are miscounts or adjustments to inventory of controlled substances losses that need to be reported to DEA?
No, not considered to be significant
Do dietary supplement require tamper evident packaging under the federal anti-tampering act?
No, only OTC drugs, cosmetics, and devices
May pharmacy technicians receive oral prescriptions or phoned-in refill authorizations?
No, only pharmacists, pharmacy intern approved by pharmacist on duty, or recording device
If 2 products have the same drug name, strength, dosage form, and are both BC rated, are they interchangeable?
No, only products with the same 'A' rating (i.e AB, AP, AN) could be interchangeable.
If the theft or loss is a controlled substance can you inform the BOP, law enforcement, & DEA by telephone?
No, only the BOP and law enforcement can be phones, the DEA must written to
A prescriber indicates that he wants all prescriptions authorized by him for a particular patient to be in non-child resistant containers. Is this allowed?
No, only the patient may make a blanket request. The prescriber must make the request individually with every prescription.
An intern answers the phone and its a doctor wanting to give a verbal prescription. The pharmacist on duty stepped out to go to the bathroom, can the intern legally take the verbal order?
No, technically the pharmacist must be immediately available to answer any questions or discuss the prescription with the caller.
A physician decides to enter into a "Standard Care Agreement" with an APN. The physician does not have her own DEA# but the APN does. May the APN prescribe controlled substances listed on the APN formulary as "CTP holder may prescribe"?
No, the APN is subject to the same prescribing restrictions as the collaborating physician.
May a pharmacy's "Patient Education" printout replace a MedGuide?
No, the FDA approves MedGuides in a specific way and they cannot be replaced by other informative material
The Ohio APN Formulary states that APNs may not prescribe anabolic steroids. May a collaborative physician choose to allow her APN to prescribe anabolic steroids by stating so in their Standard Care Agreement?
No, the collaborating physician cannot trump what the APN formulary states the APN cannot prescribe. (The standard care agreement between the physician and APN can be *more* restrictive than the formulary though)
Does the OARRS delegate share an account with the pharmacist?
No, the delegate must have their own log in and account
The physician's nurse signed the physician's name and placed her initials after his signature to authorize 3 additional refills. Is this legally acceptable?
No, the prescriber must authorize the refills and the nurse cannot legally sign his name and indicate their initials after it.
You receive a Ritalin prescription written by a PA. The PA did not consult with the physician first before writing it and you filled it unknowingly. Are you liable in this situation?
No, there is a law in place that protects pharmacists from liability in these cases. We are not expected to know if the PA consulted with the physician or the physician already initiated it.
If a pharmacist misfills a prescription but that patient noticed before any medication was taken, can the pharmacist still be sued for damages that could have occurred?
No, there is no malpractice compensation if no actually harm was done
May you return medications un-used in medisets back to the stock bottle/shelf?
No, they are adulterated because they have touched other medications
Do vets need to utilize OARRS?
No, they are exempt
May physicians prescribe medical marijuana?
No, they may RECOMMEND it
If you have a DEA registration number and a nurse practitioner or PA is working under you and prescribing controlled substances, may they use your DEA#?
No, they need their own
May DEA registrants use collection receptacles to dispose of their controlled substance stock?
No, those are for patients only
As an intern, can you transfer out a Rx for Xanax?
No, under federal law interns can only transfer non-controlled substance Rx's
If a prescriber indicates "DAW" on a prescription but the patient requests the generic, may we legally perform the substitution?
No, we cant trump the prescribers DAW even if the patient wants generic
Can a prescriber with a valid DEA number call in a prescription for hydrocodone for his patient because he forgot to give him the hard copy earlier today at his appointment?
No. C-II prescriptions may NOT be transmitted orally unless they are for an emergency and ALL of the following conditions are met: 1. Must be immediately reduced to writing. 2. The quantity prescribed is sufficient for the emergency period only. 3. A written prescription ("Authorization for Emergency Dispensing")must be received from the prescriber within 7 days and attached to the emergency order
How many times may a prescription for a noncontrolled medication be transferred? What about a controlled substance?
Noncontrolled- for as many refills as there are (theres no limit as long as refills are available) Controlled- only once (unless the pharmacies have a real time online database, then allowed up to the number of refills prescribed)
Mrs. McCormick is out of Norco and needs an emergency supply, how many days can you give her?
None, unless the prescriber calls in an emergency supply and you get the hardcopy within 7 days
What does the Combat Methamphetamine Act of 2005 regulate?
OTC sale of Scheduled Listed Chemical Products (SLCP)
You have several bottle of C2 medications that are out of date and would like to send them to a reverse distributor for disposal. How must this transfer be documented?
On a 222 form where you, the pharmacist/pharmacy, are the supplier and they are the purchaser
If the patient fails to lose weight in the first 30 days how many times can they try again?
One more 30 day trial
Which medications is a DATA qualified prescriber allowed to prescribe for opioid detoxification/maintenance treatment?
Only C3-5 approved for tx of opioid addiction. Buprenorphine (Subutex) Buprenorphine/Naloxone (Suboxone)
If there is a prescriptions deposit box within the building where the pharmacy is located, who may access this box to retrieve the prescriptions?
Only a pharmacist
What must a prescriber do if an electronic prescription transmission fails and they print it out and give it to the patient?
The prescriber must include a notice that transmission was attempted and not successful to whatever pharmacy name on whatever date/time.
What must be recored for each sale of SLCPs?
Purchaser's name, signature, address, name and qty of product, date and time of purchase, type of govt issued identification provided at the time
The FDA's "____________ book" lists approved biological products with biosimilarity/interchangeability evaluations
Purple
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: No Salt sat substitute (KCl)
Special dietary food -- supplies dietary need but doesnt manage disease state
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: Splenda
Special dietary food -- supplies dietary need but doesnt manage disease state
Who is responsible if a pharmacy technician makes an error?
The pharmacist
What must a pharmacist do if they receive a prescription that has a notice from the prescriber stating that they tried to send the prescription electronically to whatever pharmacy but the transmission failed to go through?
The pharmacy that receives the prescription must verify that it was not filled from the transmitted version (Must contact the pharmacy the prescriber said they tried to send it to).
True/False: a drug of abuse is considered to be ANY controlled substance, ANY harmful intoxicant (fumes/vapor can be inhaled from), or ANY dangerous drug (so any drug since they are all "dangerous drugs")
True
True/False: bioequivalent drugs are also called therapeutically equivalent
True
True/False: if two drug products have the same 'A' rating, the FDA considers them to be therapeutically equivalent
True
Scenario: Phenobarbital for a canine filled at your pharmacy. Submit to OARRS?
Yes
Would you fill it?: An optometrist (OD) who prescribes Allegra®
Yes
Can the fax be cut into the size of a traditional prescription for storage purposes?
Yes - but only if the header information and the full name of the prescriber's agent that sent the fax is retained - the header is required for it to remain a valid prescription.
May a prescription issued by an out of state prescriber be dispensed in Ohio?
Yes, If the prescriber: 1. Has a license that is current and in good standing. 2. Prescription was issued while practicing in that state. (Follow Ohio's laws for prescribing scope, refills, expiration, etc.)
What if you did not dispense any controlled substances in a day, do you still have to report to OARRS?
Yes, Must submit a zero report
After 12 weeks therapy with Adipex-P may a patient start taking Qsymia?
Yes, Qsymia is for chronic weight management
May a prescription be transferred via fax?
Yes, as long as it has all of the information required for a verbal transfer
Would you fill it?: A dentist (DMD) who prescribes Xanax® for use before a dental procedure
Yes, as long as its a small amount just to calm them down before the procedure. (i.e. not 1T po TID prn)
May any pharmacy stock methadone and buprenorphine?
Yes, as long as they are DEA registered. **exception: cant get methadone 40mg unless they have an OTP waiver**
Can different states share Rx reporting system data?
Yes, as long as they are a participating state
A patient presents a prescription for lisinopril 20 mg 1 po daily #30 with 3 refills. He would like to receive a 90 day supply all at once to save money. May you dispense a 90 day supply?
Yes, as long as you contact the prescriber and get their approval first and document it on the prescription
Is prednisone considered a drug of abuse?
Yes, bc it is a "dangerous drug" and ANY dangerous drug is considered a drug of abuse
An MD prescribes tramadol to a minor. Is an informed consent required for this medication?
Yes, because this requirement is for all opioid containing products, not just C-IIs.
May you legally dispense an opioid containing product to a minor if you do not have the consent form?
Yes, if it is in the best interest of the patient the BOP says the lack of informed consent does not preclude us from dispensing the product to a minor
Can new or refill prescriptions be deposited by the pt when a pharmacist isnt present?
Yes, if there is a receptacle that is within the building where the pharmacy is located
Is there anyway a pharmacy can employ an individual that has had a felony relating to controlled substances?
Yes, if they request an exception/waiver and it is approved by the DEA BEFORE hiring the applicant
May you legally dispense a control to a patient that has an MED >80?
Yes, it is just a guide for practitioners
In the state of Ohio, if the prescriber writes "lisinopril" on a prescription may the pharmacist dispense the brand name (Zestril®) instead?
Yes, legally you can pick whatever you want because they wrote for the generic.
May a practitioner prescribe a noncontrolled substance to a family member?
Yes, not considered unethical to do this
May a prescriber issue a single prescription for > 30 day supply of a C-II?
Yes, there is no law against it. New this year opioid prescriptions may not exceed a 90 day supply.
Would you fill it?: A physician (MD) who prescribes antibiotic eye drops
Yes, they can prescribe anything as long as its for a human
If a baby is born with withdrawal symptoms bc the mother was an addict, can you give the baby opioids if necessary?
Yes, this is not considered addiction it is a disease state (neonatal abstinence syndrome)
As an intern, can you take a telephone Rx for Xanax?
Yes, you can legally receive oral controlled substance Rx's
As an intern, can you sell Robitussin-AC to a pt without a prescription?
Yes, you may legally dispense nonprescription C5's
Must the prescription number be the same between a central fill pharmacy and a retail pharmacy?
Yes.
If a product says 1% hydrocortisone but is only 0.5%, is it adulterated?
Yes. & also misbranded. b/c its strength, quality, pr purity is lower than listed on the label
Mrs. Gracie has only been a pharmacist for 3 days and is approached to be a preceptor for new intern, Emily. May Mrs. Gracie legally be Emily's preceptor in OH?
Yes. Anyone can be a preceptor in OH as long as their license is in good standing
If both the prescriber and the pharmacy have DEA certified transmission systems for electronic prescriptions, may a prescriber send over an e-script for hydrocodone?
Yes. As long as both systems are DEA certified, C-IIs may be transmitted electronically
May an intern log intern hours while working with a pharmacist that is not the preceptor they submitted to the BOP?
Yes. As long as its at the same site they submitted to the BOP
May an attending physician order methadone for a pt who comes in for appendicitis but starts experiencing withdrawal?
Yes. As long as the pt is there for something else and they are trying to maintain the addiction/avoid withdrawal. If pt comes in for addiction/withdrawal then no, must go to OTP
If a patient requests a medication's package insert are you legally allowed to give it to them?
Yes. But remind them that its not written at a level for the every day person
In a malpractice suit where a pharmacist has been proven to have a duty of care that has been breached, does the plaintiff still have to prove causation?
Yes. Even if a pharmacist owes a duty of care and that duty is breached, malpractice under the law requires proof that the pharmacist's misconduct caused the alleged damage.
Can a drug have an NDC number if it is not approved by the FDA?
Yes. Having an NDC number does not always mean it is approved by the FDA (Ex. grandfather drugs, medical foods, counterfeit drugs)
If a patient receives a patient package insert with their first fill of their birth control pills, do they have to also receive one with the refills?
Yes. It is required for new prescriptions and refills
A patient brings a prescription to the pharmacy for lorazepam 1 mg #60, one tablet twice daily as needed with 5 refills. The prescription was dated 11/01/14. The patient only wants to get 10 tablets at a time. The pharmacist dispensed 10 tablets originally and has partially refilled 10 tablets on 5 other occasions. The patient comes back and now wants 10 more tablets on 3/1/15. Can you dispense these 10 tablets?
Yes. The partial fills do not count towards the refill amount, the patient is still entitled to the full amount of tablets prescribed.
A prescriber writes for "Oxycontin 40mg tabs, take 1 po BID #60 (sixty)" You are out of 40mg tabs, after talking with the prescriber and getting approval, may you change the prescription to: "Oxycontin 20mg tablets, take 2 po BID #120 (one hundred twenty)"
Yes. You did not change the pt name, prescribers signature, or drug prescribed. You only changed the strength and quantity.
If your licensed in multiple states, can you use the same CE hours to fulfill requirements for both states? (double dipping)
Yes. for example, if you need 60 hours for OH but only 15 for KY, you can use 15 of your 60 OH hours and count them for KY. You would not need to do an extra 15 for 75 total.
Category 2 TDDD license means:
You can have any dangerous drug, except for controlled substances. (+single injection IV drugs from category 1)
What are the stipulations for "occasional sales" of drugs to other TDDD, wholesaler, or prescriber without being licensed as a wholesale distributor?
You cant sell more than 5% of the total value of all the drugs you bought that calendar year
What do you have to score on your NAPLEX & MPJE to be a licensed pharmacist
at least 75%
Must all pharmacists in the state of Ohio have an OARRS account?
all pharmacist who plan to dispense controlled substances within the state of Ohio
Why cant you use a DEA form 222 to order zolpidem?
bc 222 form is only for C1 and C2's
When in the drug approval process may the FDA require a REMS program?
before or after (anytime really)
A nonjudgmental error like misfilling would be considered which of the 4 elements of negligence?
breach of duty
What do advance practice nurses and physicians assistants have to get before they can legally prescribe?
certificate to prescribe (CTP) *CTP number must be on all prescriptions to be valid*
The commerce clause of the US constitution gives authority to regulate drug products to ____________ bc anything that crosses state lines cannot be controlled by only the state
congress
Food, Drug, Dietary supplement, special dietary food, medical food, device, cosmetic or something else: OraQuick at home HIV test
device
What drugs must be excluded from "medisets"?
drugs that must be dispensed in original containers, drugs incompatible with packaging, drugs incompatible when administered simultaneously, drugs that require special packaging
Explain adulteration as it applies to drug products
refers to its composition, mainly its strength, purity, and quality
Category 1 TDDD license means:
you can have single dose injections of IV drugs
How long do you have after a theft or loss to send your written notification to the DEA?
you must do this within 1 day