Pharmacy Jurisprudence
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 ALL of the drug back from ALL patients*
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)"
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 *Wholesaler/manufacturer makes drug unavailable to sellers*
What must you do every time you run an OARRS report?
** DOCUMENT THAT YOU REVIEWED THE OARRS REPORT **
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*
What is the limit for occasional wholesale sales before requiring to be licensed as a wholesaler?
- 5% of noncontrolled medication inventory - 5% of dosage units for controlled substances inventory
What are the CE requirements for OH pharmacists?
- 60 contact hours (= 6 C.E.Us) every 3 years - 3 of those hours in law - 2 of those hours in Pt or med safety
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)
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)
What are the C-IV drugs approved for weight loss?
- Adipex-P - Tenuate (diethylpropion) - Qsymia (phentermine/topiramate XR) - Belviq (lorcaserin)
Which controlled substances require an exact physical count (vs. an "estimated count")?
- All C-2's always - Any open controlled substance bottle with > 1000 dosage units in it - Exactly 1,000 and under are okay to estimate
what types of drugs can be donated to drug repositories?
- All drugs except controlled substances and drug samples - Must be in original sealed container
who may donate to charitable pharmacies?
- All that can donate to drug repository systems PLUS - Drug samples (only from manufacturer or prescriber)
Who may donate drugs to drug repository systems?
- Any that is a Terminal Distributor of Dangerous Drugs (has a TDDD license) - Wholesalers - Person it was legally dispensed to pursuant to a prescription order BUT IT CAN NOT EVER BE IN PATIENTS CUSTODY (hospitals or pharmacies can donate on their behalf)
What are the two diet drugs FDA approved for CHRONIC weight management?
- Belviq - Qsymia
How often must pharmacies submit data to OARRS? What about wholesalers?
- Daily for pharmacies and prescribers - Monthly for wholesalers
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
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
- Extra CE requirements - A monetary fine - Suspend your license - 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)
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* - It is okay to send electronic noncontrolled prescriptions to the pharmacies fax machine though
When 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)?
- 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.
What must you obtain to give vaccines?
- Immunization course - BLS training - Physician approved protocol
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
What is the "personal use exemption" for importation of controlled substances, regardless of the country?
- Limit 50 dosage units - In original prescription container - Must be declared on customs form
You received your daily dangerous drug order from your wholesaler, and now you need to file away the invoices for recordkeeping purposes. Your order included methadone, zolpidem and levothyroxine, among other drugs. How must these invoices be filed away? How long must they be kept?
- Methadone kept in file with 222 forms - Zolpidem and Levothyroxine (if on separate sheets) Zolpidem in C-III-V file and Levo with everything else - If not on separate sheets, can be placed together if there is an easy way to determine what is a controlled and what is not.
What are some drugs that do not have to follow the child-resistant containers rule?
- NTG - Topicals - Blisterpacks
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. - *BUTTTT* remember that patient package inserts (PPIs) still are required
Which of the following must have an actual physical count? Concerta® 54 mg tabs, 100 count bottle Ambien® 10 mg tabs, 100 count bottle Codeine/acetaminophen 30/300 mg tabs, 1000 count bottle
- Only the concerta = CII are always hard counted - Ambien < 1000 = can be estimated - Codeine/APAP is 1000 (or less) so it can be estimated
Pharmacists may do what under a consult agreement?
- Order blood tests & interpret - Change medications - Administer medications
What are the exceptions to the 7 day lapse period rule for weight loss meds?
- Patient had an injury - Prescriber was unavailable - Patient was unavailable for valid reason - Physician believes there was a valid reason the patient did not take it
Institutional Pharmacy: What must a nurse document when removing controlled substances out of a medication cart?
- Patient name - Quantity - Proof of use - Time and date
who can participate in drug repository systems?
- Pharmacy - Hospital - Non-profit clinic with TDDD
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 - Azo
Duties of a "Clerk"
- Pricing - Cashier - Delivery - Inventory - *Document* (only) third party reimbursement May NOT enter any info into the computer
What must be recorded 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
what are the options for offering low cost or free medications to patients in Ohio?
- Register as a stand alone charitable pharmacy - Register as a regular pharmacy and participate in drug repository system
A black boxed warning is required when use may lead to death, ___________________, or ______________________________________________________
- Serious injury - Collateral measures need to be taken for safe use
what qualifies a pharmacy as charitable?
- TDDD - Not for profit - Can not be a hospital
outsourcing facilities must be registered with __________ & __________
- The FDA, as an outsourcing facility - Ohio BoP, as a wholesaler distributor of dangerous drugs with an outsourcing facility classification
When a pharmacist takes a verbal prescription they must reduce it to writing immediately and include what information?
- The full name of the prescriber - The full name of the prescriber's agent/caller - Positive identification of the pharmacist who took the order
What are the 3Ts that must be on file with track and trace
- Transaction info - Transaction history - Transaction statement
One busy Monday morning your electric goes out and you cannot access your computer system. Several patients come in for refills. One of the patients really needs his refills now because he is on his way out of town. What may you legally do?
- Use professional judgement on whether refill is still available - Must pull original prescription and document on the back that you refilled it and then enter it in the computer when electric returns.
A BOP inspector comes to your pharmacy and would like you to show her the hardcopy of a prescription that was filled by your pharmacy 2 years ago. When must you provide this to her?
- Within 3 business days (because it's 2 years ago) - If within 1 year it must be produced immediately
Institutional Pharmacy: How can orders be transmitted to institutional pharmacies?
- Written - Orally - Fax - Electronic system
Can the fax be cut into the size of a traditional prescription for storage purposes?
- Yes, 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 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.
You cannot compound products for a pick up station outside a pharmacy unless stipulations are followed. Name some of these.
-- The site is appropriately licensed (as a TDDD) -- Receipt, storage, control, and distribution of prescriptions/drugs are in the full and actual charge of a health care professional -- An appropriate recordkeeping system is in place that will provide accountability for proper receipt, delivery, and return of all prescription medications -- Counseling is offered -- There is clear and convincing evidence that delivery of prescription medication directly to the patient would result in: i.) Danger to public health or safety ii.)Danger to patient without increased involvement by a health care professional
What information must be documented in the bound record book?
-Name and address of purchaser -Signature of the purchaser -Name and quantity of controlled substance sold -Date of sale -Name and legible initials of the RPh/Pharmacy Intern who sold the product
How many controlled substances may be on the same prescription?
1
DEA # calculation
1 + 3 + 5 = a 2 x (2 + 4 + 6) = b a + b = cd D must be last # of DEA #
Institutional Pharmacy: How many days' supply does a patient pay for at a time as a skilled patient?
1 day at a time, compliance packaging
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.
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 is the agreement called that lets the prescribers lay out what the APNs can prescribe? What about for the PAs?
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 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 type of transactions get reported to OARRS?
1. Outpatient dispensing 2. Personal furnishing (MD offices) 3. Wholesale Sales
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 C-V ephedrine classification?
1. Primatene 2. Bronkotabs 3. Dietary supplements that contain ephedrine
What 3 things are you not allowed to change on a C-II prescription?
1. The *Name* of the drug prescribed 2. The *Name* of the patient 3. The prescribers signature (prescriber's *Name*)
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 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 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 drugs are included in SLCP?
1. psuedoephedrine 2. ephedrine 3. phenylpropanolamine (not used anymore)
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 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
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
If a pharmacy decides to close they must inform the board through written notice in how many days?
14 days
How many days do patient's have to fill an opioid-containing drug prescription?
14 days from written date or "do not dispense until" date
Above what quantity of sodium will the labeling of a nonprescription drug need the following warning statement "Ask a doctor before use if you have a sodium restricted diet"?
140 mg
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 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
Transactions through CSOS must be reported to the DEA within how many days?
2
Institutional Pharmacy: At minimum what is required when nursing needs into a closed pharmacy for emergency medications?
2 employees, one must be a registered nurse, a record of what happen
How long are consult agreements good for?
2 years
According to the DEA how long must prescription records for controlled substances be kept? What about Ohio?
2 years according to the DEA 3 years for Ohio
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 ****
What can a certified technician do that a registered or trainee tech cannot?
2018: - Accept verbal rx orders - Sterile compound - Accept refill requests - Receive transfers
What documentation is required for a partial fill of a C-II prescription?
2018: - Date dispensed - Qty dispensed - Remaining qty on rx - Rx # of partial fill (if different than remainder) - Positive identification of pharmacist
Tech Trainee Requirements
2018: - Must be 18 years old - High school diploma (or equivalent) or employed as a tech prior to 4/8/09 - Background check - Trainee registration is valid for 1 year, and cannot be renewed
New Ohio Opioid Restrictions
2018: - Must be filled with in 14 days - 90 day Max - ICD-10 code - Day supply must be included on Rx
Midlevel practitioners and suboxone
2018: - NP and PA may apply for DATA-waiver (x-DEA #) - Includes buprenoprhine now in Ohio - Limited to 30 patients at one time - Supervising physician must also have DATA-waiver
Controlled substance disposal
2018: - No longer need permission to dispose of (no longer need DEA Form 41) - Can use reverse distributor (DEA form 222) or - Onsite "non-retrievable" method - Keep forms with other DEA forms
What cannot be changed on an opioid prescription?
2018: - Patient name - Drug name - Prescriber name
Any pharmacy performing MTM services must have:
2018: - TDDD category II limited (if not a dispensing pharmacy) - TDDD (of the dispensing pharmacy) - Must be maintained for 3 years
How long do you have to notify the board of a change in: Responsible person
2018: 10 days
How long must pharmacy records be kept for?
2018: 3 years
TDDD License Renewal
2018: 3/31
How long do you have to notify the board of a change in: Name Address Place of employment
2018: 30 days
Max day supply of an opioid if prescribed by an optomotrist
2018: 4 days Only can prescribe codeine/hydrocodone products
How long do you have to get a new written prescription after an emergency fill?
2018: 7 days
How long do you have to notify the board if: No longer an intern or in a school of pharmacy
2018: 72 hours
What is an Outsourcing Facility?
2018: Facility at one geographic location or address that: - Is engaged in the compounding of drugs - Has elected to register as an outsourcing facility - Complies with all of the requirements of section 503B (Compounding Quality Act)
Can you dispose of a patient's old medications at a community pharmacy?
2018: No Considered adulterated
Certified Technician Requirements
2018: Same as registered tech plus: Certification by: - PTCB or -ExCPT
Registered Tech Requirements
2018: Same as trainee plus: - Complete training program by: - ASHP - Armed forces - Employer based - Must be 160 didactic hours - 320 practical experience hours - Pass a 100 question minimum exam (passing >70%)
Pharmacist and Intern License Renewal Date
2018: September 15
Can a registered tech do non-sterile compounding?
2018: Yes, if they complete on site training
Compounding Quality Act (Section 503B)
2018: - Defines what an outsourcing facility is Products from an outsourcing facility may qualify for exemptions from: - Drug approval requirements of FDCA section (approval of new drugs) - Requirements for adequate directions for use - Track and trace requirements
Biosimilar vs. Interchangeable
2018: - If an interchangeable product is available, regardless of whether a substitution is made, the RPh must communicate to the prescriber which specific product was dispensed within 5 business days - Must include name of drug and manufacturer (Currently there are no available interchangeable products in the U.S.)
When can an RPh administer an injectable drug?
2018: - If they completed a course in administration of drugs that meets BoP criteria - Must maintain CPR training Physician-established protocol - May administer drugs prescribed by additional physicians, not just the physician who signed the protocol
Requirements of outsourcing facilities
2018: - Must comply with cGMP requirements - Inspected by FDA - Must provide FDA with info regarding products compounded - Must report adverse events - Not required to be a licensed pharmacy (no TDDD) but must have direct pharmacist supervision - Must also be licensed as a "wholesaler" with an outsourcing facility classification
Long Term Care Drug Disposal (RPh disposal)
2018: - RPh and supervisory level nurse may destroy together using on-site method - Not required to be "non-retrievable" method, but must be "unavailable and unusable" Record keeping: - Date of destruction - Patient name - Drug name/strength/qty - Method of destruction - Positive ID of RPh and nurse
Long Term Care Drug Disposal (Nurse Disposal)
2018: - Upon discontinuation of medication, must be removed from medication cart and securely stored for disposal *within 10 days* Must document: - Date - Patient name - Drug name/strength/qty - Positive ID of 2 nurses who removed med
Expedited Partner Therapy
2018: Can ONLY be employed for: - Chlamydia - Gonorrhea - Trichomoniasis -Max of 2 partners per patient - Use partner's name or "EPT" as name on Rx
Which injectable meds can be administered by an RPh?
2018: If prescribed by a physician: - Opioid antagonist for drug addiction in LA/ER form - LA/ER antipsychotics (Abilify) - *Hydroxy*progesterone caproate for pregnant women - *Medroxy*progesterone acetate for *non*-pregnant women - Cobalamins (Any FDA approved B12 injection)
Which DEA form is used for registration with the DEA?
224
Intern:Pharmacist Ratio
2:1
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 records be kept pertaining to immunizations?
3 years
How long must you keep records of disposals?
3 years
Institutional Pharmacy: How long must records be kept?
3 years
How long shall all other records pertaining to the practice of pharmacy be maintained for?
3 yrs
how long do you have to keep rx files on file?
3 yrs
Above what quantity of calcium will the labeling of a nonprescription drug need the following warning statement: "Ask a doctor before use if you have: -Kidney stones - A calcium-restricted diet"
3.2 grams
What is the daily sales limit of SLCPs?
3.6g
Annual TDDD license is renewed on:
3/31
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 name?
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 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
How many days do you have to inform the physician or board of health after administering vaccines?
30 days (don't have to report influenza in patients >18 yo)
What is the maximum day supply allowed in "medisets"?
31 days
How much Robitussin AC may a patient receive as an "exempt narcotic" without a prescription?
4 ounces every 48 hours
Term Length and # of Terms for a BoP member
4 year terms Max of 2 terms
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
DEA registration renewal notices are sent how much time in advance before expiration?
60 days
How many semesters hours of college must you complete before you can be a pharmacy intern?
60. (90 quarter hours)
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
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
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
BoP Members
9 members 8 pharmacists 5 members present for a quorum
What is the maximum day supply allowed of medical marijuana to be dispensed?
90 day supply
Above what quantity of potassium will the labeling of a nonprescription drug need the following warning statement: "Ask a doctor before use if you have: -Kidney stones - A potassium-restricted diet"
975 mg
What is the monthly sales limit of SLCPs?
9g
What expiration date is required for "medisets"?
< 60 days
how long of an expiration must donated drugs have?
> 6 months
What is the MED cut off considered for an increase risk of overdose?
>80 MED
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
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)
Non-mid-level practitioner's DEA numbers start with what letter(s)?
A, B or F
How long are the following prescriptions good for from the date written? A. Non-controlled B. C-V C. C-II, C-III, or IV
A. 1 year B. 1 year C. 6 months, or 14 days if opioid rx
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
A. 6 months B. 6 months C. 6 months D. Within 14 days from date written or 'do not fill before' date
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
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
James goes to his PCP to face his drug addiction. He does not have DATA-waiver. What can he do while James waits to join an OTP?
Admin a single dose of buprenorphine product per day for a max of 3 days
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?
After 3 years you must retake the exam to get your license back
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
A pharmacy would like to open a clinic where patients may receive medical care for common, acute conditions. Should the pharmacy employ a PA or an APN to run the clinic?
An APN, because a PA must practice in the same office as their supervising physician.
How often must an immunization protocol be reviewed?
Annual
How often must "self certification" to sell SLCPs be renewed?
Annually
What immunizations can you administer to patients 7-13 yo without a prescription?
Any immunization indicated by CDC
What immunizations can you administer to patients >13 yo without a prescription?
Any immunizations indicated by CDC
What immunizations can you administer as an intern?
Any that a pharmacist can give (we must stay CPR certified)
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 C-III 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
Vicodin Tussionex Demerol What schedule of drugs are these?
C-II
Phenobarbital is what class schedule?
C-IV
How does Ohio classify ephedrine containing products?
C-V
Mrs. Smith pays cash for all of her prescriptions. A friend has recently informed her that she can buy her medicines online from a Canadian pharmacy and save a lot of money. As Mrs. Smith's pharmacist, she asks for your advice on purchasing her drugs from Canada. What would be the best information to provide? A. Inform Mrs. Smith that the FDA does allow limited quantities of prescription drugs to be purchased online from different countries and that she could safely buy her current medications from any country, including Canada. B. Inform Mrs. Smith that buying medications only from Canada, but not other countries, is legal under the FDCA. C. Inform Mrs. Smith that she is only allowed to purchase her medications in the United States, and assist her in finding alternative ways to save money. D. Inform Mrs. Smith that Canadian pharmacies are only permitted to fill maintenance medications; therefore, she will be limited in what drugs she can purchase over the internet.
C. Inform Mrs. Smith that she is only allowed to purchase her medications in the United States, and assist her in finding alternative ways to save money.
An e-rx prints out and contains a diclofenac, ambien, and prednisone. what Rx file does it get filed in?
CIII-CIV, bc its a CIV
There are 3 prescription files kept at the pharmacy, which one would a provigil hardcopy go in?
CIII-V bc its a CIV
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
What is an outsourcing facility?
Compound and provide non-patient specific products for Drs office use
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
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)
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
Institutional Pharmacy: how often must reconciliation of controlled medications happen?
EVERY shift change with leaving and arriving healthcare professional
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: 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: Hazardous drugs must be in a *positive* pressure environment
False, negative pressure environment
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: Pharmacist only have to conduct a prospective drug utilization review (DUR) on new prescriptions.
False, new and refill prescriptions require a DUR
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 not required for dietary supplements, it is required for Rx drugs and OTC drugs
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 *food*s and drugs in interstate commerce 2. drugs must meet professed minimal standards of strength, quality, and *pur*ity 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
When can you partial fill a C-II?
For any patient if: - Requested by patient/prescriber - Total qty dispensed cannot exceed total written qty - Remaining amount must be filled within 30 days of *written* date - Must fill whole Rx at same pharmacy
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
The district pharmacy manager would like you to send your inventory records to the corporate office for safekeeping. May you do this?
If approved by the BoP in writing
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.
When can an advance practice nurse prescribe C-II stimulants approved for ADHD?
If they have a formal established diagnosis from the MD or they talked to the MD first before prescribing it
A patient presents a new 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?
If you contact the prescriber and get their approval first if this is a NEW drug for the patient and document it on the prescription, then yes
Name this act: 1. first federal statute to protect us from harmful drugs 2. prohibited *import*ation 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
Institutional Pharmacy: How must contingency supplies be stored?
In a locked cabinet outside of the institutional pharmacy
What immunization can you administer to patients >7 years without a prescription?
Influenza
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
Institutional Pharmacy: A patient would like to keep his albuterol inhaler at the bedside, how is this allowed?
Label the med as an outpatient prescription
May a practitioner self-prescribe or self-administer noncontrolled substances?
Legally yes, but the board of medicine sees this as unethical.
According to the Controlled Substances Act, which of the following drugs is NOT required to have the following warning on the container when dispensed: "CAUTION: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed'?
Lyrica
Mid-level practitioner's DEA numbers start with what letter?
M
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 C-II 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
A written prescription is required to have a phone number printed on it where a prescriber can be reached during normal business hours and what else?
Must also have: - The prescribers full name - Professional title - Clinic/office address
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)
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 must be approved by the FDA before we may legally distribute the "new drug" in interstate commerce for patient use?
New drug application (NDA)
A patient no longer needs to use insulin and he has many insulin syringes left over. May he sell or give his syringes to someone else?
No
Are qualified technicians certified by the board of pharmacy?
No
Consult Case: May you adjust the glyburide therapy that a physician outside of the group practice initiated?
No
Do SLCPs have to be kept in a pharmacy?
No
Do cosmetics required FDA approval?
No
Do lapse in therapy rules apply to chronic weight management?
No
Does a pharmacist have to prepare the products at an outsourcing facility?
No
Does the BOP license pharmacy technicians?
No
Is a logbook required for sale of syringes?
No
Is the patient's BMI required to be on the prescription to be filled by the pharmacy?
No
May a local pharmacy compound products for local physicians to use "for office use"?
No
May a pharmacist administer a MMR to a child <7 years old?
No
May a pharmacist manage medications of a patient under a consult agreement with physicians not in the agreement?
No
May pharmacies compound drugs and sell them to another pharmacy?
No
May pharmacists compound medications for physicians to use in their offices?
No
May pharmacists compound products for OTC sale? What if all the components are OTC medications?
No
May the pharmacist serving as the "agent" order controlled medications?
No
May you dispense 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
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!
Sally, an intern, is ready to give vaccines with all required tasks completed. Her pharmacist does not have all required tasks completed. Can Sally intern administer vaccines?
No!
do ads for OTC meds require true statement and fair balance?
No, FTC regulates OTC not FDA.
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
Are drugs compounded by outsourcing facilities FDA-approved?
No, dont go through NDA process
Pharmacist phil got his immunization training in 2003, may he administer HPV vaccine?
No, he needs approved CE since the vaccine came out after his training
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
Your pharmacy stocks guaifenesin 100 mg/codeine 10 mg per 5 mL syrup in 1 pint bottles. May you pour 2-4 ounces in a prescription bottle and sell it to a patient as an "exempt narcotic"?
No, it must have the full drug facts information with it
Is it illegal to prescribe or dispense against a black box warning?
No, its not breaking a law (BBWs are just guidelines) 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.
Does the controlled substance inventory need to be submitted to the DEA or Ohio BOP?
No, just keep it on file in case they want/need to see it
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
Can you use a 3 ring binder/notebook for your exempt narcotic record book?
No, must be bound
May you advertise that you sell syringes without a prescription?
No, must be kept out of sight of general public and out of their reach
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
An outsourcing facility would like to also compound patient-specific prescriptions. May it do this?
No, must have a TDDD license and must have RPh on duty to check it
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
Institutional Pharmacy: After the patient was given alteplase, he needs to be admitted for observation. He needs his maintenance medications and the pharmacy is closed. May the nursing staff go into the pharmacy?
No, not urgent need
Scenario: Fentanyl Patch filled for a nursing home patient. Submit to OARRS?
No, nursing home patient
A retired pharmacist decides to open an old-time soda fountain and calls it "The Olde Apothecary Soda Fountain". Is this allowed?
No, only a pharmacy licensed as a TDDD or licensed pharmacist may display a sign advertising 'apothecary' in it
A person that sells dried herbs and extracts opens a flea market booth and calls it "Nature's Pharmacy". Is this allowed?
No, only a pharmacy licensed as a TDDD or licensed pharmacist may display a sign advertising 'pharmacy' in it
May pharmacy interns administer epinephrine in an anaphylactic situation?
No, only pharmacists
May pharmacy technicians receive oral prescriptions or phoned-in refill authorizations?
No, only pharmacists, pharmacy intern approved by pharmacist on duty, or recording device
May a PA enter into a consult agreement with an RPh?
No, only physicians
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 phoned, the DEA must be 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.
Do dietary supplement require tamper evident packaging under the federal anti-tampering act?
No, only: - OTC drugs - Cosmetics - Devices Require tamper evident
May you sell Phenergan® with Codeine (promethazine + codeine) syrup as an exempt narcotic without a prescription? (It contains 10 mg of codeine per 5 mL)
No, promethazine is an Rx drug
You dispense ~ 10 compounded progesterone cream prescriptions per month (4 oz each). May you prepare 5 lbs of the cream in advance?
No, thats double the amount you would need to fulfill those prescriptions
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 actual 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
Does the pt have to show you their ID when purchasing codeine products over the counter?
No, unless they are unknown to you
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
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
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.
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.
does the FTC look at OTC ads before they are publishes/aired?
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
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
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
Institutional Pharmacy: What medications can be sent home with LTC patients upon discharge?
Non-"unit dose" things: - Inhalers - Nebulizers - Enoxaparin
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)
The "exempt narcotic law" in Ohio also mentions C-V opium-containing products in solid or liquid form. Which of these may I sell without a prescription?
None
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
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
Nyquil liquicaps and Mouthwash - Nyquil is an OTC drug. - Mouthwash 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. - Benadryl cream, Halls menthol cough drops, & hydrocortisone 1% spray are exemptions to the act - Echinacea capsules are a dietary supplement which is not covered under the anti-tampering act.
What does the Combat Methamphetamine Act of 2005 regulate?
OTC sale of Scheduled Listed Chemical Products (SLCP)
What does OARRS stand for?
Ohio Automated Rx Reporting System
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 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
Institutional Pharmacy: When med cart controlled substance counts are off who must be notified?
Pharmacy director, supervisor
Patients must have an on going relationship with who in a consult agreement?
Physician
What is required for immunizations given to patients <18 years old?
Positive identification from parent/guardian
How can a patient still get multiple CII prescriptions written at a time, while still following 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 (direct to consumer)
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
The FDA's "____________ book" lists approved biological products with biosimilarity/interchangeability evaluations
Purple
Explain adulteration as it applies to drug products
Refers to its composition. Mainly its: - Strength - Purity - Quality
What schedule is a codeine 15 mg tablet?
Schedule II
Codeine and guaifenesin together makes a drug what schedule?
Schedule III
Cough syrup with: Dihydrocodeine bitartrate 7.5 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg/5 ml What schedule is this drug?
Schedule III
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
Scenario: Gabapentin dispensed at VA outpatient pharmacy. Submit to OARRS?
They are not required by law, but most typically do.
Institutional Pharmacy: How must long term care facilities dispose of un-used medications?
They can have a take back box, most throw them down the toilet
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
Under federal law, how long are C-II rx's good for?
They do not expire
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.
You notice that your inventory of Demerol® 50 mg tablets #500 count is off by 4 bottles. What do you do?
This is a significant loss so you must: - Call BoP immediately - Write to business department of the DEA within 1 business day - Fill out the DEA 106 form
When would you file a DEA 3911?
To investigate and quarantine "suspect" or illegitimate products
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.
The immunization protocol must be available at all times to be immediately given to the BOP. T or F?
True
The protocol must include the time required to observe patients for adverse effects, T or F?
True
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: A password alone is never sufficient as a positive identification method
True
True/False: Any prescriber office which accepts compounded products or compounds their own products, must be registered as a TDDD in Ohio.
True
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: 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
True/False: hazardous drugs must always be separated from non-HD
True, if they are in active powder form
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: 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
How long is the data kept in OARRS?
Two years
How can a pharmacy intern administer vaccines?
Under direct supervision of the pharmacist
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
When can a prescriber call in an emergency fill for a C-II medication?
When 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
When does the DEA require pharmacies to perform drug inventory of controlled substances?
When the pharmacy first opens and When a new drug becomes controlled
When must controlled substance inventory be taken?
Whenever the PIC or responsible person changes and at least once every calendar year
If a CII is partially filled, when must the patient come back in and fill the remainder?
Within 30 days (LTCF has 60 days)
How many refills can the following drugs have: Xyrem Halcion Ultram
Xyrem (C-III) - 5 refills Halcion (C-IV) - 5 refills Ultram (C-IV) - 5 refills
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.
After learning this, may the physician fax the prescriptions to you, you compound them, and then have them delivered to the physician's office for pick-up by the pt?
Yes
Are MedGuides required for new prescriptions AND refills?
Yes
Consult Case: May you adjust antihypertensive therapy?
Yes
Consult Case: May you change oral medications to insulin?
Yes
Consult Case: May you order a BMP to evaluate the patients renal function?
Yes
May pharmacists and pharmacy interns fit for diabetic shoes?
Yes
Must dispensaries report to OARRS?
Yes
Must psuedoephedrine and ephedrine sales be monitored?
Yes
Would you fill it?: An optometrist (OD) who prescribes Allegra®
Yes
A local physician specializes in hormone replacement therapy for men and women and would like patients to receive their compounded prescriptions at her office. You work at a community pharmacy. May the physician fax the prescriptions to you, you compound them, and then have them delivered to the physician's office for pick-up by the patient?
Yes because you are making it for an individualized patient...considered a "prescription pick-up station"
Can pts import meds from canada?
Yes if: - Its no more than 90 days supply - FDA approved (cannot be controlled or biological) - Must be in the original dispensed package
May a pharmacist administer the rabies vaccine?
Yes prophylactically Not for treatment after bite
A patient needs a prescription switched from metoprolol 6.25 to 12.5 BID. May the pharmacist change the order under a consult agreement?
Yes they can do one of the following: - Rph as the prescriber - Rph as the "agent" of the prescriber
Who may you sell syringes to? a.) Person who makes miniature action figures as a hobby and often needs to very carefully attach weapons to them with glue. b.) Farmer who administers intramuscular antibiotics to his livestock c.) Patient from out of town who uses insulin and forgot to bring her syringes with her
Yes to all
May pharmacists order controlled substances in a collaborative agreement? If yes, what must they get?
Yes, IF they get: - A prescriber consult registration to the BOP AND - The DEA registration (must let the board know within 5 days when no longer authorized to prescribe)
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 of 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
Is prednisone considered a drug of abuse?
Yes, bc it is a "dangerous drug" and ANY dangerous drug is considered a drug of abuse
Do pharmacies that occasionally compound products for prescribers (sterile or nonsterile) to use in their offices need to register as outsourcing facilities?
Yes, because they are for a Dr. office
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 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
Institutional Pharmacy: May someone from the ED enter the hospital pharmacy to obtain alteplase?
Yes, if - It is an immediate concern - Two people need to enter, one has to be a licensed nurse
Patient comes to your pharmacy to fill for Percocet and hasn't filled for a controlled substance in over a year, do you have to run an OARRS report?
Yes, if OARRS has not been reviewed for the patient in the preceding 12 months
If a patient is getting an additional/new controlled substance to their therapy, do you need to run an OARRS report?
Yes, if a patient adds a different or new controlled substance to their therapy
A patient who is acting "sketchy", rushing you, very agitated and seems to be exhibiting some signs of withdrawal while they are waiting for you to fill their controlled substance prescription. Do you have to run an OARRS report?
Yes, if a patient exhibits signs of potential drug abuse or diversion
A new patient who just moved to your area comes in to fill a controlled substance. Do you have to run an OARRS report?
Yes, if a patient is from outside the usual pharmacy geographical area
You are reviewing a patient's profile who you are filling a controlled substance prescription for. You notice that they are have been to multiple different doctors in the last 3 months (all different practice sites) for controlled substances. Do you have to run an OARRS report?
Yes, if a pharmacist has the reason to believe that the patient has received Rx for reported drugs from more than one prescriber in the preceding three months (unless prescribers are in the same practice)
A patient comes to your pharmacy to fill a controlled substance from a doctor from out-of-state. Do you have to run an OARRS report?
Yes, if a prescriber is located outside the usual pharmacy geographical area
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.
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.
Institutional Pharmacy: must the staff document their visit?
Yes, names, date, time, drug, etc.
May a practitioner prescribe a noncontrolled substance to a family member?
Yes, not considered unethical to do this
Scenario: Phenobarbital for a canine filled at your pharmacy. Submit to OARRS?
Yes, outpatient dispensing
Scenario: Mail order pharmacy located in Arizona, shipping Ambien to a patient in Ohio. Submit to OARRS?
Yes, patient in Ohio
Would you fill it?: A physician (MD) who prescribes antibiotic eye drops
Yes, they can prescribe anything as long as its for a human
Institutional Pharmacy: may dangerous drugs be stored on the patient floors of an institution?
Yes, think pyxis and medication carts (locked, positive identification, etc.)
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)
May a pharmacist provide a 30 day supply of a drug to a pt who is out of refills but has been filling it at their pharmacy regularly? If so, how many times can this occur?
Yes, this may only occur once in any 12 month time period per drug
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, or 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
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 blue copy) You give green and brown copies to the wholesaler The wholesaler gives green copy to the DEA and keeps brown copy
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
The 9th member of the BOP that is not a pharmacist is a ________ and must be _________?
a public representative that is at least 60 years old
Which of the following may you sell Robitussin AC® to? a.) 21 year old with dry, hacking cough b.) 68 year old who would like to use it "for sleep" c.) 16 year old with cough that inhibits functioning at work (telemarketer)
a. yes b. no, not a legitimate medical purpose c. no, must be > 18
Are you required to provide transaction information/history as a supplier for the following: a.)Neighboring pharmacy (not under common ownership) would like to purchase 3 albuterol inhalers from you because they are out of stock. b.) Neighboring pharmacy (not under common ownership) would like to purchase 30 atorvastatin 20 mg tablets from you because they are out of stock and have a patient with a prescription who needs them. c.) another independent pharmacy under common ownership with you would like to transfer 3 albuterol inhalers from you because they are out of stock
a.) yes b.) no, becuase its for an identified pt's need c.) no, because its under common ownership
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
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
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
What do you have to score on your NAPLEX & MPJE to be a licensed pharmacist
at least 75%
Institutional Pharmacy: what is required for an inpatient prescription?
basically everything you would think would be required ... don't need patients address or anything
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*
who may fill at charitable pharmacies?
charitable pharmacies can determine eligibility requirements, may not have dispensing fee
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
Institutional Pharmacy: what is contingency supply?
drugs which may be required to meet the therapeutic needs of patients when a pharmacist is not available
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
what may you charge for in a repository system pharmacy?
handling fee (max $20)
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
Is there ever a situation where non-FDA approved drugs may be imported into the United States?
life threatening condition and no efficacious treatment in US can be mailed to the person
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)
Are pharmacies in Ohio legally required to keep perpetual inventories of C-IIs?
no, not legally required to do this
Do fair balance and true statement apply to reminder advertisements
no.
carisoprodol became a controlled substance (C-IV) on January 11, 2012. When was an inventory of your pharmacy's carisoprodol stock required?
on or before January 11th, 2012
When must a complete controlled substance inventory be conducted when closing a pharmacy?
on the day it closes
How many boxes may be checked on a preprinted prescription pad containing multiple noncontrolled substance options?
only 1 box and strength may be checked
May anyone re-import FDA approved drugs?
only the manufacturer can do this
Who may request for easy open caps?
patient's can request, prescribers can also but have to specifically request on every single prescription
Institutional Pharmacy: Who is in charge in a hospital pharmacy?
pharmacy director
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
2 important determinants of duty?
relationship & forseeability
pricing advertisement by a pharmacy is considered to be _________ advertising by the FDA
reminder
who may fill at repository system pharmacies?
residents of ohio with no means to pay for rx
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 the drug repository system?
system which allows unused drugs to be recycled for use by patients who otherwise could not afford them
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
True/False: FDA requires true statement and fair balance for drug advertisements
true
True/False: FTC is strict for standards regarding false advertising & states you are at fault regardless of intent or knowledge
true
True/False: reconstituting by pharmacists is considered to be compounding
true
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 of chronic weight management medications, how many refills may the physician provide the patient?
up to 5 refills in 6 months
When don't you 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 and must re-do entire form
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
A pt calls stating they have a Rx for gabapentin and want to know the price for a months supply, are you legally allowed to provide this pricing information to them?
yes
Can a help seeking ad have the company name in the ad?
yes
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
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
What controlled substances records can be kept off-site?
Shipping records
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
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
A pharmacist that is the responsible person at a pharmacy must sign what license?
TDDD
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?
Technically *no*, because the pharmacist must be immediately available to answer any questions or discuss the prescription with the caller.
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
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
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
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).
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.
Is anything required if a patient (or caregiver) refuses counseling?
The refusal must be documented in the presence of the patient or caregiver
If a controlled substance order is not delivered to the pharmacy, who is responsible for reporting the loss or theft? Which form should be used?
The supplier should submit the DEA Form 106
Warning statements are required when appropriate on nonprescription drugs with electrolytes. What is required?
The warnings can be combined if listed in alphabetical order