Exam 2 Flashcards
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?
IND- allows them to ship in interstate commerce. .
What must be approved by the FDA before we may legally distribute a new drug in interstate commerce for patient use?
NDA
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, need supplemental new drug application
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?
aNDA (abbreviated NDA)
Need to prove bioequivalence only, allowed to be 80% the same.
Your company wants to maximize the time on the market for one of its drugs whose patent is expiring so it produces an “authorized generic” under a private label. What is the benefit of doing this?
They do not have to make an NDA, its basically just the brand drug.
FDAs purple book
Lists approved biological products with biosimilarity/interchangeability evaluations
First biosimilar FDA approved
Zarxio biosimilar to filgrastim by Amgen
FDA found no clinically meaningful difference in regards to structure/function, animal study data, human PK data, clinical immunogenicity data, clinical safety and efficacy data.
Does biosimilar mean interchangeable?
No
First interchangeable biosimilar product
Semglee interchangeable with Lantus
Can a biosimilar be substituted at the pharmacy without prescriber intervention?
No, within 5 business days after dispensing a biologic for which an interchangeable product is available, regardless of whether a substitution was made, the pharmacist shall communicate to the prescriber which was dispensed.
REMS
Risk Evaluation and Mitigation Strategies
Required risk management plans that use risk minimization strategies to ensure drug benefits outweigh the risks.
FDA can require before or after drug approval.
REMS may contain the following elements:
Medication guide
Communication plan
Elements to assure safe use (ETASU)
Implementation system
How is bioequivalence of generics determined?
Must be same in the following regards to the innovator drug:
(Pharmaceutically equivalent)
Active ingredient
Strength
Dosage form
Route of administration
Must have virtually the same rate and extent of absorption (must be within 80-125% of innovator drug)
Bioequivalence also refers to
Therapeutic equivalent
In the state of Ohio, bioequivalent drugs are referred to as:
generically equivalent drugs
A pharmacist may NOT select a generically equivalent drug if the prescriber:
Handwrites DAW
Indicates that the prescribed drug is medically necessary.
Cannot be preprinted, stamped, default
The pharmacist may not select a generically equivalent drug unless
Its price to the patient is less than or equal to the price of the brand drug
The pharmacist (or the pharmacist’s agent, assistant, or employee) MUST inform the patient (or the patient’s agent):
If a generically equivalent drug is available at a lower or equal cost.
Of the persons right to refuse the generically equivalent drug
(does not apply to any agency that will reimburse the pharmacy or for patients of a hospital or nursing home.
As a pharmacist, how can I determine if a product is generically equivalent?
Use the Orange Book
Orange book
Lists pharmaceutically equivalent drugs in a table and indicates if they are bioequivalent (aka therapeutically equivalent, or “generically equivalent”).
Drug products that the FDA considers to be therapeutically equivalent (generically
equivalent):
Those with no known or suspected bioequivalence problems.Designated AA, AN, AO, AP, or AT, depending on the dosage form.
Those with actual or potential bioequivalence problems that have been resolved
with adequate in vivo and/or in vitro evidence supporting bioequivalence. Designated AB.
Drug products that FDA at this time, considers NOT to be therapeutically equivalent (NOT generically equivalent)
Those for which actual or potential bioequivalence problems have not been
resolved by adequate evidence of bioequivalence. Often the problem is with
specific dosage forms rather than with the active ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX, or B*
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 be written out
If a prescriber writes DAW on a prescription but the patient requests the generic, may we legally perform the substitution?
No
In the state of Ohio, if a prescriber writes “lisinopril” on a prescription may the pharmacist dispense the brand name Zestril instead?
Yes
Any special exceptions in Ohio for substituting epinephrine autoinjectors like
EpiPen®?
Yes, in addition to generic substitution (AB rating in orange book), epi substitution may occur if it is pharmaceutical equivalent, FDA approved, and has not been excluded from BOP
This essentially allows the substitution of an epinephrine autoinjector that
contains the same active ingredient but not the same inactive ingredient even
if it has not been identified in the FDA Orange Book as being a therapeutic
equivalent (i.e. an A rating). Therefore, it would be permissible to substitute
an epinephrine autoinjector that has a BX rating in the Orange Book.
OTC labeling requirements
"Drug facts" label A statement of the identity of the product. This includes (for each drug it contains) established name, general pharmacologic category. The name/address of manufacturer Net quantity of contents of the package Cautions and warnings needed to protect the consumer Adequate directions for use Lot/control # Exp date
Dietary Supplement and nonprescription drug consumer protection act
An amendment to the FDCA
Requires all OTC drugs and dietary supplements to have the manufacturers or retailers domestic address or phone #.
What is the purpose of the Dietary Supplement and Nonprescription Drug Consumer Protection Act?
So consumers may report SAE that occur when taking the product
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, when must companies report pertinent information?
Within 15 days
Federal Anti-tampering Act
Tampering with consumer products is a federal crime.
Tamper proof packaging required for all OTC drugs, cosmetics, devices
What are exceptions from the tamper proof rule?
Dermatologicals
Dentrifices
Insulin
Lozenge-type products
Commericial unit dose labeling requirements
Name of drug
Quantity of active ingredient in each dosage unit
Expiration date
Lot or control number
Name or place of business of manufacturer
What if a pharmacy unit dose packs medications?
Include normal label requirements
For place of business- include pharmacies name or last 7 digits of terminal distributor
For expiration date- 1 year or actual exp date if less
According to 21 CFR §206 all solid dosage forms must be uniquely identifiable
Must be imprinted, unless the pill is too small or has unique physical characteristics
Includes Rx and OTc
Does NOT include dietary supplements.
NDC
Universal product identifier for human drugs
Contains 10 or 11 digits
3 segments of NDC
Labeler code assigned by FDA
Product code
Package code
Does the existence of an NDC on the label mean that it is FDA approved?
No
Does an NDC have to be on the label?
no
Package insert
Part of the labeling, must accompany drug product
Info must be approved by FDA
Required to have highlights, TOC, and list of major labeling changes
BBW
When is a BBW required?
When use may lead to death or serious injury
Is it illegal to prescribe or dispense against a BBW?
No
What if a patient requests a package insert?
Can give or say no
Patient package insert
FDA mandates these be supplied for certain medications.
Must be given with each New and Refill Rx
Do you supply a package insert if the medication is provided by an institution?
Give either with every dose or with first dose and every 30 days thereafter
Failure to dispense the product with a PPI deems the product
misbranded
FDA mandates that MedGuides accompany drugs (that it has determined) pose a serious and significant public health concern.
Part of the product______
labeling
Manufacturers must provide medguides to
distributors/dispensers
Is a MedGuide required for new and refills?
Yes
Are medguides required for patients in an institution?
No
May a pharmacies patient education printout replace a medguide?
No
A competitor calls you ans asks you to transfer all of your favorite patients prescriptions to them. You refuse to do so. Are you allowed to do this?
No, not allowed to refuse transfers unless the transfer is illegal.
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?
- ) Verbal, write out new prescription
2. ) Cant get hold of prescriber, may still fill but must call within 72 hours.
Are prescriptions with checked boxes for drugs allowed?
Yes only if 1 box is checked
When can CIIs be transmitted by fax?
Resident of a long term care facility
Narcotic for a patient in hospice
Compounded sterile product prescription may for narcotic. In these cases, the faxed Rx may serve as the original.
May a registered pharmacy technician take oral prescriptions?
No only certified tech
What conditions need to be met for an oral CII?
Emergency
- ) Immediately reduced to writing
- ) The quantity prescribed is sufficient for emergency period only.
- ) A prescription must be received from the prescriber within 7 days and attached to the emergecy order.
Pharmacists are required to document their positive identification when dispensing a prescription. How may this be accomplished?
- ) Password + randomly generated questions
- ) Badge + password
- ) Fingerprint
- ) Sign
What 3 things can you not change on a C2?
Pt name
Drug
Prescribers signature
You receive a prescription for “Percocet 5/325 mg #60”. Your pharmacy is out of
Percocet but you have plenty of Vicodin 5/300 mg in stock. You call the prescriber
and she states this interchange is okay with her. May you fill the prescription with
Vicodin instead?
No
Any information given to the pharmacist by the patient or caregiver shall be presumed to be accurate, unless there is reasonable cause to believe the information is inaccurate. What are examples of this?
Mental disability
Under the influence
Under 18 years old
What should a pharmacist do if he/she identifies potential issue while performing a DUR?
“Upon recognizing any of the above, a pharmacist, using professional judgement,
shall take appropriate steps to avoid or resolve the potential problem. These steps may include … consulting with the prescriber and/or counseling the patient.”
What if there is an issue with a DDI and the pharmacist did not perform a DUR or identify the issue and the patient was harmed by this omission?
Civil liability
- Pt has to prove that the pharmacist breached duty, that there was harm, that harm was caused by the breach in duty
Who may counsel patients?
Pharmacists and interns
Does positive identification of a person performing counseling have to be kept?
Yes, could keep in a counseling log book.
If someone other than the patient is picking up a prescription, do you still need to offer counseling?
Yes, have to offer counseling for anyone picking up
You work at a mail order pharmacy, Must you offer counseling to patients?
Yes, written toll free number or call and ask
Can you transfer alprazolam?
Alprazolam can only be transferred once unless its in the same real time system.
How often can you transfer non controls?
Non controls can be transferred anytime
May you transfer prescriptions that were put on hold but never filled at your pharmacy?
Yes, as long as its not a controlled substance
What if you receive an e-script for a controlled substance and you dont have it in stock, or the patient wants it filled somewhere else?
Unfilled escript may be forwarded from one DEA registered pharmacy to another.
It must stay electronic.
What diseases can a physician personally furnish a drug for a sexual partner without diagnosis of the partner?
Chlamydia
Gonorrhea
Trichomoniasis
What conditions must be met for EPT?
The intended recipient is a sexual partner of the prescribers pt
The patient reports to the prescriber that the sexual partner is unable or unlikely to be evaluated or treated by a health professional
What is the limit for number of prescriptions for EPT?
max is 1 for patient plus 2 extra
Which weight loss drug is approved for chronic weight management?
Qsymia (phentermine/topiramate ER)
C-II weight loss drugs
Desoxyn (methamphetamine)
Is vyvanse approved for weight loss?
No, binge eating disorder
What OTC or non-controlled weight loss maintenance drugs are FDA approved?
OTC= Alli (orlistat)
Non-controlled- Xenical (orlistat), contrave, saxenda
What schedule controlled substances cannot be used for weight reduction?
Schedule II controlled stimulants cannot be used for weight reduction.
Scheduled III and IV controlled substances may be utilized for weight reduction only if they are:
FDA approved for weight loss
To utilize schedule III and IV controlled stimulants for weight reduction, the prescriber MUST:
Document that the patient has made a “good faith effort” to lose weight through diet and exercise but was unsuccessful.
Determine that the patient has a BMI >30 or >27 with weight related co-morbid factors.
Document that the patient does not have drug or alcohol abuse.
Only prescribe as adjunct to diet and/or exercise
Meet face-to-face at least every 30 days
Document patients dedication to treatment at each visit
Is the patients BMI required to be on a prescription for controlled substance stimulant for weight loss?
No
Total course of treatment for controlled stimulant weight loss management may not exceed
12 weeks
When must a prescriber D/C use of a controlled substance for weight reduction
If the patient has not had a decrease in weight over any 30 day period (except the 1st month of therapy)
Once a patient has been treated with a controlled substance for weight reduction, the patient must have a period of how long where no controlled substances may be used for weight loss (unless transitioning to another drug)?
6 month
J.S completed a 12 week course of Adipex for weight loss on 3/17/21. When can she start taking it again if her weight returns?
9/17/21
If a patient has an interruption of therapy for more than 7 days for weight reduction:
A prescriber may NOT continue therapy
A pharmacist may NOT fill a prescription
6 months must lapse before restarting a controlled substance for weight loss
A patient had his prescription for Tenuate #30 QD fille on 2/1/21, he presents with a new prescription for it on 3/12/21. May you fill it?
No
How often must a physician meet face to face with a patient for chronic weight management therapy?
At least every 30 days for the first 3 months of treatment.
After the first 3 months, the physician may provide up to 5 refills in 6 months. The lapse in therapy rules do not apply.
May a prescriber switch a patient to Adipex-P from Tenuate after 2 months or does a patient have to recieve the same controlled substance during their 12 weeks?
Can switch
After 12 weeks of Adipex-P may a patient be switch to Qsymia?
Yes, Qsymia is for maintenance.
If a prescriber writes for a weight loss drug off label do all of the weight loss rules still apply?
No
Combat Methamphetamine Act of 2005
The OTC sale of “Scheduled listed chemical products” (SLCP)
Includes pseudophedrine, ephedrine, phenylpropanolamine
“PEP” products
Ohio classifies ________ containing products as schedule V controlled substances
Ephedrine
Exceptions: -Primatene, Bronkotabs, Dietary supplements containing ephedrine
Storage requirements for SLCP
Must be behind the counter or in a locked cabinet
When are retailers allowed to sell SLCP?
They must “self certify” to the attorney general. All employees must be trained by content specified from the DEA.
Certification must be renewed yearly
Daily sales limits of SLCP per customer
3.6
Monthly (30 days) sales limits of SLCP per customer
9 g
If mail order, what are the monthly limit of SLCP per customer?
7.5 g
How are SLCP sales monitored?
National Precursor Log Exchange (NPLEX)
What must be recorded for each SLCP sale?
Purchasers name, signature, address, name and quantity of product, date and time of purchase, type of government issued identification
Identification of SLCP customers
Identity must be verified at time of purchase
>18 years old
Must be given directly to the person who signed for it.
The Controlled Substance Act (CSA) requires that every registrant keep a complete and accurate record of all controlled substances.
What are the 3 types of records involved?
Records of inventory
Records of drugs received
Records of drugs dispersed
Do records containing CIIs have to be separated from other records?
Yes, always
You are hired by the chain pharmacy and have agreed to serve as the “PIC”. You must take a controlled substance inventory, along with the out-going PIC, on the effective date of the change in PIC. Which controlled substances require an exact physical count (vs.an “estimated count”)? …. Don’t forget that liquid-based products must be counted as well!
C2s require exact count always
Non-C2 can have an estimate unless the bottle is >1000 count
When must control inventory counts be done?
Yearly
Does an inventory count need to be submitted to the DEA or BOP?
No
The district manager would like you to send your inventory records to the corporate office for safekeeping. May you do this?
No, must be kept at the physical location.
Are pharmacies in Ohio legally required to keep perpetual “running” inventories of CIIs?
No
You notice that your inventory of Demerol #500 count is off by 4 bottles. What do you do?
Call law enforcement
BOP immediately
DEA within 1 day in writing
A BOP inspector comes to your pharmacy and would like to you 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
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?
Pull original prescription and document on it that you filled it.
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?
Filed on the 222 form
3 years
Can you sell Robitussin AC to a 21 year old with a dry, hacking cough
Yes
Can you sell Robitussin AC to a 68 year old who wants to use it for sleep?
No- not an indication
Can you sell Robitussin AC to a 16 year old with a cough that inhibits functioning at work?
No, must be >18
How much Robitussin AC may a patient receive as an “expempt narcotic” without a prescription?
4 oz every 48 hours
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- they dont exist
What information must be documented in the bound record book from exempt narcotic sales?
Name and address of purchaser
Signature of purchaser
Name and quantity of controlled substance sold
Date of sale
Name and legible initials of RPh/Pharmacy Intern who sold the product
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 be in an appropriately labeled container with drug facts label
May you sell Phenergan with codeine as an exempt narcotic?
No, phenergan is Rx only
Is a logbook required to document sales of syringes?
Not for syringes, but required for needles
Can you sell needles to a person using them for crafts?
Yes
Can you sell needles to someone who needs them for livestock?
Yes
Can you sell needles to someone for insulin?
Yes
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, only if they are an authorized user
May you advertise that you sell syringes without a prescription?
no
Track and Trace Law
Title I- compounding quality act
Title II- drug supply chain security act (DSCSA)
Dispensers must receive information from previous owners (3Ts)
Transaction information
Transaction history
Transaction statement
What is considered a “new drug” that would require a NDA?
A drug not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drugs labeling.
An already existing drug that now: contains a new substance, is in combo with another approved drug, has a new intended use, has a different dose or method of admin
Is a compounded product considered a “new drug”?
Compounded products created for an individual patient pursuant to a prescription are exempt from the new drug definitions.
How does a “new drug” become approved by the FDA for distribution?
Preclinical phase Phase I Phase II Phase III NDA
Brand Name Drug Manufacturers
Allows for a 5 year patent extension
From the date of issue, how long are prescriptions valid for in Ohio?
Non controlled- 1 year
CV- 1 year
CII-CIV- 6 months
When must a prescription be filled for the first time?
Within 6 months.
Opioids- within 14 days
How many refills may a noncontrolled and CV prescription have?
As many as desired, up to 1 year from the date of issuance
How many refills can CIII and CIV prescriptions have?
Up to 5 refills in 6 months from the date of issuance.
How many refills on a CII prescription?
None
May a prescriber issue a single prescription for > 30 day supply for a CII?
Yes, if for a legitimate medical reason. However, outpatient opioid prescriptions may not exceed 90 day supply.
When can you combine refills for a 90 day supply?
Non controlled and either a contraceptive or maintenance drug taken regularly
What are the legal requirements for partially filling prescriptions in Ohio?
CIIs may be partially filled for up to 60 days from the date written for patients who are residents of a LTCF or terminally ill. For all other patients, CIIs may be partially filled for 30 days.
When may a pharmacist dispense a medication without a written prescription?
- ) The pharmacy has filled the prescription before.
- ) The pharmacist is unable to obtain authorization from the prescriber.
- ) Pharmacist uses professional judgement.
- ) Does not exceed 72 hours or 30 days if non controlled and pt has had before.
When a pharmacist gives a medication without a prescription, what must they do?
Maintain record for 1 year
Notify prescriber within 72 hours
30 day supply may only occur once in 12 month period
What is required on a prescription label in the state of Ohio?
Date of dispensing Serial number Pharmacy info Patient info Prescriber info Drug info
If the prescription container is too small to include all information, what must be included?
Rx number and name of pt
Do not have to open packs
Is a pharmacy required to dispense medications in child-resistant containers?
Yes, unless the drug is exempt from the requirements or the patient or prescriber requests otherwise.
How may a patient request non-child resistant packaging?
With each individual prescription
or blanket request
How may a prescriber request non-child resistant containers?
With each individual prescription. Blanket requests not allowed.
Patient profiles MUST include what information?
Full name of patient Residential address Telephone number DOB Gender Drug allergies and reactions H/O of active chronic conditions or disease states Other drugs used
How long does a patient profile have to be maintained?
For a period of no less than 1 year from the date of last entry in the profile record.
Why must Ohio pharmacists keep all information immediately available in patient profiles?
Because pharmacists MUST conduct a prospective (before dispensing) drug utilization review (DUR) before dispensing any Rx. Required for new and refill.
What must a DUR include?
Over and under utilization, abuse Inappropriate duration Therapeutic duplication Drug drug or drug disease interactions Incorrect dose Allergy
When is an OARRS report required?
When a patient adds a different or new controlled substance
IF the patient has not had on in last 12 months
A prescriber is located outside of normal area
A patient is from outside normal area
A pharmacist has reason to believe the pt has filled other prescriptions elsewhere
Patient is exhibiting signs of abuse
Are pharmacists required to provide counseling to patients?
Must be offered for any new or refill prescription
How can the offer to counsel be made?
Face to face
To designee
Phone call
