T/F? It is illegal for a doctor to write a prescription for a C2 for himself
False. Nothing prohibits a doctor from writing an Rx for C2's for himself or a spouse, but it is a huge red flag
T/F? A doctor can give a patient multiple Rx for a C2 as long as he writes the actual date the prescription was written, along with provisions as to when each prescription can be filled
True. Because insurance companies often do not cover a 90 day supply of medications, doctors are permitted to write multiple Rx's for the same drug to cover the 90 day period, so long as he does not "post-date," but writes the original date on all prescriptions, but adds provisions such as "Do not fill before 00/00/00"
T/F? Each hospital on a military base must apply for a separate DEA #
False. The military makes their own rules; do not have to apply for DEA # at all
T/F? It is illegal to ship a controlled substance via UPS or FedEx
False. A controlled substance may be mailed through the USPS, UPS, FedEx, etc. There are no restrictions on mailing of controlled substances
T/F? Prescriptions for C2's cannot be accepted via fax
True and False::: Normally, NO faxed Rx's for C2s are valid. There are 3 exceptions:
If you have a home-bound patient on injectible C2 narcotics, faxes accepted
If patient is in nursing home, faxes accepted for any C2 drug.
For legitimate hospice patient, faxes accepted for C2 narcotics for pain.
An order for medication that is to be used immediately for administration....is it considered a prescription?
No, it is a drug order (medication order)
In LTC: how long after a C2 prescription is originally filled before the patient must receive all the medication?
If you partially fill a C2 prescription for a patient, how long do you have to get the remainder of the prescription to the patient?
What should you look for if you get a prescription for buprenorphine?
The doctor's DEA certification # (starting with an X) ON the prescription.
What are the regulations for sale of pseudoephedrine?
-Must be behind the counter.
-No more than 3.6 grams of PSE can be sold to the same customer in the same CALENDAR DAY.
-No more than 9 grams in a 30 day period.
-Must maintain a log book with purchaser name, address, signature, date and time of sale, name of product, and amt sold
-Solid dosage forms must be sold in blister packs.
How long does long term detoxification last?
1-6 months, or 30-180 days.
How many dosage forms are you allowed to bring into the US for personal use?
50 dosage units TOTAL (for all drugs, not 50 dosage units per each medication)
Can a person come back into the US with more than 50 dosage units of a controlled substance if its in the original American container that was dispensed to the individual?
T/F? As long as the medication is in the original container, you can take your medicines with you into any other country while on vacation.
Trick question. We only know the law for the US & cannot guarantee other countries will allow medications into their country.
How do you calculate a DEA #?
-First letter: A if gotten before 1985; B if after.
-Second letter: first letter of last name.
-(1 + 3 + 5) + 2(2 + 4 + 6)= ##
-7th digit of DEA # will be the second digit of the total.
How many refills can a CII-V have according to the CSA? Florida law?
-CSA: no refills on CII, 5 refills within 6 months on CIII-CIV, unlimited refills allowed on CV (rx expires 12 months from date written)
-Florida Law: no refills on CII, 5 refills within 6 months on CIII-CV
Can you fill a prescription for a patient if the doctor has died or retired?
No. All refills are also void at that time.
How many patients can an individual practitioner see at any one time in prescribing CIII-CV for use in maintenance or detoxification?
How many times can a controlled substance prescription be transferred from one pharmacy to another?
What do you do once the controlled substance prescription has been transferred?
You are supposed to pull the hardcopy from storage and write "VOID" on it or have an electronic record stating all of the necessary transfer information and the Rx be invalidated
What can a doctor NOT write a prescription for?
Rx's (like methadone) cannot be prescribed for addiction treatment (except buprenorphine) and medications that have not been approved by the FDA
Can a doctor write a prescription to obtain drugs for office use?
T/F? You are not required to keep C2's locked in a separate area.
True. C2's are not required to be locked up.
From whom does the Dr. get his identification number from when prescribing for detox patients?
Health and Human Services
In regards to the CSA, what 3 things MUST be kept at the physical pharmacy location?
-Executed order forms (222)
-prescriptions (for 2 years from date of last fill),
Is a central fill pharmacy allowed to fill controlled substances? Any exceptions?
Yes but central fill pharmacy must send Rx back to the retail pharmacy and not send it directly to the patient
What is the definition of a compounder according to the CSA?
Any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages, or changes the dosage form of a narcotic drug listed C2-C5 for use in maintenance or detoxification treatment by another narcotic treatment program.
When can you sell a CV without a prescription?
DEA says a pharmacist has permission to sell 4 oz or less in 48 hours, purchasers must be 18 years of age and you MUST ask for ID. A bound record book of sales must be kept (to whom, name, address, date, drug, dosage form, strength, qty sold)
When do you use Form 222?
Anytime there is a sale of a C2 to anyone other than a patient.
What form is used when CII's are lost or stolen?
Unless you file CII, CIII-CV, and non-controlled Rx's in three separate files, what must be done to all controlled Rx's?
On all controlled prescriptions, A letter "C" must be on the Rx
T/F? An inventory can be done anytime throughout the day, as long as it is done during a lull of business.
False. An inventory must be done before you open the store or after you close it. No prescriptions can be filled during the inventory process.
How often does a controlled substance inventory have to be done?
Every 2 years
T/F:: According to the CSA, the name of the pharmacist that fills the prescription MUST be on the label and the prescription.
False. The pharmacist's name MUST be on the prescription, but not on the label.
T/F:: A perpetual inventory showing daily entrance and subtraction of C2's is mandated by the DEA.
False. A perpetual inventory is not mandated. An inventory is only necessary once every 2 years. (However, a perpetual inventory may be a good idea)
T/F:: Doctors do not have to keep records of the supply of drugs in their office, records of the prescriptions they write for patients, or records of the drugs they administer to the patient in the office.
True. Doctors are only required to keep records of drugs that they are charging patients for. (Considered dispensing).
When must a dispenser (pharmacy or doctor) register as a distributor?
When greater than 5% of total sales are to someone other than patients. If 95% of our sales are NOT to patients, we must register as a distributor.
Why was the government allowed to pass the Controlled Substance Act?
Because it affects interstate commerce
What are the three powers specifically delegated to the federal government?
The ability to tax, national defense, and control of interstate commerce.
T/F: The laws concerning Schedule 3 drugs and the laws concerning Schedule 4 drugs are the same.
T/F: Electronic submission of controls is now permitted by the DEA
T/F: We are allowed to sell narcotics to a doctor for use in his office
True. We CAN sell the drugs to the doctor so long as he fills out a Form 222 to submit to us. The doctor can NOT write a prescription for drugs for in office use.
What does it mean when there is a Class 1 drug recall? Class 2? Class 3?
Class 1: the worst, reasonable probability of serious adverse effects on health or death. *if there is a class 1 recall, you are proactive! Find every patient you have given this drug to in the last 90 days, call them! Class 2: will cause temporary or reversible side effects. Class 3: the product is not likely to cause adverse health consequences. This is a technical violation.
Who is in charge of recalling drugs if there is a problem?
If the manufacturer does not voluntarily recall the medication, the FDA will step in and recall it. ***If there is ever a recall, make sure you remove the drug from the shelf!
T/F: A hospital pharmacy must follow FDA labeling requirements.
False: If you are labeling for use WITHIN the hospital, the FDA has no say over the labeling. (Still use common sense: drug, dose, expiration, etc)
If you repackage drugs to sell to someone else (not for use within a hospital), what expiration date does the FDA require be on the repackaged label?
Two options: either 1 year from the date of REPACKAGING, or the ORIGINAL expiration of the drug, whichever comes first.
T/F: If a drug is already available as a commercially made product, we can not compound that drug in the pharmacy.
True. Even if we could make it cheaper for the patient, the FDA does not allow us to compound something already available (either as Rx or OTC).
T/F: We can buy drugs from a Canadian wholesaler as long as we do not try to smuggle it across the border & disclose the purpose for purchase.
False. We cannot buy from a Canadian wholesaler because we can only buy drugs from an FDA approved place.
T/F: It is legal for patients to bring back drugs for personal use that were purchased at a cheaper price in Canada, as long as the drug is also available for purchase in the US.
False. Someone can import drugs for personal use so long as they: 1) do not smuggle it in; 2) disclose purpose at the border; 3) the drug is NOT available in the US. (Technically, the FDA could stop every little old lady)
What is labeling?
The label on the container PLUS whatever drug information is included with the prescription
Who controls direct to consumer advertising for prescription drugs?
Who controls advertising for OTC drugs?
FTC::: Federal Trade Commission (because OTC products are like any other commercially available products that the patient can buy)
Who controls advertising for dietary supplements?
T/F: Dietary supplements are tested for safety, but not for effectiveness.
False. Dietary supplements are not tested for safety or efficacy.
T/F: The Health and Education Act of 1994 states that any topical or ingestible drug can be a dietary supplement, so long as it claims to be a supplement to the diet and is labeled as so.
False. One of the parameters for a drug to be a "dietary supplement" is that the drug must be ingestible. Topical drugs are not included in this category, and therefore canNOT be marketed without being proven safe and effective. The FDA also does NOT feel that sublingual tablets fit into this category of "ingestible"
Drug A was approved for use in adults ages 18-35. It was recently approved for use in children age 12-18. Is this considered to be a "new drug?"
Yes it is considered a new drug
T/F: A pharmacist can dispense an approved drug for an unapproved use.
T/F: A pharmacist cannot dispense a controlled approved drug for an unapproved use.
False. A pharmacist can dispense ANY approved drug for an unapproved use, including a control.
Ipecac syrup is sold OTC in quantities less than or equal to ____ fluid ounce(s).
< or = to 1 fluid ounce
What is the National Poison Control #?
T/F: The American Academy of Pediatrics approves the use of ipecac syrup in doses of 15 mL or less.
False. The American Academy of Pediatrics no longer endorses the use of ipecac syrup. The normal dosing for use however, IS 15 mL.
T/F: Ipecac fluid extract can be used in place of ipecac syrup.
False. There is NO pharmaceutical use for ipecac fluid extract.
T/F: Only prescription drugs must be stamped with a unique identification code.
False. Both prescription and OTC drugs must have an imprinted identification code.
What do the first 5, middle 4, and last 2 numbers of the NDC mean?
The first 5 numbers of the National Drug Code identify the manufacturer. The middle 4 identify the exact drug, and the last 2 identify the package size.
Any drug without the unique identification stamp is considered ________.
Misbranded or adulturated.
What are the 2 exceptions to the oral dosage form identification stamp rule?
Applies to ALL solid dosages form human drug products except for: 1) Drugs extemporaneously compounded by a pharmacist 2) If drugs because of their size, shape, or unique physical characteristics, cant be stamped. (e.g. nitroglycerin tabs: too small and brittle, soft to be stamped)
Who enforces the privacy portion of HIPAA?
The Office of Civil Rights, which is part of Health and Human Services (HHS)
Who is responsible for the standardized electronic submission code sets?
The Center for MMS (Medicaid and Medicare Services)
How long does HIPAA require us to keep records?
According to federal law, how long are we required to keep records?
According to the Prescription Drug Marketing Act, how long are we required to keep records?
T/F:: Only pharmacy interns or technicians can offer counseling services to the patient.
False. ANYONE can offer, "Would you like the pharmacist to talk to you about your medications today?" A pharmacist, intern, technician, clerk, anyone.
According to the Omnibus Reconciliation Act of 1990, when and for whom did pharmacists have to provide counseling?
Whenever there was a NEW prescription for a MEDICAID patient.
Who is in charge of administration for the Poison Prevention Packaging Act?
US Consumer Product Safety Commission
According to the Poison Prevention Packaging Act, what products must be in safety packaging?
-ALL human oral drugs
-ALL controlled substances
-3 topical drugs::: Lidocaine, Dibucaine, Minoxidil
T/F: Both doctors and patients have the ability to do a "blanket authorization" for all of their drugs to be dispensed without safety closures.
False. Patients have the right to do a "blanket auth" and have all their drugs dispensed without safety closures, but doctors can only specify for non-safety dispensing per Rx.
_______ containers, vials, and lids cannot be reused, but _______ containers or bottles can be reused. Why?
Plastic vials cannot be reused;
Glass bottles can be reused. (Still must give a new plastic cap to the glass bottle)
Plastic degrades, but glass does not.
What are 2 examples of drugs that do NOT have to have safety closures?
1) Nitroglycerin tabs:: would be too dangerous to have someone trying to get the cap off when it is an emergency situation.
2) Steroid or birth control dosage packs:: taken in a certain order/regimen
According to the Prescription drug marketing act, you can collect _____of any criminal fines that are levied up to 125,000 dollars.
T/F: Ketek has to be dispensed with a "medication guide."
True. Any drug that posts a serious and significant health concern::: (e.g. accutane, ambien, birth controls) get a "medication guide" (package insert). If you do not give this to the patient, it is considered a misbranded drug.
If a patient receives a prescription for an estrogen product while in the hospital, do they get a package insert?
YES! Before the first dose of estrogen is administered, and again 30 days later if they are still on the medication.
During what phase do you apply for a patent?
During what phase do you notify the FDA & apply for an INDA?
During preclinical testing, after you know the drug is not toxic.
When do you apply for an NDA?
After phase 3
T/F. Class A generics can be substituted without a problem; they are generically equivalent.
Which of the following does NOT require special packaging? A) fluoride B) ethylene glycol C) baby oil D) tramadol E) naproxen
T/F: Propylene glycol is a solvent that is commonly used in pharmacies.
Alcohol is ____ ethyl alcohol; rubbing alcohol is ____ _______ _______ ethanol.
Alcohol is 95% ethyl alcohol; rubbing alcohol is 70% specially denatured ethanol.
A hospital uses _______ alcohol for lab work for inpatients. If the hospital does lab work for private doctors, they use ______ alcohol.
Untaxed for inpatients; taxed for private docs.
What must an agent of the FDA have for him/her to inspect your pharmacy?
Credentials & a Notice of Inspection
What must a DEA agent have for an inspection of the pharmacy?
Credentials, a Notice of Inspection, and an Administration Inspection Warrant
T/F: If asked, you must provide all financial and sales data to a DEA agent within 2 business days.
False. Trick question kinda... The DEA is NOT allowed access to financial, sales, or pricing data unless you consent.
T/F: The DEA is allowed to do an on-site inventory to check against your records.