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You must notify BNDD within __ days if your pharmacy changes locations.
30 days
How long must you retain CII records?
2 years
How often is CS inventory required?
Annually (in Missouri)
Which drugs must be hand counted in a CS inventory?
All CIIs and CIII-V in stock bottles containing more than 1000 units
Which drug counts can be estimated in a CS inventory?
CIII-V in less than 1000 count stock bottles
T/F: If a pharmacy keeps a perpetual inventory they are not required to do an annual inventory of CS.
False. Perpetual inventory does not replace required annual inventory.
How long must records of CS destruction be kept?
2 years
How should CS be stored in the pharmacy?
CII locked; CIII-V locked or distributed throughout inventory
What is the day supply limit on CII Rx?
30 days; unless dx is documented can do 90 days
T/F: Prescriber may give patient 3 scripts for Adderall at one visit.
True. Cannot exceed 90 day supply. Must write "Do not fill until ____".
What is required on a CS Rx?
Date written; patient name and address; name, address, and DEA number of prescriber; drug name, strength, and dosage form; quantity to dispense; directions for use; signature of prescriber
Can a CS Rx be faxed to the pharmacy for fill?
Yes. CII may be faxed to get things started; however, must have original to dispense the drug. CIII-V may be accepted via fax. CII fax is allowable if LTCF or hospice patient.
What is MO RPh prohibited from changing on a CS Rx?
Name, name, name. Patient name, drug name, and prescriber name.
When may a RPh partial fill CII?
Out of stock (must give remainder in 72 hours) and LTCF or terminally ill patients.
Who is responsible for the CS drugs in E-Kits?
The LTCF.
Who regulates CS stock (E-kits) in LTCF?
BNDD. DEA does not register or regulate LTCF.
T/F Narcotic drugs can be used to ween patients off narcotics
False.
Can methadone be prescribed for opioid dependence?
Mostly no. Only for infants (must document that patient is an infant) and practitioner may administer methadone for 3 days as patient is getting placed in narcotic treatment program.
T/F: RPh may dispense CS to directly to a prescriber for office use.
False. Must obtain a patient-specific Rx.
T/F: MO prescribers may prescribe CS for themselves.
False.
T/F: MO mid-level practitioners may not prescribe to family members.
True.
How does BNDD define "insignificant loss"?
Insignificant loss is breaking a tablet or liquid sticking to the side of the bottle. You know where the drug is. It was not LOST. Requires documentation and attach to inventory.
How must you report loss or theft to BNDD?
Immediately report via phone, fax, or email. Must submit loss report within 7 days.
T/F An agent from a prescribers office calls to authorize an emergency fill of hydromorphone for pain for a patient requiring potent pain meds ASAP. She states the pain is so severe only hydromorphone will do. She only authorizes a 3 day amount and will have the Rx to you within the next few days. This is legal.
False. Emergency fills can only be verbally authorized by prescriber, not an agent.
How many refills are allowable on CIII-IV Rx?
5 refills
How many refills are allowable on CV Rx?
As authorized by physician.
What is the quantity limit on CIII-V Rx?
90 day supply
How long is a CIII-IV Rx valid?
6 months
How long is a CV Rx valid?
1 year
What does CMEA stand for?
Combat Methamphetamine Epidemic Act
Which form is used for new pharmacy registration with DEA?
DEA Form 224
Which form is used to renew pharmacy registration with DEA?
DEA Form 224a
Which form can be used to renew pharmacy registration with DEA for a chain pharmacy?
DEA Form 224b
What is required when a pharmacy chooses to terminate its registration with the DEA?
Return DEA registration certificate and unused DEA 222 Forms.
Which form is used by manufacturers to register with the DEA?
DEA Form 225
What color is Copy 1, Copy 2, and Copy 3 of DEA 222 form?
Copy 1 is brown. Copy 2 is green. Copy 3 is blue.
What happens to each copy of the DEA 222 Form?
Purchaser keeps Copy 3 for their records. Purchaser sends Copy 1 and 2 to the supplier to request drug order be filled. Supplier retains Copy 1 for their files. Copy 2 is forwarded to the DEA by the supplier. When purchaser receives drug order he/she should record, on Copy 3, the # of each item and date received.
If a supplier cannot fill a particular drug on the Form 222 submitted by the purchaser, how long does the supplier have to ship that item?
60 days.
Which form is used when a registrant destroys CS inventory?
DEA Form 41
When a reverse distributor is used for destruction, who is responsible for submitting DEA Form 41 to the DEA? Pharmacy or reverse distributor?
Reverse distributor is responsible.
T/F In order for a person to work in a pharmacy after having been convicted of a felony related to CS, a waiver must be approved by the DEA.
True.
Theft occurs at your pharmacy. How long do you have to notify the DEA?
Notify DEA within one business day of discovery. Notification should be in writing.
Which form is required to report theft or loss of CS to the DEA?
DEA Form 106
How does the DEA define "significant loss"?
DEA does not define significant loss. They say you should use professional judgement.
A tote containing CS goes missing in-transit from the distributor to the pharmacy. This is recognized before the pharmacist signs for the delivery. Who is responsible for reporting the loss/theft to the DEA? Supplier or pharmacy?
The supplier is responsible.
A tote containing CS drugs is missing one bottle of methylphenidate. The pharmacist discovers the drug is missing while putting the drug order away. Who is responsible for reporting the loss/theft to the DEA? Supplier or pharmacy?
The pharmacy is responsible.
Per the Controlled Substance Registrant Protection Act, when is a federal investigation appropriate following a theft of CS?
Federal investigation is warranted if cost of stolen CS is greater than $500, interstate or foreign commerce is involved, or if a person is killed or significantly injured as a result.
T/F Hydrocodone/APAP gets re-scheduled as CII. The pharmacist is required to do a full CS inventory at the time of re-scheduling?
False. The pharmacist is required to take inventory of the particular drug that has been re-scheduled on the day this happens.
T/F The DEA requires documentation of Power of Attorney be submitted to them no later than 14 days after RPh is given this responsibility.
False. DEA does not require this. Power of Attorney information should be filed in the pharmacy.
What does CSOS stand for?
Controlled Substance Ordering System
List the letters that may be the first letter of a DEA number.
A, B, F, or M (for mid-level practitioners)
What determines the second letter of a DEA number?
First letter of prescribers last name.
What does it mean if a DEA number starts with X?
This indicates the prescriber is authorized to treat patients with Suboxone. The DEA number starting with X must be present on Rx for Suboxone.
How many numbers are in a DEA number?
Seven numbers.
How do you determine a DEA number is valid?
Should begin with A, B, F, or M. The second letter should be first letter of last name (keep in mind may reflect maiden name for females). Add digits 1, 3, 5. Add digits 2, 4, 6 and multiply by 2. Add sum of first equation and sum of second. The last digit of this sum should match last digit of DEA number.
T/F A patient requests to have Rx for alprazolam transferred to another pharmacy. The pharmacist may delegate the task to a tech if he/she is busy with a customer.
False. CS transfers must be done between two RPhs!
John Smith is a LTCF patient with an order for Oxycontin. The pharmacist received the order from the physician and has been partial filling. How long is the CS order good for in LTCF patients?
60 days
T/F A pharmacy is going to mail a Rx for zolpidem to a patient. They are required to stamp a 2" C on the envelope prior to mailing.
False. CS may be mailed if the mailer has a DEA registration and it is packaged in plain paper with no indication that it contains CS.
What does SLCP stand for?
Scheduled listed chemical products.
How much pseudoephedrine can a person purchase in one day?
No more than 3.6 grams of SLCP-containing product.
How much pseudoephedrine can a person purchase in 30 days?
No more than 9 grams of SLCP-containing product.
What is required on the logbook to dispense SLCP-containing products?
Name and address of purchaser, date and time of purchase, amount of product purchased, and patient signature.
T/F ID is only required if person purchasing SLCP-containing product is less than 18 years of age.
False. Photo ID is required for all SLCP purchases.
Where can the MO Pharmacy Practice Act be found?
Chapter 338 RSMo; 20 CSR-2220
Where is MO Controlled Substance Act found?
Chapter 195 RSMo; 19 CSR-30-1
Describe the composition of the MO BOP?
7 members. 6 members are RPh. 1 is a public member.
Who appoints members to the BOP?
Governor.
Who places drugs in schedules?
Attorney General
How long are MO BOP positions held? Can they be renewed? What is the lifetime limit?
5 years. Can be renewed. No lifetime limit.
Name the pharmacy. Class A.
Retail pharmacy
Name the pharmacy. Class B.
Hospital outpatient
Name the pharmacy. Class C.
LTC
Name the pharmacy. Class D.
Non-sterile compounding
Name the pharmacy. Class E.
Radiopharmaceutical
Name the pharmacy. Class F.
Renal Dialysis
Name the pharmacy. Class G.
Medical gas
Name the pharmacy. Class H.
Sterile compounding
Name the pharmacy. Class I.
Consultant
Name the pharmacy. Class J.
Shared services.
Name the pharmacy. Class K.
Internet pharmacy (90% of volume from internet)
Name the pharmacy. Class L.
Veterinarian pharmacy
What format is required for a MO prescription form?
Two signature lines. Left side: substitution permitted. Right side: DAW.
T/F MO Board of Pharmacy has no jurisdiction over outpatient pharmacies.
False. MO BOP has no jurisdiction over INPATIENT pharmacies.
If revoked, the Board may statutorily prohibit licensee from reapplying for a license for up to ___ years.
Seven years
When is MO pharmacist license renewed?
Every two years. On even numbered years.
How many CE hours are required per 2 year registration period for a pharmacist?
30 hours per 2 years
How long must a RPh maintain record of CE?
Must retain proof of CE x 2 renewal cycles (4 years)
You change employers. You must notify MO BOP within ___ days of taking your new position.
Within 15 days
T/F You may only serve as PIC at one pharmacy due to the time requirements of the position.
False. You may serve as PIC at more than one pharmacy.
T/F The BOP does not need to be notified when new PIC is selected.
False. BOP should be notified immediately. New PIC can serve immediately. Must submit change of PIC form to the Board.
T/F MO law requires 1 pharmacist for every 5 technicians working in a pharmacy.
False. MO has no tech limits. But, requires techs be under "direct supervision and responsibility" of pharmacist
T/F All pharmacies must have an alarm system and security cameras.
False. Must have "adequate security to deter theft" of drugs.
T/F RPh and tech licenses must be displayed in the pharmacy and be accompanied by a 2x2" photo.
False. Only RPh license requires photo.
T/F You may move your pharmacy to a new location as long as you notify the Board of this move within 7 days of the move.
False. To move locations you must submit a new location application. The new location must be approved and inspected prior to moving.
What three changes to the pharmacy are considered "remodeling" according to the Board?
1. change in CII storage; 2. changes to water or sewage connections; 3. changes to physical security of drugs
You are remodeling your pharmacy and temporarily working out a few trailers on the parking lot of your pharmacy. Are you required to submit a new location application to the Board?
Yes. Change of location application is required even for a temporary move to location outside the current pharmacy.
Are non-resident pharmacies required to have a MO pharmacy permit prior to shipping, mailing, or delivering drugs to MO?
Yes.
Out-of-business form must be filed with the Board within ____ days after pharmacy termination.
15 days
T/F Pharmacy owners are instructed to shred their MO pharmacy permit after submitting their out-of-business form to the Board.
False. MO pharmacy permit should be returned to the Board with the OOB form.
T/F In MO, electronic prescriptions are required to have two signature lines for the prescriber to indicate whether substitution is permissible.
False. Not required on electronic Rx. However, prescriber must indicate product selection.