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Dispensing controls
Law Test 2 Chapter 5
| Question | Answer |
|---|---|
| **NOTE: a medication order in a hospital is not a prescription and does not have to follow the strict laws that apply to prescriptions | |
| How many characters are there in a DEA # | 9 |
| How many alphabets and digits are in the DEA# | 2 letters and 7 numbers |
| Give the possible beginning letter of the DEA # for the following: 1. Dispenser 2. Mid level practitioner 3. Distributor | 1. Dispenser: A,B,F 2. Mid level: M 3. Distributor: P or R |
| What is the 2nd letter of the DEA# usually | the first letter of the registrants last name |
| Give the steps to verifying a DEA number | 1. add the 1st 3rd and 5th numbers 2. add the 2nd 4th and 6th number and multiply the total by 2 3. then add the sums of steps 1 and 2 together and the last digit of the sum should be the same as the last digit of the persons DEA number |
| Who is the only person that can fill a prescription for a controlled substance | a pharmacist |
| Can a prescriber pre or post date a prescription | NO, must be dates as of the date of issuance |
| Name 10 things that must be included on a controlled substance prescription | PTS: 1. Name 2. address 3. Drug name 4. Strength 5. dosage form 6. quantity prescribed 7. directions for use Practioners: 8. name 9. address 10. registration number |
| What is the 20% rule...if 5% | if more than 20% of what you are selling was made of control substances may need a manuf. DEA# for controls ...if 5% register as a distributor |
| For what schedules can a pharmacist change or correct the pts address | all (II-V) |
| Name changes that can be made to the schedule III-V prescriptions and under what circumstances | 1. add/change dosage form 2. drug strength 3. drug quantity 4. directions for use 5. issue date **after talking with the practitioner first |
| Name 3 things that the pharmacist is never allowed to make changes to on the prescriptions and how can this be "changed" | 1. patients name 2. controlled substance prescribed 3. physicians signature **ultimately can change by calling and getting a verbal prescription if something needs to be changed for the above 3 |
| Can narcotic drugs be prescribed and dispensed to maintain or detoxify an addict | NO, this is illegal...can use schedules III-IV |
| How many refills are allowed for schedule II prescriptions | schedule II prescriptions are NOT allowed refills |
| Give the criteria that must be met in order for a pharmacist to take an oral prescription for a CII in an emergency situation | 1. the quantity prescribed and dispensed is limited only to he emergency peroid 2. the pharmacist immediately puts the prescription in writing 3. pharmacist makes a good faith effort to determine if the physician is registered/authorized |
| 4. prescriber delivers in person or by mail a written prescription | |
| What must the prescription that is delivered by the prescriber say? | Authorization for Emergency Dispensing |
| **If the pharmacist does not receive a script in 7 days they must notify the DEA | |
| Give 3 situations that are an emergency situation for giving an oral/faxed CII script | 1. pt needs it immediately for proper treatment 2. no alternative treatment is available 3. prescriber can not provide a written prescription to the pharmacist bf dispensing |
| When is faxing of a CII allowed | when the pharmacist will receive the original prescription before dispensing and the pharmacy files the original |
| When is a faxed prescription for a CII ok | 1. if the narcotic is to be compounded for direct administration to pt by parenteral, IV, IM, SQ, or intraspinal infusion 2. for LTCF 3. for hospice |
| When can a pharmacist partial a CII | 1. if out of stock 2. if the pt does not want the rest 3. if you believe the prescription is fraud and it would put you at harm to dispense 4. for a long term care facility/terminal illness |
| In what time frame must the partial CII be completed | w/in 72 hours |
| According to the DEA when is it ok to issue multiple prescriptions for controlled substances | 1. can not be more than a 90 day supply 2. legitimate medical use 3. instructions on each Rx for the earliest date to be dispensed 4. don't create risk of diversion/abuse 5. legal under state law 6. complying w/ CSA |
| What is the maximum number of refills for a schedule III and IV prescription | max of 5 refills |
| Give the life of a prescription for CII and CIV | 6 months...these restrictions do not apply to schedule V drugs federally but it applies in the state of LA |
| Can schedule III-IV have partial refills | yes, but the prescription still expires 6 months from the date it was written |
| How many times can a CIII-V be transferred | 1 time if state law applies |
| Name 3 steps that must be one by the transferring pharmacist | 1. write void on the original script 2. get name, address, DEA registration number of pharmacy to the pharmacy where the prescription was transferred 3. record date and name of pharmacist doing the tranfer |
| Name info that is required by the pharmacist receiving a transferred script | 1. date of original script 2. original # of refills 3. date of original dispense 4. # refills remaining 5. transferring pharmacy name, addres, DEA#, prescription # 6. name of tranferor pharm 7. |
| Who does a central fill pharmacy fill prescriptions for | a retail pharmacy |
| What is central fill activity and in the scenario which pharmacy is performing the central fill activity | when a retail pharmacy receives a prescription and sends it to a second pharmacy to be filled and sent back to the retail store for dispensing, the 2nd pharmacy is doing central fill activity |
| If one wants to register as a central fill pharmacy which DEA form should be filled out | form 224 |
| Is it legal for a retail pharmacy to contract with a central pharmacy in another state | yes as long as both states allow the activity |
| Name the 2 ways that prescriptions including controlled substances can be sent from the retail pharmacy to the central fill pharmacy | 1. by fax 2. by electronic transmission |
| who keeps the hard copy of the controlled prescription when using a central fill pharmacy | the retail pharmacy |
| Explain the new years exception | the only time a pharmacist can change the date of a prescription w/o consulting the prescriber...can change the year |
| SEE pg 223 | |
| What does PMP stand for | prescription mgmt program |
| What does the PMP require of the pharmacist | that they send a report of all controlled substances dispensed to the state |
| What does PIC stand for | pharmacist in charge |
| Name the 3 types of records that CSA requires the pharmacy keep for controlled substances | 1. record of inventory 2. record of drug received 3. record of drugs dispersed |
| Name the 3 factors that should equal the controlled substances on hand in the pharmacy | 1. the pharmacies beginning inventory PLUS 2. purchases of controlls during the period MINUS 3. the drugs dispersed during the period |
| what type of charge can be applied to those who do not keep accurate records | diversion |
| How long should records for controlled substances be kept | at least 2 years |
| Name the 3 types of records that can not be kept at a central location | 1. executed forms 2. prescriptions 3. inventory records |
| Records for which controls must be maintain separately from all other pharmacy records | those for CI and CII |
| How should the records for CIII-CV be kept | maintained separately from all other records but they do not have to be separate as long as they are easily retrievable |
| what does "on hand" mean for controlled substances | they are considered to be "on hand" when they are in the possession of or under the control of the registrant |
| Are substances stored at a warehouse for the registrant considered on-hand | yes |
| How often must a registrant take a new inventory | every 2 years |
| For which of the schedules should the count be accurate and when is an estimate allowed | Schedule I and II: must have exact count Schedule III-V: can have an estimate unless the bottle contains more than 1000 tablets, if more than 1000 then an exact count is needed |
| What must be on the inventory record for controlled substances 4 | 1. name of drug 2. strength 3. # of units or volume of each container 4. number of containers |
| What type of record of receipt is acceptable for each schedule | CI-II: DEA form 222 CIII-CIV: the invoice |
| What are records of dispersal | any record that documents the removal of a drug from the pharmacy |
| What can be ID as a record of dispersal | 1. prescriptions 2. record books 3. DEA from 222 4. invoices 5. institutional records 6. records of disposal 7. records of theft or loss |
| name the 3 ways that pharmacies can file prescriptions | 1. in a separate file for CII, a file for CIII-CV, and a file for all other prescriptions 2. a file for CII and a file for CIII-CV w/ the other prescriptions 3. a file for all controlled drugs and file for the other prescriptions |
| Give examples of 2 Schedule V drugs that are do not require a prescription (are not legend drugs) | 1. codeine cough syrup 2. antidiarrheals |
| What is the max amount of a controlled substance that is an OTC and contains opium that can be dispensed | 1. 240mL (8oz) OR 48 dosage units 2. 120mL or 24 dosage units w/in 48 hours |
| Why is it that the sale or transfer by a pharmacy to another registrant of a scheduled III, IV, V drug must be done through an invoice | bc a prescription can not legally be used for this purpose |
| What form should be used to transfer a C2 | DEA 222 |
| ***units distributed to anotehr registrant must not exceed 5% of the total units of controlled substances distributed in 1 year or the pharmacy may be required to register as a dispenser | |
| What form is required to dispose of controlled substances | DEA from 41 |
| how often can a pharmacy request to destroy controls in the presence of 2 other witnesses | 1 time a year |
| Once the DEA receives the form 41, name the 4 courses of action that the person may be instructed to in order to dispose of the controls | 1. tranfer to a registrant authorized to possess the substance 2. delivery to DEA agent 3. destruction in presence of DEA agent or authorized person 4. by any other means authorized by the DEA |
| Why does the DEA feel that it is illegal for a person to bring prescriptions back to the pharmacy for disposal | bc they are allowed to obtain and possess the prescriptions, but not deliver or distribute them |
| What form should be filed with the DEA for lost or theft | form 106 |
| How many copies come with the DEA 222 form | 3 |
| What determines the number of forms that a registrant may obtain | the business activity |
| How many numbered lines are there on the DEA 222 and how many items can be entered on each line | there are 10 lines and can only enter 1 item on each line |
| name the controls where the DEA 222 can only contain an order for these substances | etrophine HCL and diprenorphine |
| What does the purchase do with copy 1, copy 2 and copy 3 of DEA 222 | the purchase submits copy 1 and copy 2 to the supplier and keeps copy 3 for own records |
| If the supplier can not provide all of the order how long do they have to complete the order bf it bc invalid | 60 days |
| What does the supplier do with copy 1 and copy 2 of DEA 222 | the supplier keeps copy 1 and forwards copy 2 to the DEA |
| What does the purchaser do once they receive the drugs from the wholesaler | document on copy 3 what was received, the date |
| What should the supplier do if they receive an order form from the purchaser that they can not read or appears to be altered | return both copy 1 can copy 2 to the purchaser with a letter explaining why it was returned |
| **the forms come in books of 7 forms | |
| How long do executed DEA 222 have to be kept | for 2 years and must be kept at the registered location printed on the order form |