Prescriptions- Label
What words need to be used for expiration date?
"use by _______"
Just read: What are the things which need to be on the COMMERCIAL label of a prescription drug?
-name and dose -name and address of the manufacturer, packer, or distributor -the recommended usual dosage -inactive ingredients (if not oral) -route of admin (if not oral) -lot number or control number -description of the type of container the pharmacist should use for dispensing unless its already ready for the consumer or is unit dosed -the statement "Rx only" -if habit forming that needs to be on there -number/quantity in container -the schedule if a control
The federal warning statement need not appear on the Rx label for: 1) CV 2) CIV and CV 3) CII and CIII 4) non-controls 5) "blind" clinical investigations of controls Pick em
1, 4, and 5
What additional information needs to go on a label if the drug is a control?
1. Pharmacy NJ registry number (different from the DEA registration) 2. Federal warning statement
What should be on a compounded sterile preparation label?
1. date and time prepared 2. name of prescriber (only in retail) 3. name of patient 4. directions for use 5. name and strength or quantity of all active ingredients and name and volume of diluent or vehicle if applicable 6. name, address, and phone number of pharmacy 7. "use by" date- day and time 8. any ancillary and cautionary instructions needed 9. antineoplastic or hazardous substance warnings 10. requirements for proper storage if needed 11. a prescription number
Just read. Here is a list of all the things that need to go on a prescription label for a non-control:
1. name of pharmacy 2. address of pharmacy 3. telephone number of pharmacy 4. number of the prescription 5. date the prescription is filled 6. name of patient**** 7. name of prescriber 8. initials of the pharmacist dispensing the Rx 9. brand or generic name of drug (if generic include the manufacturer)**** 10. strength (if applicable) 11. quantity dispensed 12. directions for use as indicated on the Rx***** 13. expiration date "use by" *****means it needs to be either bolded, colored differently, or in larger font
What things on a label need to be either bolded, colored differently, or in larger font?
1. patient's name 2. name of the drug (brand or generic) 3. directions for use
What additional information needs to be on a prescription label if the prescription is for an animal?
1. the name of the owner 2. the species of animal (Cat Paislee or Dog Daisy)
A sterile IV preparation of a fentanyl drip says use by 1/25/2018. At what time on the 25th is the fentanyl drip presumed to expire?
11:59pm on 1/25/18.
What does the Federal warning statement say?
CAUTION: FEDERAL LAW PROHIBITS THE TRANSFER OF THIS DRUG TO ANY PERSON OTHER THAN THE PATIENT FOR WHOM IT WAS PRESCRIBED
The USP (United States Pharmacopeia) has created a Rx label in regard to content, order in which info should be displayed, size of font, spacing of information, language for directions for use of prescribed drug, appropriate use of auxiliary labels.
I should check that out
Information not required on prescription labels for non-controls: -patient's age -patient's gender -DOSAGE FORM -NUMBER OF AUTHORIZED REFILLS REMAINING -manufacturer's lot/batch number -name of Pharmacist in Charge Additional information not required on prescription labels for controls: -pharmacy DEA number -prescriber's DEA number
Information not required on prescription labels for non-controls: -patient's age -patient's gender -DOSAGE FORM -NUMBER OF AUTHORIZED REFILLS REMAINING -manufacturer's lot/batch number -name of Pharmacist in Charge Additional information not required on prescription labels for controls: -pharmacy DEA number -prescriber's DEA number
Can you confuse people by whether they are getting the brand or generic drug like: Diazepam (Valium)
No if it is diazepam it can not indicate Valium and vice versa. Random but if it is diazepam you also need to mention the manufacturer- don't forget!
What schedule drugs is the Federal warning statement required?
Schedule II - IV but CVs do not need it. Also it is not required or controlled substances dispensed for use in clinical investigations which are blind.
What is it considered if you put the Federal warning statement on non-control substances?
That is misbranding
The name of the prescriber needs to be on every prescription label. When a PA writes a prescription, does the collaborating physician's name or the PA's name go on the label?
The PA's name must go on the bottle. The collaborating physician's name never goes on the label, it is the prescriber that goes on.
The written Rx is for Clinoril 200mg tablets. The prescriber indicated "sig: 100mg bid." The prescription meets all the legal requirements. How is the pharmacist to indicate the dose and identify the drug on the Rx label? a. take one-half tablet twice daily; Clinoril 200mg b. take one tablet daily; Clinoril 100mg c. take one-half tablet twice daily; Clinoril d. take one-half tablet twice daily; Clinoril 100mg e. take two tablets daily; Clinoril 100mg
a. take one-half tablet twice daily; Clinoril 200mg
The federal warning statement must be included on the Rx label for: a. CI and CII b. CII, CIII, and CIV c. CIII, CIV, and CV d. CIV and CV e. non-controls
b. CII, CIII, and CIV
Which of the following is not required on the prescription label of a non-controlled substance? 1) prescriber's name 2) name of PIC 3) patient's age 4) pharmacy's phone number 5) patient's address a. 1 and 3 b. 1, 3, and 5 c. 2 and 3 d. 2 and 4 e. 3 and 5
c. 2 and 3
What is the label vs labelings?
the label is a written, printed, or graphic material attached to the immediate container of a substance. Labeling consists of labels and other written, printed, verbal, or graphic matter upon an article or any of its containers or wrappers accompanying
What if you are dispensing the generic drug? What additional information needs to go on the drug label?
the manufacturer of the generic drug
Which is not required on the label of a controlled substance Rx dispensed by the pharmacist? a. patient's name b. prescriber's name c directions for use by the patient d. name of the drug product being dispensed e. pharmacy's DEA registration
e. pharmacy's DEA registration
