Lecture 3 - 7/7/2022 Flashcards
Retail Sales limit on ephedrine, pseudoephedrine, PPA
No more than 3.6g/day or 9g/month
Mail order limit on ephedrine, pseudoephedrine, PPA?
No more than 7.5g of the 9g/month can be improved by private or commercial carrier or the postal service
Storage Requirements of CMEA
Keep behind the counter or locked cabinet where customers do not have access
Record keeping requirements of CMEA
- Sales of > 60mg must be recorded
2. Product name, Quantity sold, name & address of purchaser, date & time of sale, purchasers signature must be recorded
What is corresponding Responsibility
Responsibly for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, bur corresponding responsibility rests with the pharmacist who fills the prescription
Legitimate medical purpose
determined by professional judgment based on acceptable treatment in the US
prescription must be issued for legitimate medical purpose by a practitioner acting within the usual course of professional practice
Examples of non-legitimate medical purposes
- Methadone for maintenance/detoxification
- For fictitious patients
- Controlled Substance for general office-use – no, but exception is Vet practice**
- w/o a medical exam
- w/o medical reason for Controlled Substance
- High doses of a narcotic analgesic
PDMP
Prescription Drug Monitoring Programs
PDMP info
- Electronic monitoring of controlled substances ( CII-CV)…some states req Rx only drugs to also be reported ie. Gabapentin in MA
- States must participate in NABP PMP Interconnect
What is NABP PMP InterConnect
Allows for participating PMP’s to securely exchange perception data
NABP Red Flags
- Prescriptions for “cocktailed” medications
- Requests for early refills
- A large portion of prescriptions for controlled substances by one particular prescriber
- Doctors located 100 miles away from pharmacy
- Other pharmacists aren’t filling prescriptions from the particular prescriber
- Patients travel in groups to the pharmacy
- Requests to pay cash for prescriptions
- Patient presents multiple prescriptions for controlled substances from multiple prescribers (“doctor shopping”)
CS Record Keeping
- Registrant req to maintain inventory, a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant
- Requires that all inventory records be maintained at the registered location in a readily retrievable manner for at least 2 years
- Inventory records of C2s must be kept separate from all other controlled substances
CS Inventory Must include
Date of inventory
When it was taken
name of each controlled substance inventoried
Finished form of substance (ie 10mg tab)
Number of dosage units in container (ie 100 tab/btle)
number of containers (ie 4 100tab belts)
count of substance
CII inventory must be….
an actual physical count
CIII - CV inventory may be…
an estimated count or measure of contents unless the container holds more than 1,00 tabs/capsules then it has to be an exact count
What are the required inventories
Initial & Biennial