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Schedules of Controlled Medications
What are exempt narcotics
(C-V) It means they DO NOT require a Rx for purchase. They require a purchaser to be approved by the pharmacist, 18 year old + and ID and sign a log book
Examples of Exempt Narcotics
Codeine Cough Syrup
Lomotil ( Diphenoxylate with atropine)
Refills on Scheduled Drugs:
How many refills are allowed for C-II
No Refills Allowed
Refills on Scheduled Drugs:
How many refills are allowed for
C-III, C-IV, C-V
5 refills within 6 months.
Limits of Pseudoephedrine (Sudafed)
3.6 grams per day
9 grams per 30 days
DEA #’s
Required by a prescriber to write Rx for CONTROLLED medications
A prescriber’s DEA # begins with…
A, B, or F
A MID-LEVEL Prescriber’s DEA # begins with the letter ….
M
Calculation for a DEA #
1 + 3 + 5 = 9
2 + 4 + 6 = 12 —→ *2 = 24
9 + 24 = 33
las digit should = final digit of the DEA #
How are hard (Paper) copies of Rx filed:
How are C-II Rx’s filed
Separately all by themselves
How are hard (Paper) copies of Rx filed:
How are C-III, C-IV, C-V filed
Are filed separately or by themselves
What else could
C-III, C-IV, C-V be filed with
can be filed with Non-Controlled Rx but must be marked with a Large Red C
How are Non-Controlled Rx’s filed
by themselves (unless C-III, C-IV, C-V are included)
DEA FORM 41
Used to document the destruction of controlled substances
DEA FORM 106
Used for reporting any theft or loss of controlled substances
DEA FORM 224
Used for a pharmacy to dispense controlled substances
DEA FORM 222
Used to order C-II medication
Also Used to transfer C-II from pharmacy to pharmacy
Triplicate Form
Where does each copy of the triplicate form DEA FORM 222 go
Copy 1: Drug supplier
Copy 2: Sent to DEA
Copy 3: Kept by Pharmacy
What Drugs are safe for Pregnancy
Tylenol (APAP)
Sudafed
Insulin
What drugs aren’t safe for pregnancy
Isotretinoin
Finasteride
Dutasteride
Statins (ex. Lipitor)
NSAIDS
Tetracycline
Prescribers:
MD or DO
Doctors
Prescribers:
DPM
Foot Doctor (Podiatrist)
Prescribers:
DDS or DMD
Dentist
Prescribers:
DVM
Veterinarian
Prescribers:
NP
Nurse Practitioner (MID-LEVEL PRACTITIONER)
Prescribers:
OD
Eye Doctor (Optometrist) (MID- LEVEL PRACTITIONER)
Prescribers:
PA
Physician’s Assistant (MID-LEVEL PRACTITIONER)
Classes of Drug Recalls:
Recalls can be issued by…
FDA or Manufacturer
Recall issued b/c there is a strong chance of serious adverse effects or death
Class 1 Recall
Recall issued b/c there is a temporary (But reversible) chance of adverse effect or little chance of serious adverse effect
Class 2 Recall
Recall issued b/c of a problem not likely to cause adverse effects
Class 3 Recall
NDC # formatting
5 digits - 4 digits - 2 digits
00001-0001-01
The first 5 digits in NDC # indicated for
Identifies Labeler or Manufacturer
The middle digits in NDC # indicated for
referring to package strength and dosage form
The last digits in NDC # indicated for
Identifying package size QUANTITY
How is Insulin measured
Units
How is Insulin delivered
SC (subcutaneously)
What is Insulin indicated for
DM (diabetes Mellitus)
How long is a vial of insulin good for
28 days once it is first used
U- 100 Insulin
100 units of insulin in 1 mL = 100 units/mL
3 classic symptoms of DM (Diabetes Mellitus)
polyphagia
polydipsia
polyuria
Health Care Organizations:
ISMP
Institute for Safe Medication Practices
Health Care Organizations:
ISMP Use
Educate HC (healthcare) workers & the public about medication practices
Health Care Organizations:
CDC
Centers for Disease Control and Prevention
Health Care Organizations:
EPA
Environmental Protection Agency
Health Care Organizations:
EPA use
Oversees the disposal of hazardous waste from facilities
Health Care Organizations:
OSHA
Occupational Safety and Health Administration
Health Care Organizations:
OSHA use
Ensures the health and safety of employees in the workplace
Health Care Organizations:
DEA
Drug Enforcement Administration
Health Care Organizations:
DEA use
Handles all rules with Controlled (Scheduled) Medications, I-V
Enforces the health and safety of employees in the workplace
Health Care Organizations:
FDA
Food and Drug Administration
Health Care Organizations:
FDA Use
Approval of new medications
Inspects & regulates new medications
Issues drug recalls
Reviews New generic equivalents and therapeutic indications for existing medications
QSR’s - Quality System Regulations
regulate the labeling marketing and manufacturing of products under FDA
QSR’s - Quality System Regulations
regulate the labeling marketing and manufacturing of products under the FDA
Health Care Organizations:
HIPPA
Health Insurance Portability and Accountability Act
Health Care Organizations:
HIPPA
Contains PHI (protected health information)
PHI - DOB, diagnosis, medications, etc
Disclose _______ amount of PHI needed to complete the task
MINIMUM
Insurance/Third Party
Tiered Co-payment
Tier 1 - Generic Medications
Tier 2 - Preferred brand medications
Tier 3 - non-preferred brand medicaitons
Insurance/Third Party
Premium
Amount paid- usu per month, as the cost of the insurance
Insurance/Third Party
Coinsurance
Insurer and patient agree to share costs - usually a percentage agreement
Insurance/Third Party
Deductible
Amount the patient must pay before the insurance will start covering health care costs
Insurance/Third Party
Copay
Amount the patient pays for each Rx. Insurance pays part, patient pays part
Insurance/Third Party
Adjudication
When we bill the Rx online - our computer interfaces with the PBM computer to tell us the price to change the patient
Insurance/Third Party
MAC
equals maximum allowable cost the maximum amount that the insurance company ( or their party payer) will pay for a Rx medication on behalf of a patient
Insurance/Third Party
Member ID number
ID # unique to the primary insurance holder
Insurance/Third Party
PCN #
Secondary identifier used in routing claims
Insurance/Third Party
Person Code
Identifies which household member is receiving services
Insurance/Third Party
Rx group #
Identifies the plan a member falls under
Insurance/Third Party
BIN #
The # that tells the computer who to send the claim to for processing
Inventory:
When you receive a shipment of medication be sure to _________ the purchase order
Reconcile (compare)
Inventory:
FIFO
First in, First out
Inventory:
ROP/ROQ
reorder point / reorder quantity
Inventory:
PAR
periodic automatic replacement
Inventory:
Where is medication that is pulled from inventory kept until it can be destroyed or disposed of
In a designated space away from meds that are used so they aren’t mistaken as usable
Inventory:
How often should inventory be checked and inspected
Daily
Inventory:
How many months before the med expires should it be MARKED
6 months
Inventory:
How many months before the med expires should it be pulled from inventory
3 months
Inventory:
What is the minimum and Maximum bottles allowed on the shelf
Minimum = 3
Maximum = 10
Storage Temperature:
What is Room Temperature
(68-77 F)
(20-25 C)
Storage Temperature:
What is Refrigerator Temperature
(35-46 F)
(1.7-7.8 C)
Storage Temperature:
What is Freezer Temperature
(5 F)
(-15 C)
Medicare:
Part A
Covers hospital stays, hospice, skilled nursing facilities, home health care
Medicare
Part B
Covers DME (wheelchairs, walkers, oxygen tanks etc.) and glucose test strips, lancets, glucose meters
Medicare
Part C
Covers managed care
Medicare
Part D
Covers Rx drugs, insulin, vaccines & biologicals
References:
Red Book
Provides comprehensive drug information, including pricing and product identification.
References:
Orange Book
Lists FDA-approved drug products and their therapeutic equivalence.
References:
USP-NF
A compendium of official standards for drugs, food ingredients, and dietary supplements.
References:
The Handbook on Injectable Drugs
A reference guide for the preparation, stability, and compatibility of injectable drugs.
References:
SDS
Provides detailed information on the safe handling, storage, and hazards of chemicals.
Suspensions & Emulsions always need to be ….
Shaken
An ELIXIR is a liquid that contains ….
Alcohol
Elixirs, extracts, tinctures, all contain
Alcohol within all of them
UNG
ointment
Buccal Tablets
Placed in the cheek
SL (sublingual) tablets
Put under the tongue
Capsule 000
Largest size capsules
Capsule 5
Smallest size capsule
Federal Drug Laws:
The Durham-Humphrey Amendment of 1951
It created a distinction between “OTC and Legend Rx Drugs” and allowed for refills
Federal Drug Laws:
The Kefauver-Harris Amendment of 1962
Drugs need to be safe and effective
Federal Drug Laws
Controlled Substances Act (CSA) / Comprehensive Drug Abuse and Prevention Act of 1970
This created the DEA and controlled substances and the C-I,C-II,C-III,C-IV,C-V levels