Patient Safety and Quality Assurance Flashcards
MedWatch
MedWatch is the FDA’s safety information and adverse event reporting system. Safety information regarding human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics can be submitted through MedWatch.
Institute for Safe Medication Practices (ISMP)
The ISMP is dedicated to medication error prevention and safe medication use. The ISMP maintains resources related to high-risk drugs, including look-alike/sound-alike drugs and medications to avoid crushing.
prevention strategies
practices implemented to reduce the chances of a medication error and, if it does occur, to reduce the likelihood that it will reach the patient
Examples include fail safes, standardization, and using computerization/automation to assist in pharmacy operations.
Institute for Safe Medication Practices
This is a national organization that supports a medication error reporting program and reviews reported errors in some states, such as Pennsylvania. It also provides lists of health care words and abbreviations to avoid, as well as a list of look-alike/sound-alike drugs.
VAERS
Reactions or unusual side effects should be reported to the Vaccine Adverse Event Reporting System (VAERS), which is monitored by both the CDC and the FDA
Pharmacy informatics
Pharmacy Informatics focuses on using information technology and drug information to maximize medication use.
class II recall
medication may cause temporary adverse health effects that are reversible or if there is a small risk of serious adverse effects
class I recall
medication is likely to cause severe adverse effects or even death
class III recall
medication is not likely to cause a patient to have adverse effects
class IV recall
does not exist—there are only three classes of FDA recalls.
Prescription records can be stored in only three possible ways:
2 files: (CII) and (non-controlled + CIII-V)
2 files: (CII-V) and (non-controlled)
3 files: (CII) and (CIII-V) and (non-controlled)
valid DEA number
Step 1: Add the first, third, and fifth numbers together ( 2 + 6 + 8 =16).
Step 2: Add the second, fourth, and sixth numbers together (4 + 7 + 9=20).
Step 3: Multiply the sum in the second step by 2 (20 x 2 =40).
Step 4: Add the total from steps 1 and 3 together (40 +16 =56).
All transferred controlled substance prescriptions must contain the following:
Original prescription date and dispensing date
Original # of refills authorized and current # remaining
Transferring pharmacy’s DEA number and demographics
Original prescription number
Name of transferring pharmacist
Safety Data Sheets (SDS)
outline appropriate handling, storage requirements, and cleanup procedures for the hazardous product. They are specific for the product listed.
Disposal of hazardous waste
must be separate from the disposal of other waste, and the waste must be labeled as “hazardous drug waste.” It also needs to be stored in a leakproof container that is labeled as such until it is disposed of safely. There is no specific time limit on when hazardous waste must be discarded as long as it is stored properly.
CSOS (Controlled Substance Ordering System)
the online platform for Schedule II controlled substance ordering that has largely replaced the traditional paper format.
PMP
stands for Prescription Monitoring Program.
CMEA
stands for Combat Methamphetamine Epidemic Act.
REMS
stands for Risk Evaluation and Mitigation Strategies
You can use this type of chart and the allegation method to compute the answer to this
When filled in for this problem, it would look like this:
40%12%25%13parts15parts
Number of parts for higher % solution = Desired % in final product - lower % solution: 25 - 12 = 13
Number of parts for lower % solution = Higher % solution - Desired % in final product: 40 - 25 = 15
Add the number of parts together to get a total number of parts: 15 + 13 = 28 total parts
Divide the final volume of the desired product by the total number of parts to get ml/part: 420/28 parts = 15 ml/part
Multiply the number of parts for each % solution by the ml/part to get the volume of each solution you need to add together to get the desired final product:
15 ml/part x 13 parts = 195 ml of 40% solution
15 ml/part x 15 parts = 225 ml of 12% solution
Note: If you had trouble with this problem, be sure you are not rounding too soon. This will result in inaccurate values.
These need to be documented for all compounded products:
Product names and amount/strength of each used including how compound was mixed
A product specific lot number
The name of all the people preparing the compound (e.g., technicians and pharmacist who checks it)
Date of preparation
Storage requirements
Beyond-use dating
Labeling requirements for all prescriptions
How many people should be involved in the physical compounding process of a single prescription?
Only one person should be involved in compounding a single product. The pharmacist will always double-check a compound and verify it for accuracy and completeness like they would for any other prescription. With that being said, this means the pharmacist is not involved in the physical compounding of the prescription if the pharmacy technician compounded it.
Weight/weight (w/w%)
measured in grams of the ingredient/100 grams of the total product:
- 5 mg = 0.4125 grams (There are 1,000 mg in one gram—just move decimal 3 places to the left.)
- 4125 grams/33 grams = 0.0125 = 1.25% (To get a %, multiply by 100—or move the decimal 2 places to the right.)
the process for non-sterile compounding
Using the prescription, create a formula for the intended product including any calculations and specific amounts of ingredients needed.
Wash hands and put on all required PPE.
Obtain any hardware supplies such as a balance or graduated cylinder.
Weigh/measure out all ingredients using the proper measurement tools.
Following the recipe, combine the ingredients in the correct ratios and in the proper order.
Document the exact amounts used and label the final product including final strengths of ingredients.
compounding equipment is legally required to be present in all pharmacies?
All pharmacies are required to have a class A prescription balance that uses brass weights to measure ingredients.
What is an NDC or National Drug Code number
11-digit number consisting of three sets of numbers in this order: the labeler, the drug, and the package size
ac
before meals
qhs
at bedtime
gtt
drop
OS
left eye
What is a lot number?
A lot number gives information about where and when the drug was manufactured.
reverse distribution
process by which a pharmacy sends outdated, unusable drug products back to the drug manufacturer for processing or disposal
