NHa study

Controlled Substance Act

Regulates controlled drugs (schedule I-V)

Continuous Quality Improvement (CQI)

One of the tools that pharmacies can use to identify, review and promote safe medication use. CQI netting’s can be held monthly with key members of the pharmacy

Omnibus Budget Reconciliation Act of 19990 (OBRA’ 90)

A federal statue that requires the pharmacist to offer patient counseling to Medicaid patients

AC

Before a meal

Absolute Contraindications

Medication should absolutely NOT be used because the risk likely outweighs the benefits

Relative Contraindications

Use extra caution because the medication has greater risk for a particular patient

Medication Interaction

Can be negative, neutral or even positive effects ok one of the medications intended therapeutic purposes

Interactions can occur during absorption, distribution, metabolism, and excretion

Pharmacodynamic interaction

Where two different medications have similar effects on the body, producing too much of that effect

USP Chapter 795

Provides the minimum standard for compounding non-sterile products

Durham-Humphrey Amendment of 1951

Created the clear distinction between over-the-counter (OTC) drugs and prescription (legend) medications

Kefauver-Harris Amendment of 1962

Requires medications to be both safe and effective.

Drug Listing Act of 1972

Requires every drug to have a unique 10-digit National Drug Code (NDC) indicating the manufacturer, product, and package size.

Orphan Drug Act of 1983

Provides tax incentives to encourage the development of drugs for rare diseases.

Drug Supply Chain Security Act (DSCSA)

Often referred to as "Track and Trace," it outlines critical steps for building an electronic, interoperable system to identify and trace certain prescription drugs

DEA form 106

Drug Enforcement Administration document used to report the theft or significant loss of controlled substances and related materials.

USP Chapter 800

Provides the minimum standard for handling hazardous products

USP Chapter 797

Provides the minimum standard for compounding sterile products

Risk Evaluation and Mitigation Strategy (REMS)

A drug safety program that can be required by FDA for certain meds with serious safety concerns to help ensure the benefits of the meds outweigh its risks

Patient package insert (PPI)

Patient labeling that can be part of FDA approved prescription drug labeling. PPI’s are required for oral contraceptive and estrogen and voluntary for all other medications

Purple Book

Information regarding biological, biosimilars and interchangeability

Biologics

Biologics are medicines made from living cells or organisms, so they’re much more complex.

Biosimilar

“almost the same”. Must be approved or switched by doctor

Interchangeable biosimilar

FDA says pharmacy can automatically substitute

Occupational Safety and Health Administration (OSHA)

A federal agency that requires employers to provide safe working conditions

Food and drug administration (FDA)

A federal agency that works to ensure the safety and effectiveness of human and veterinary medicines, biologics and medical device’s. They also regulate the safety and food cosmetics devices that emit radiation, and tobacco products.

Medicare modernization act (MMA)

A federal law that overhauled Medicare and created Medicare part D

Poison prevention packaging act (PPA) of 1970

A federal law that requires child resistant packaging for most legend and OTC drugs to prevent accidental ingestion in poisoning.

• 80% of children under 5 cannot open the container and 90% of adults can open the package within 5 minutes

Drug enforcement administration (DEA)

A federal law-enforcement agency that was set up in 1973 to implement drug use laws and fight during trafficking

DEA form 222

A form to order schedule one or two controlled substances

Hydroalcoholic

Elixir

Suspensions

Liquids with small solids contained within the liquid

Viscous Aqueos

Use sterile or purified water but thicker. Ex. Syrup, Jellies

Medication indication, labeled indication, labeled use

Medications that are FDA approved for a specific disease or multiple diseases

Off Label Use

Medications that are used to treat diseases that weren’t approved for the FDA. The medication was approved for something specific but at times can help with other things

Medication guide

Patient labeling that is part of FDA approved prescription drug labeling for certain prescription drugs medication guides are developed by applicants approved by FDA and required to be distributed to patients

DEA Number

A unique identifier assigned to healthcare providers by the DEA to allow them to prescribe controlled substances. The format consists of two ledgers and seven numerical digits

Drug Recall

Method of removing or correcting products that may cause harm or otherwise violate laws administered by the DFA

ISMP

Newsletter published every two month to educate workers about medication error prevention and near misses

Total Parental Nutrition

A method of feeding that bypasses the GI tract. Used when a person can not eat or have fluids by mouth. TPN is made out of amino acids, water, dextrose and electrolytes

Medication Reconciliation

Process of preparing a complete and accurate listing of a patients medications and all related medical information, such as allergies

Merck Manuals

Information on diagnosing and treating medical conditions

1 quart

4 cups

Clark’s rule

Child’s weight divided 150 x dose

Opioid Response Program

CDC created to reduce the risk of overdose deaths

NDC

Labeler, Product, Package Size

FDA Medwatch

National voluntary reporting program

• product quality problems

• unexpected side effects/adverse events

Bioequivalence

determine if a generic medication is basically equivalent. Orange book is the primary reference for determining bioequivalence

Prescription Labels

• Name, address, and number of pharmacy

• prescriber name

• patient name

• date filled

• prescription number

• refills

• expiration date

• med name, strength dosage form, quantity dispensed, drug manufacturer and instructions

• auxiliary labels as needed

Schedule 1 Drugs

No accepted medical use and a high potential for abuse. Examples: Heroin, LSD, Ecstasy

Schedule 2 Drugs

High potential for abuse. Potentially leading to severe psychological or physical dependence. Examples: Fetanyl, Methylphenidate, Adderall

Schedule 3 drugs

Moderate to low potential for physical and psychological dependence. Examples, Acetaminophen with codeine, ketamine, and anabolic steroids (Testosterone)

Schedule IV

Include drugs, substances or chemicals with low risk or dependence. Examples: Alprazolam, Zoloidem, Tramadol

Schedule V

Lower potential for abuse than schedule IV. Used for anti diarrheal, antitussive, or analgesic purposes. Examples: Pregablin, diohenoxylate/atropine

Safety Data Sheet

Information sheet that is required for each hazardous chemical. This includes the properties of each chemical; the physical, health and environmental health hazards; protective measures; and safety precautions for handling, storing and transporting the chemical

Combat Methamphetamine Epidemic Act (CMEA) of 2005

A federal law that regulates the retail sale of drugs contains ephedrine, pseudoephedrine, to a 3.6 g per day and no more than 9 grams in a month

Legen drug

Prescription only drugs

HIPPA

A federal law that established national standards to protect patient privacy

1 KG

2.2 pounds

1 gram

1,000mg

1 tsp

5ml

Room Temp

20-25 degrees celsius

Freezer Temp

-15+ degrees celsius

Pharmacy Duties

Clinical

What is the expiration date for insulin in the fridge? Outside the fridge?

28 days

Room Temperature

20-25 degrees celsius

Refrigerator Temperature

1.7-7.8 degrees celsius

1ml

20 drops

OD

Right Eye

OS

Left Eye

AD

Right Ear

AS

Left Ear

HS

At bedtime

AC

Before Meals

Converting between Celsius & Fahrenheit

5F= 9C+160

DEA 41

Requires two witnesses to dispose of controlled substances

P listed meds

Acutely hazardous medications. Empty containers of these medications are considered hazardous. Ex. Warfarin

D - listed meds

Toxic, ignitable , corrosive or reactive. Ex Albuterol Inhaler

U - Listed Meds

Many chemotherapy’s drugs

What statement regarding the disposal of fentanyl patches is accurate?

Product package insert recommends flushing used patches down the toilet

Orange Book

Comprehensive list of approved and safe medication products with therapeutic equivalence equations that are provided by the FDA. Used to identify generic equivalence for branded drugs to ensure safe substitution.

Red Book

Finding prescription and non prescription medication average and wholesale costs and pricing.

Yellow Book

Health recommendations for international travel

Valid Dea Number

1st 3rd and 5th number add together

2nd 4th and 6th add together and multiply by two then add the two answers. The last digit of your answer should match the last digit in the DEA number

CIII & C IV Refills

• Refills allowed for these meds five times within 6 months from the rx date of issue

• Can transfer only one time to another pharmacy

CII Refills

• Refills are not allowed

• Partial fills are allowed if the entire quantity is not available

• For emergency oral prescriptions, the remaining portion must be filled no later than 72 hours after it was issued

Pseudoephedrine

• 3.6 grams per day

• 9 grams per month

How often is the inventory of controlled substances?

2 years and must also keep records for 2 years

Emulsions

Mixture of oils and water

Non controlled medication is valid for how long and can be filled how often?

1 year from the date written and can be filled as many times in one year as the the prescriber authorizes

What is the maximum number of days before a refill is due that most third-party payers will allow a refill to be processed?

7 days

BIN

6 digit number assigned to a third party

PCN

A secondary identifier that can be used in routing pharmacy claims

Group Number

Identifies the plan a member falls under

Adjudication

Process of transmitting a prescription electronically to the proper insurance company or third party payer for approval and billing

Medicare B

• Covers DME (durable medical equipment) ex. canes hospital beds, wheelchairs

• Diabetes supplies

• Doctors Visits

• Flu shots and Hep B

Medicare D

• Covers most prescription drugs

• Vaccines not covered by part B

Medicare A

• Covers Hospital visits

DAW 1

Substitution not allowed by prescriber

DAW 9

Substitution allowed by prescriber but plan request brand

Handwashing

• Minimum of 30 seconds

• wet hand, waisted and forearms up to elbow

• hold hands in upright posturing; this means that water will flow down from the fingertips to the elbows into the sink